Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-30 @ 10:21 AM
Study NCT ID:
NCT01122134
Status:
UNKNOWN
Last Update Posted:
2010-05-13
First Post:
2010-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples collected for artesunate drug assays'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-10', 'studyFirstSubmitDate': '2010-05-10', 'studyFirstSubmitQcDate': '2010-05-10', 'lastUpdatePostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters; total area under the plasma concentration vs. time curve (AUC) of artesunate and DHA, maximum plasma concentration (Cmax), time to attain maximum concentration, elimination half life', 'timeFrame': '6 hours', 'description': 'Pharmacokinetic parameters for artesunate and dihydroartemisinin'}], 'secondaryOutcomes': [{'measure': 'Time to 50% parasite clearance (PCT50)', 'timeFrame': '7 days', 'description': 'Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe', 'malaria', 'artesunate', 'intravenous'], 'conditions': ['Severe Malaria']}, 'referencesModule': {'references': [{'pmid': '22540954', 'type': 'DERIVED', 'citation': 'Byakika-Kibwika P, Lamorde M, Mayito J, Nabukeera L, Mayanja-Kizza H, Katabira E, Hanpithakpong W, Obua C, Pakker N, Lindegardh N, Tarning J, de Vries PJ, Merry C. Pharmacokinetics and pharmacodynamics of intravenous artesunate during severe malaria treatment in Ugandan adults. Malar J. 2012 Apr 27;11:132. doi: 10.1186/1475-2875-11-132.'}]}, 'descriptionModule': {'briefSummary': 'Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome', 'detailedDescription': 'The current first line treatment for severe malaria in Uganda is intravenous quinine with artemisinin derivatives as an alternative. Intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. It is generally well tolerated and safe. This study aims is to assess the pharmacokinetics, pharmacodynamics and safety of IV artesunate in treatment of severe malaria in adults admitted to Mulago National Referral and Teaching hospital, Uganda.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population for this study are patients aged 18 years and above. The accessible population will be patients of 18 years and above who present to Mulago hospital with severe malaria. The study population will include patients aged 18 years and above presenting with severe malaria, who fulfill study eligibility criteria and are enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 years and above\n2. With severe malaria according to the following ciriteria:\n3. A positive blood smear for malaria with P. falciparum mono-infection with parasitemia \\> 500 parasites/ul of blood\n4. Who according to the attending physician require parenteral treatment and admission for malaria\n5. Willing to participate in the study\n6. Who are or whose first degree parents/caretakers are able to provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with history of prior antimalarial use within the last 72 hours\n2. Pregnant women\n3. Patients with contraindications to taking the study drugs\n4. Patients taking known inhibitors or inducers of cytochrome P450 -'}, 'identificationModule': {'nctId': 'NCT01122134', 'briefTitle': 'Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients', 'orgStudyIdInfo': {'id': 'CPR 07'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20 adults with severe malaria', 'description': '20 adult patients admitted with severe malaria', 'interventionNames': ['Drug: intravenous artesunate']}], 'interventions': [{'name': 'intravenous artesunate', 'type': 'DRUG', 'otherNames': ['Artesun®'], 'description': 'Intravenous artesunate in a dose of 2.4 mg/kg at start of treatment, 2.4 mg/kg 12 hours later and 2.4 mg/kg/day until the patient is able to tolerate oral therapy. The minimum duration of IV treatment will be 24 hours.', 'armGroupLabels': ['20 adults with severe malaria']}]}, 'contactsLocationsModule': {'locations': [{'zip': '256', 'city': 'Kampala', 'country': 'Uganda', 'contacts': [{'name': 'Pauline Byakika-Kibwika, MSc, MMed', 'role': 'CONTACT', 'email': 'pbyakika@gmail.com', 'phone': '+256 772 626885'}, {'name': 'Mohammed Lamorde, MBBS', 'role': 'CONTACT', 'email': 'mlamorde@idi.co.ug', 'phone': '+256 772 185590'}, {'name': 'Pauline Byakika-Kibwika, MSc, MMed', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ceppie Merry, FRCP, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohammed Lamorde, MBBS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Harriet Mayanja-Kizza, MSc, MMed', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Celestino Obua, MSc, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mulago National Referral hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Pauline Byakika-Kibwika, MSc, MMed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pauline Byakika-Kibwika', 'oldOrganization': 'INTERACT, Makerere University'}}}}