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Sponsored by: |
Hospital Clinic of Barcelona |
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Information provided by: | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00209794 |
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
Condition | Intervention | Phase |
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Malaria |
Drug: Sulfadoxine-Pyrimethamine (Fansidar) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children |
Estimated Enrollment: | 1498 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | December 2005 |
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.
Children 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.
Doses 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.
Ages Eligible for Study: | up to 3 Months |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Mozambique, Maputo | |
Centro de Investigaçao em Saude da Manhiça | |
Manhiça, Maputo, Mozambique |
Principal Investigator: | Clara Menendez, MD, PhD | Center for International Health, Hospital Clinic de Barcelona |
Study ID Numbers: | TIM |
Study First Received: | September 13, 2005 |
Last Updated: | November 15, 2006 |
ClinicalTrials.gov Identifier: | NCT00209794 |
Health Authority: | Mozambique: Ministry of Health (MISAU) |
Folic Acid Pyrimethamine Protozoan Infections Sulfadoxine-pyrimethamine |
Parasitic Diseases Malaria Sulfadoxine |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis |
Therapeutic Uses Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Folic Acid Antagonists Pharmacologic Actions |