Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT00403260
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2006-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712628', 'term': 'pyronaridine tetraphosphate, artesunate drug combination'}, {'id': 'D015767', 'term': 'Mefloquine'}, {'id': 'D000077332', 'term': 'Artesunate'}], 'ancestors': [{'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'duparcs@mmv.org', 'phone': '+41 22 555 0300', 'title': 'Stephan Duparc, MD', 'organization': 'Medicines for Malaria Venture'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier', 'description': 'An AE was defined as any unfavorable and unintended sign, symptom, syndrome, or illness that developed or worsened during the period of observation in the clinical study.', 'eventGroups': [{'id': 'EG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine artesunate (180:60mg)\n\nPyronaridine artesunate: once a day for 3 days', 'otherNumAtRisk': 848, 'deathsNumAtRisk': 848, 'otherNumAffected': 389, 'seriousNumAtRisk': 848, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg)\n\nMefloquine plus artesunate: once a day for 3 days', 'otherNumAtRisk': 423, 'deathsNumAtRisk': 423, 'otherNumAffected': 190, 'seriousNumAtRisk': 423, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 60, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 120, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 48, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 41, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Basophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Blood creatinine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Cholera', 'notes': 'Cholera Inaba', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Anaemia haemolytic autoimmune', 'notes': 'Transient auto immune hemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Abortion complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Grand mal convulsion', 'notes': 'Tonic clonic seizure. Treatment-related SAE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Convulsion', 'notes': 'Seizure. Treatment related SAE.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Cerebral malaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 848, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 423, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '99.7'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '99.2'}]}]}], 'analyses': [{'pValue': '0.106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ACPR percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '3.1', 'pValueComment': 'If non-inferiority of PA was demonstrated, the p-value associated with a superiority test is calculated based on a 2-sided Chi-square test. If the calculated p-value is \\<5%, then the superiority of PA compared to MQ+AS was statistically demonstrated.', 'groupDescription': 'Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than 5%.\n\nWas tested versus the alternative:\n\nAlternative hypothesis: the PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than -5%.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction). Non-inferiority of PA to MQ + AS was concluded if the lower limit of the CI for the difference was \\>-5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': "Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure.", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'PCR-corrected ACPR on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.9', 'groupId': 'OG000', 'lowerLimit': '99.3', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '99.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14', 'description': "Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Crude ACPR on Days 14 and 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'title': 'Cure rate (%) on Day 14', 'categories': [{'measurements': [{'value': '99.9', 'groupId': 'OG000', 'lowerLimit': '99.3', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '99.9'}]}]}, {'title': 'Cure rate (%) on Day 28', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '99.4'}, {'value': '96.7', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '98.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 14 and 28', 'description': "Percentage of subjects with adequate clinical and parasitological response (ACPR) on Days 14 and 28, without correction by PCR, defined as absence of parasitaemia on Days 14 and 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure", 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Parasite Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '31.4', 'upperLimit': '31.8'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '31.8', 'upperLimit': '36.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Thick blood films were examined every 8 hours until ≥72 hours or until 2 consecutive negative readings occurred 7 to 25 hours apart, and on Days 3, 7, 14, 21, 28, 35, and 42 (or any other day if the subject returned).', 'description': 'Parasite clearance time was defined as the time from first dosing to time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Fever Clearance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '627', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '16.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '16.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Every 8 hours over ≥72 hours following first study drug administration or temperature normalisation for ≥2 readings between 7 and 25 hours apart, then at each visit.', 'description': 'Fever clearance time was defined as the time from first dosing to first normal reading of temperature (\\<37.5°C taken axillary or tympanic; \\<38°C taken oral or rectal) for 2 consecutive normal temperature readings taken between 7 and 25 hours apart.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Parasite Clearance at Day 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'title': 'Clearance rate (%) at Day 1 (24h after first dose)', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '42.0'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '36.6'}]}]}, {'title': 'Clearance rate (%) at Day 2 (48h after first dose)', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '81.1', 'upperLimit': '86.4'}, {'value': '79.8', 'groupId': 'OG001', 'lowerLimit': '75.6', 'upperLimit': '83.8'}]}]}, {'title': 'Clearance rate (%) at Day 3 (48h after first dose)', 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '93.3'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '93.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 2 and 3', 'description': 'Parasite clearance time was defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Fever Clearance at Day 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '627', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'title': 'Clearance rate (%) at Day 1 (24h after first dose)', 'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '75.2', 'upperLimit': '81.6'}, {'value': '78.9', 'groupId': 'OG001', 'lowerLimit': '74.2', 'upperLimit': '83.2'}]}]}, {'title': 'Clearance rate (%) at Day 2 (48h after first dose)', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '97.2'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '93.6', 'upperLimit': '99.9'}]}]}, {'title': 'Clearance rate (%) at Day 3 (72h after first dose)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '98.2', 'upperLimit': '99.7'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '96.5', 'upperLimit': '99.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 2 and 3', 'description': 'Fever clearance time was defined as the time for at least 2 consecutive normal body temperature measurements (\\<37.5°C axillary/tympanic or \\<38.0°C oral/rectal) to be obtained within an interval of 7 to 25 hours post-dosing.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population subjects completed a full course of study med., did not miss a dose, did not use a concomitant med. that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, and did not have major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Adverse Events and Clinically Significant Laboratory Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '848', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'OG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'classes': [{'title': 'Nr subj. with ≥1 AE', 'categories': [{'measurements': [{'value': '389', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'Nr subj. with ≥1 treatment-related AE', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Nr subj. with ≥1 SAE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nr subj. with ≥1 treatment-related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Nr subj. with ≥1 severe or life threatenining AE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Nr subj. with ≥1 AE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nr subj with ≥1 AE leading to drug discontinuation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Nr subj. with ≥1 AE leading to study withdrawal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier', 'description': 'Cases and severity of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted of all randomised subjects who received any amount of study medication; subjects were analysed as treated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'FG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients randomized and treated.', 'groupId': 'FG000', 'numSubjects': '848'}, {'comment': 'Patients randomized and treated.', 'groupId': 'FG001', 'numSubjects': '423'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '723'}, {'groupId': 'FG001', 'numSubjects': '357'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Re-appearance of P. falciparum', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'P. vivax infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Mixed infection with P. vivax', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Mixed infection with P. falciparum', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'P. vivax infection at screening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'P. ovale infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Gametocyte re-appearance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn from study accidentally', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '848', 'groupId': 'BG000'}, {'value': '423', 'groupId': 'BG001'}, {'value': '1271', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pyronaridine - Artesunate', 'description': 'Pyronaridine - artesunate (180:60mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'BG001', 'title': 'Mefloquine Plus Artesunate', 'description': 'Mefloquine (250mg) plus artesunate (100mg) once a day for 3 days. Posology was based on body weight ranges.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '11.67', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '12.54', 'groupId': 'BG001'}, {'value': '25.1', 'spread': '11.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '60'}, {'value': '23.0', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '59'}, {'value': '23.0', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '634', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '964', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '689', 'groupId': 'BG000'}, {'value': '344', 'groupId': 'BG001'}, {'value': '1033', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Vietnam', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}, {'title': 'Burkina Faso', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'Cambodia', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}, {'title': 'Tanzania', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': "Côte D'Ivoire", 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population, consisted of all randomized subjects who received any amount of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2006-11-22', 'resultsFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2006-11-22', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-20', 'studyFirstPostDateStruct': {'date': '2006-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With PCR-corrected Adequate Clinical and Parasitological Response (ACPR) on Day 28', 'timeFrame': 'Day 28', 'description': "Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure."}], 'secondaryOutcomes': [{'measure': 'PCR-corrected ACPR on Day 14', 'timeFrame': 'Day 14', 'description': "Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 14, defined as absence of parasitaemia on Day 14 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure"}, {'measure': 'Crude ACPR on Days 14 and 28', 'timeFrame': 'Days 14 and 28', 'description': "Percentage of subjects with adequate clinical and parasitological response (ACPR) on Days 14 and 28, without correction by PCR, defined as absence of parasitaemia on Days 14 and 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure"}, {'measure': 'Parasite Clearance Time', 'timeFrame': 'Thick blood films were examined every 8 hours until ≥72 hours or until 2 consecutive negative readings occurred 7 to 25 hours apart, and on Days 3, 7, 14, 21, 28, 35, and 42 (or any other day if the subject returned).', 'description': 'Parasite clearance time was defined as the time from first dosing to time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.'}, {'measure': 'Fever Clearance Time', 'timeFrame': 'Every 8 hours over ≥72 hours following first study drug administration or temperature normalisation for ≥2 readings between 7 and 25 hours apart, then at each visit.', 'description': 'Fever clearance time was defined as the time from first dosing to first normal reading of temperature (\\<37.5°C taken axillary or tympanic; \\<38°C taken oral or rectal) for 2 consecutive normal temperature readings taken between 7 and 25 hours apart.'}, {'measure': 'Parasite Clearance at Day 1, 2 and 3', 'timeFrame': 'Days 1, 2 and 3', 'description': 'Parasite clearance time was defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart.'}, {'measure': 'Fever Clearance at Day 1, 2 and 3', 'timeFrame': 'Days 1, 2 and 3', 'description': 'Fever clearance time was defined as the time for at least 2 consecutive normal body temperature measurements (\\<37.5°C axillary/tympanic or \\<38.0°C oral/rectal) to be obtained within an interval of 7 to 25 hours post-dosing.'}, {'measure': 'Adverse Events and Clinically Significant Laboratory Results', 'timeFrame': 'Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier', 'description': 'Cases and severity of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities'}]}, 'conditionsModule': {'keywords': ['malaria', 'antimalarial', 'P falciparum', 'pyronaridine', 'artesunate', 'artemisinin based combination therapy (ACT)', 'pyronaridine artesunate (Pyramax)'], 'conditions': ['Falciparum Malaria']}, 'referencesModule': {'references': [{'pmid': '22475593', 'type': 'RESULT', 'citation': 'Rueangweerayut R, Phyo AP, Uthaisin C, Poravuth Y, Binh TQ, Tinto H, Penali LK, Valecha N, Tien NT, Abdulla S, Borghini-Fuhrer I, Duparc S, Shin CS, Fleckenstein L; Pyronaridine-Artesunate Study Team. Pyronaridine-artesunate versus mefloquine plus artesunate for malaria. N Engl J Med. 2012 Apr 5;366(14):1298-309. doi: 10.1056/NEJMoa1007125.'}, {'pmid': '26666916', 'type': 'DERIVED', 'citation': 'Ayyoub A, Methaneethorn J, Ramharter M, Djimde AA, Tekete M, Duparc S, Borghini-Fuhrer I, Shin JS, Fleckenstein L. Population Pharmacokinetics of Pyronaridine in Pediatric Malaria Patients. Antimicrob Agents Chemother. 2015 Dec 14;60(3):1450-8. doi: 10.1128/AAC.02004-15.'}, {'pmid': '23433102', 'type': 'DERIVED', 'citation': 'Duparc S, Borghini-Fuhrer I, Craft CJ, Arbe-Barnes S, Miller RM, Shin CS, Fleckenstein L. Safety and efficacy of pyronaridine-artesunate in uncomplicated acute malaria: an integrated analysis of individual patient data from six randomized clinical trials. Malar J. 2013 Feb 21;12:70. doi: 10.1186/1475-2875-12-70.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this phase III clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated P falciparum malaria in South East Asia, India and Africa.', 'detailedDescription': "This is a multi-centre, comparative, randomised, open-label, parallel-group, non-inferiority study comparing the efficacy and safety of a fixed combination of PA to a loose combination of MQ + AS for patients with acute, symptomatic, uncomplicated P. falciparum malaria. The study population will include 1271 patients, comprising male and female children (≥20 kg body weight) and adults, recruited from study sites in South East Asia, India and Africa. Patients will be randomised in a 2:1 ratio to receive either oral PA (180:60mg tablets) or MQ (250mg tablets) plus AS (100mg tablets) once a day for 3 consecutive days (Days 0, 1, and 2). The study drug will be administered by a Third-Party Investigator unblinded to the study treatment, while the Investigator remains blinded.\n\nPatients will be confined to the to the study facility for ≥4 days (Days 0, 1, 2, and 3) and remain near the study site for ≥7 days, or once fever and parasite clearance has been confirmed for ≥24 hours - whichever occurs later.\n\nThe primary efficacy end point for the study is the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.\n\nThe primary efficacy end point for the study is the proportion of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28 (defined as the absence of parasitaemia without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure). Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients between the ages of 3 and 60 years, inclusive.\n* Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.\n* Presence of acute uncomplicated P. falciparum mono-infection confirmed by:\n\n 1. Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or documented history of fever in the previous 24 hours and,\n 2. Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/µl of blood\n* Written informed consent provided by patient and/or parent/guardian/spouse.\n* Ability to swallow oral medication.\n\nExclusion Criteria:\n\n* Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000.\n* Mixed Plasmodium infection.\n* Severe vomiting or severe diarrhoea.\n* Known history or evidence of clinically significant disorders.\n* Presence of significant anaemia, as defined by Hb \\<8 g/dL.\n* Presence of febrile conditions caused by diseases other than malaria.\n* Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, mefloquine or artesunate or other artemisinins.\n* Use of any other antimalarial agent within 2 weeks prior to start of the study as evidenced by positive urine test.\n* Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.\n* Presence of significant renal or hepatic impairment.\n* Receipt of an investigational drug within the past 4 weeks.\n* Known active Hepatitis A IgM, Hepatitis B surface antigen or Hepatitis C antibody.\n* Known seropositive HIV antibody.\n* Previous participation in any clinical study with PA.'}, 'identificationModule': {'nctId': 'NCT00403260', 'briefTitle': 'Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medicines for Malaria Venture'}, 'officialTitle': 'A Phase III Comparative, Open-label, Randomised, Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate (180:60mg) Versus Mefloquine (250mg) Plus Artesunate (100mg) in Children & Adult Patients With Acute Falciparum Malaria', 'orgStudyIdInfo': {'id': 'SP-C-004-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pyronaridine - artesunate', 'description': 'Oral pyronaridine artesunate (180:60mg tablets) once a day for 3 consecutive days (Day 0, 1, and 2). Posology based on body weight ranges.', 'interventionNames': ['Drug: Pyronaridine - artesunate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mefloquine plus artesunate', 'description': 'Mefloquine (250mg tablets) plus artesunate (100mg tablets) once a day for 3 consecutive days (Day 0, 1, and 2). Posology based on body weight ranges.', 'interventionNames': ['Drug: Mefloquine plus artesunate']}], 'interventions': [{'name': 'Pyronaridine - artesunate', 'type': 'DRUG', 'otherNames': ['Pyramax'], 'description': 'once a day for 3 days', 'armGroupLabels': ['Pyronaridine - artesunate']}, {'name': 'Mefloquine plus artesunate', 'type': 'DRUG', 'description': 'once a day for 3 days', 'armGroupLabels': ['Mefloquine plus artesunate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01 BP390', 'city': 'Bobo-Dioulasso', 'state': 'Houet Province', 'country': 'Burkina Faso', 'facility': 'RAOTAP2/Centre Muraz', 'geoPoint': {'lat': 11.18064, 'lon': -4.29489}}, {'city': 'Pailin', 'state': 'Pailin', 'country': 'Cambodia', 'facility': 'Pailin Referral Hospital', 'geoPoint': {'lat': 12.84895, 'lon': 102.60928}}, {'city': 'Abidjan', 'country': 'Côte d’Ivoire', 'facility': 'Institut Pasteur', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'city': 'Mangalore', 'country': 'India', 'facility': 'Wentlock District Hospital', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'city': 'Bagamoyo', 'country': 'Tanzania', 'facility': 'Bagamoyo Research and Training Centre of Ifakara Health Institute', 'geoPoint': {'lat': -6.44222, 'lon': 38.90422}}, {'city': 'Mae Ramat', 'state': 'Changwat Tak', 'country': 'Thailand', 'facility': 'MaeLamad District Hospital', 'geoPoint': {'lat': 16.98403, 'lon': 98.51665}}, {'city': 'Mae Sot', 'state': 'Changwat Tak', 'country': 'Thailand', 'facility': 'MaeSod General Hospital', 'geoPoint': {'lat': 16.71667, 'lon': 98.56667}}, {'city': 'Hanoi', 'state': 'Commune Xy', 'country': 'Vietnam', 'facility': 'NIMPE', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Choray Hospital, Dak O', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Isabelle Borghini-Fuhrer, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medicines for Malaria Venture'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicines for Malaria Venture', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shin Poong Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}