Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-06-26 @ 5:11 AM
Study NCT ID:
NCT00510159
Status:
COMPLETED
Last Update Posted:
2008-01-18
First Post:
2007-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012553', 'term': 'Schistosomiasis haematobia'}], 'ancestors': [{'id': 'D012552', 'term': 'Schistosomiasis'}, {'id': 'D014201', 'term': 'Trematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011223', 'term': 'Praziquantel'}], 'ancestors': [{'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-17', 'studyFirstSubmitDate': '2007-07-31', 'studyFirstSubmitQcDate': '2007-07-31', 'lastUpdatePostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the parasite load between the two treatment arms', 'timeFrame': 'After 28 days'}, {'measure': 'Compare the amount of eggs produced between the two treatment arms', 'timeFrame': 'After 28 days'}, {'measure': 'Compare cure rate between the two treatment arms', 'timeFrame': 'After 28 days'}], 'secondaryOutcomes': [{'measure': 'Evaluate changes in urine appearance before and after treatment', 'timeFrame': 'After 28 days'}, {'measure': 'Evaluate changes in haematuria frequency before and after treatment', 'timeFrame': 'After 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schistosoma haematobium', 'Praziquantel', 'Artesunate + Sulfamethoxypyrazine/pyrimethamine', 'Randomized double blind placebo controlled clinical trial'], 'conditions': ['Schistosoma Haematobium']}, 'referencesModule': {'references': [{'pmid': '19802383', 'type': 'DERIVED', 'citation': 'Sissoko MS, Dabo A, Traore H, Diallo M, Traore B, Konate D, Niare B, Diakite M, Kamate B, Traore A, Bathily A, Tapily A, Toure OB, Cauwenbergh S, Jansen HF, Doumbo OK. Efficacy of artesunate + sulfamethoxypyrazine/pyrimethamine versus praziquantel in the treatment of Schistosoma haematobium in children. PLoS One. 2009 Oct 5;4(10):e6732. doi: 10.1371/journal.pone.0006732.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of praziquantel versus As+SMP (Co-Arinate FDC ®) in the treatment of Schistosoma haematobium in 6-15 year old Malian children. The nul-hypothesis in this study is that the combination of As+SMP is more effective than praziquantel in the treatment of S. haematobium infected children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 6-15 years\n* In good health, according to study doctor\n* Suffering from urinary schistosomiasis, as diagnosed by the presence of S. haematobium eggs in the urine.\n* Residents of Djalakorodji\n* Capable of taking oral medication\n* Written informed consent to participate in the study, obtained from parent or legal guardian.\n\nExclusion Criteria:\n\n* Weighing more than 50 kg\n* Being pregnant or lactating at the time of the study\n* Patient has a severe concomitant disease, as determined by the clinical examination, such as cerebral cysticercosis, HIV,...\n* Signs of severe malnutrition (children weighing/measuring more than 3 standard deviations or less than 70% of the median standard reference values determined by WHO, or with systemic oedema affecting both feet).\n* Hypersensitivity to As, SMP or PZQ\n* Having taken other antimalarial or antischistosomal medication during the study.\n* Having participated in previous similar studies'}, 'identificationModule': {'nctId': 'NCT00510159', 'briefTitle': 'Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dafra Pharma'}, 'officialTitle': 'Randomized Double Blind Clinical Trial in Mali, Comparing the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel in the Treatment of S. Haematobium in Children', 'orgStudyIdInfo': {'id': '2007/S4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Artesunate+Sulfamethoxypyrazine/pyrimethamin', 'type': 'DRUG', 'otherNames': ['Co-Arinate FDC ®']}, {'name': 'Praziquantel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Djalakorodji', 'country': 'Mali'}], 'overallOfficials': [{'name': 'Mahamadou S Sissoko, MD, MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bamako, Mali'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dafra Pharma', 'class': 'INDUSTRY'}}}}