Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-28 @ 7:29 PM
Study NCT ID:
NCT00289250
Status:
COMPLETED
Last Update Posted:
2006-03-01
First Post:
2006-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'C001205', 'term': 'fanasil, pyrimethamine drug combination'}, {'id': 'D000077332', 'term': 'Artesunate'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-12', 'completionDateStruct': {'date': '2001-12'}, 'lastUpdateSubmitDate': '2006-02-28', 'studyFirstSubmitDate': '2006-02-08', 'studyFirstSubmitQcDate': '2006-02-08', 'lastUpdatePostDateStruct': {'date': '2006-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of gametocytes 7 days after treatment'}], 'secondaryOutcomes': [{'measure': 'Presence of gametocytes 56 days after treatment'}, {'measure': 'Asexual parasitaemia 14 days after treatment'}]}, 'conditionsModule': {'keywords': ['Malaria', 'Gametocytes', 'Asymptomatic carriers'], 'conditions': ['Asymptomatic P.Falciparum Malaria']}, 'descriptionModule': {'briefSummary': 'Treatment of uncomplicated P.falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a marked increase in the density of gametocytes. To determine whether treatment with SP enhances gametocyte carriage, we randomized asymptomatic carriers of P.falciparum to receive SP alone, SP with a single dose of artesunate, or placebo, and followed them for 56 days to record gametocyte presence and density.', 'detailedDescription': 'Treatment of P. falciparum malaria with sulfadoxine-pyrimethamine (SP) is followed by a sharp rise in the density of gametocytes. Drug-induced release could enhance transmission of resistant parasites and would argue against the use of SP, especially for intermittent preventive treatment (IPT). We did a randomized trial to determine the effect of treatment with SP on gametocyte carriage. The trial is a three-arm open-label randomized trial. We randomized asymptomatic carriers of P.falciparum to receive antimalarial treatment or placebo, and recorded the prevalence and density of gametocytes over the next 2 months. The trial was conducted during the dry (low malaria transmission) season in four rural villages in The Gambia. Adults and children aged over 6 months who had asexual P.falciparum infection and were confirmed to be free of clinical symptoms of malaria over a 2-day screening period were enrolled and randomized to receive a single dose of SP, or SP plus a single dose of artesunate (SP+AS), or placebo. The primary endpoints were presence of gametocytes 7 and 56 days after treatment, and the duration and density of gametocytaemia over 2 months measured by the area under the curve of gametocyte density against time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* P.falciparum parasitaemia above 20/uL\n* Resident in one of the four study villages\n\nExclusion Criteria:\n\n* Fever\n* Any other sign of clinical malaria\n* Pregnancy\n* Weight \\<5kg\n* History of hypersensitivity to any of the study drugs\n* Treatment with any of the study drugs in the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT00289250', 'briefTitle': 'Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'Effect of Antimalarial Treatment on Gametocyte Carriage in Asymptomatic P. Falciparum: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SCC867'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sulfadoxine-pyrimethamine', 'type': 'DRUG'}, {'name': 'Sulfadoxine-pyrimethamine plus artesunate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'POBOX 273', 'city': 'Banjul', 'country': 'The Gambia', 'facility': 'Medical Reseearch Council Laboratories The Gambia', 'geoPoint': {'lat': 13.45274, 'lon': -16.57803}}], 'overallOfficials': [{'name': 'Margaret Pinder, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Research Council Unit, The Gambia'}, {'name': 'Paul J Milligan, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}, {'name': 'Sam K Dunyo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Research Council Unit, The Gambia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council Unit, The Gambia', 'class': 'OTHER'}]}}}