Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT00209794
Status:
UNKNOWN
Last Update Posted:
2006-11-16
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPTi in Mozambican Infants for Malaria Prevention
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1498}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'completionDateStruct': {'date': '2005-12'}, 'lastUpdateSubmitDate': '2006-11-15', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2006-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of first or only malaria episodes in each study cohort by 12 months of age.'}], 'secondaryOutcomes': [{'measure': 'Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.'}, {'measure': 'Incidence of first or only malaria episodes by group up to 24 months of age.'}, {'measure': 'Incidence of multiple malaria episodes up to 12 months of age.'}, {'measure': 'Incidence of multiple malaria episodes up to 24 months of age.'}, {'measure': 'Incidence of overall and severe anaemia up to 12 months of age.'}, {'measure': 'Incidence of overall and severe anaemia up to 24 months of age.'}, {'measure': 'Proportion of humoral and cellular immune responses against malaria at 12 months of age.'}, {'measure': 'Total number of admissions and outpatient attendances up to 24 months of age.'}, {'measure': 'Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.'}, {'measure': 'Proportion of humoral responses and geometric mean antibody titres of polio, DTP and Hepatitis B at 5 months and of measles at 9 and 12 months'}, {'measure': 'Incidence of side effects in each group up to 12 months of age.'}]}, 'conditionsModule': {'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '18419347', 'type': 'DERIVED', 'citation': 'Mayor A, Serra-Casas E, Sanz S, Aponte JJ, Macete E, Mandomando I, Puyol L, Berzosa P, Dobano C, Aide P, Sacarlal J, Benito A, Alonso P, Menendez C. Molecular markers of resistance to sulfadoxine-pyrimethamine during intermittent preventive treatment for malaria in Mozambican infants. J Infect Dis. 2008 Jun 15;197(12):1737-42. doi: 10.1086/588144.'}], 'seeAlsoLinks': [{'url': 'http://www.manhica.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP \\[Fansidar\\] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age', 'detailedDescription': 'The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the EPI scheme at the time of routine immunisations.\n\nChildren will be randomized into placebo and SP treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group.\n\nDoses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those \\<5kg, a half for those 5-10 kg, and a whole tablet for children \\>10 kg). The tablets will be crashed and diluted with water for their administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children from study area\n* Signed informed consent\n\nExclusion Criteria:\n\n* History of drug allergies'}, 'identificationModule': {'nctId': 'NCT00209794', 'briefTitle': 'IPTi in Mozambican Infants for Malaria Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children', 'orgStudyIdInfo': {'id': 'TIM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sulfadoxine-Pyrimethamine (Fansidar)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manhiça', 'state': 'Maputo Province', 'country': 'Mozambique', 'facility': 'Centro de Investigaçao em Saude da Manhiça', 'geoPoint': {'lat': -25.40222, 'lon': 32.80722}}], 'overallOfficials': [{'name': 'Clara Menendez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for International Health, Hospital Clinic de Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}}}}