Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-01 @ 5:41 PM
Study NCT ID:
NCT00453856
Status:
TERMINATED
Last Update Posted:
2007-08-10
First Post:
2007-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 139}}, 'statusModule': {'whyStopped': 'The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-08-08', 'studyFirstSubmitDate': '2007-03-28', 'studyFirstSubmitQcDate': '2007-03-28', 'lastUpdatePostDateStruct': {'date': '2007-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria,'}], 'secondaryOutcomes': [{'measure': 'Determine the frequency of molecular markers for drug resistance'}]}, 'conditionsModule': {'keywords': ['Malaria', 'Sulfadoxine', 'Pyrimethamine', 'Resistance', 'Gabon'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '21569596', 'type': 'DERIVED', 'citation': 'Mombo-Ngoma G, Oyakhirome S, Ord R, Gabor JJ, Greutelaers KC, Profanter K, Greutelaers B, Kurth F, Lell B, Kun JF, Issifou S, Roper C, Kremsner PG, Grobusch MP. High prevalence of dhfr triple mutant and correlation with high rates of sulphadoxine-pyrimethamine treatment failures in vivo in Gabonese children. Malar J. 2011 May 14;10:123. doi: 10.1186/1475-2875-10-123.'}], 'seeAlsoLinks': [{'url': 'http://www.lambarene.org', 'label': '(Homepage of the Medical Research Unit, Lambaréné)'}]}, 'descriptionModule': {'briefSummary': 'IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.\n\nIn order to interpret the results of individual IPTi trials conducted by the IPTi Consortium, and to provide information for policy makers regarding the predicted efficacy of IPTi, it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted. The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the "in vivo efficacy study," which follows a standardized World Health Organization protocol.\n\nA second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage and/or spread of drug resistant P. falciparum parasites.\n\nThirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear.', 'detailedDescription': 'Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged 6-59 month old children in Lambaréné at enrolment, if eligible according to the approved protocol.\n\n139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated malaria. Thereafter each subject will be followed according to the approved protocol\n\nThe proportion of subjects with Adequate Clinical and Parasitological response (ACPR) by day 28, Early Treatment Failure (ETF), Late Clinical Failure (LCF) and Late Parasitological Failure (LPF)will be evaluated.\n\nsecondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients\n* Aged 6 to 59 months\n* Body weight between 7.5 to 30 kg\n* uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL\n* Ability to tolerate oral therapy\n* Informed consent, oral agreement of the child if appropriate\n\nExclusion Criteria:\n\n* Still in IPTi trial and/or still in any other intervention trial\n* Known G6PD-deficiency\n* Presence of severe malnutrition\n* Inability to drink or breastfeed\n* Recent history of convulsions, lethargy or unconsciousness;\n* Signs of severe and complicated\n* Mixed/mono infection that includes a non-P. falciparum species.\n* Hb \\< 7g/dl\n* Inability to attend stipulated follow-up visits.\n* History of hypersensitivity reactions to the drug being evaluated'}, 'identificationModule': {'nctId': 'NCT00453856', 'briefTitle': 'Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children', 'organization': {'class': 'OTHER', 'fullName': 'Albert Schweitzer Hospital'}, 'officialTitle': 'Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné', 'orgStudyIdInfo': {'id': 'IPTi-DRWG- SP Lambaréné'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sulfadoxine Pyrimethamine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B.P. 118', 'city': 'Lambaréné', 'state': 'Moyen-Ogooué Province', 'country': 'Gabon', 'facility': 'Medical Research Unit of the Albert Schweitzer Hospital', 'geoPoint': {'lat': -0.7001, 'lon': 10.24055}}], 'overallOfficials': [{'name': 'Martin P Grobusch, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Research Unit, Albert Schweitzer Hospital Lambaréné'}, {'name': 'Saadou Issifou, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Schweitzer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Schweitzer Hospital, Netherlands', 'class': 'UNKNOWN'}, 'collaborators': [{'name': 'Albert Schweitzer Hospital', 'class': 'OTHER'}, {'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}]}}}