Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT02427360
Status:
COMPLETED
Last Update Posted:
2018-11-26
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1022}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-22', 'studyFirstSubmitDate': '2015-04-22', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with clearance of asexual parasitaemia within 7 days of initiation of trial treatment', 'timeFrame': '42 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of aparasitaemic patients', 'timeFrame': 'day 3'}, {'measure': 'gametocytaemia', 'timeFrame': '42 days', 'description': 'gametocytaemia will be measured on pre and post treatment'}, {'measure': 'haematocrit change', 'timeFrame': '42 days', 'description': 'Haematocrit changes will be measured on pre and post treatment'}, {'measure': 'Prevalence and temporal trend of resistance molecular markers', 'timeFrame': '42 days', 'description': 'the following molecular markers will be measured; SNP on Kelch/K13 gene and Pfmdr1 copy number'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retrospective Studies', 'Clinical Efficacy'], 'conditions': ['P. Falciparum Malaria', 'P. Falciparum Malaria Mixed Infection']}, 'descriptionModule': {'briefSummary': "This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum species). The review of patients' records and blood samples will be performed for patients treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to December 2013.", 'detailedDescription': "The objective of this study is to evaluate the Day 42 PCR adjusted cure rate of mefloquine-artesunate (MAS3) in patients with P. falciparum\n\nStudy procedure\n\nClinic and patient records and log books will be reviewed and the following clinical information will be extracted: vital signs especially the temperature, clinical signs and symptoms, blood slide and haematocrit result and findings of physical examination (anaemia, jaundice, liver, spleen etc). As a routine, these data were recorded on the clinic patient record and malaria smear microscopy logbook accordingly (which will be regarded as the source documents in this analysis). These source documents will be reviewed and stored specimen will be analysed after getting the permission from the Director of Shoklo Malaria Research Unit, the University of Oxford Tropical Research Ethical Committee (OxTREC)and the Faculty of Tropical Medicine Ethics Committee (FTMEC). These data will be extracted and transcribed into the case record forms and entered into Microsoft access. During the data extraction, the unique ID will be assigned to each patient whereas the patients' name will neither be entered into database nor disclosed in the analysis process (ie: the data will be anonymised)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with uncomplicated P.falciparum malaria or mixed infection (P.falciparum + a non-falciparum species) treated at the clinics of Shoklo Malaria Research Unit between 2003-2013. Medical records and stored/left-over samples from these patients will be reviewed/extracted and used for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of any age and sex who received treatment for uncomplicated malaria and followed up between January 2003 to December 2013\n* Symptomatic of malaria infection, i.e. history of fever or tympanic temperature ≥37.5°c\n* Microscopically confirmed asexual stages of P. falciparum ≥ 5/500 WBC (alone or mixed with non- P. falciparum species)\n* Received fully supervised treatment of mefloquine-artesunate\n\nExclusion Criteria:\n\n* Pregnant woman\n* P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells Signs or symptoms indicative of severe malaria29\n* Mefloquine treatment within the 60 days preceding the current episode of malaria\n* Splenectomy\n\nPatients will be excluded from the efficacy analysis if they didn't finish the 3 days treatment of mefloquine artesunate but still kept in intention-to-treat population."}, 'identificationModule': {'nctId': 'NCT02427360', 'acronym': 'MMA', 'briefTitle': 'Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Evaluating the Efficacy of Artesunate-mefloquine on the Thai-Myanmar Border and the Relative Roles of Resistance Genetic Markers: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'SMRU1409'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mae Sot', 'state': 'Changwat Tak', 'country': 'Thailand', 'facility': 'Shoklo Malaria Research Unit', 'geoPoint': {'lat': 16.71667, 'lon': 98.56667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Texas Biomedical Research Institute', 'class': 'UNKNOWN'}, {'name': 'Nanyang Technological University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}