IPTi in Mozambican Infants for Malaria Prevention
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|ClinicalTrials.gov Identifier: NCT00209794|
Recruitment Status : Unknown
Verified November 2006 by Hospital Clinic of Barcelona.
Recruitment status was: Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : November 16, 2006
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Sulfadoxine-Pyrimethamine (Fansidar)||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1498 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children|
|Study Start Date :||September 2002|
|Estimated Study Completion Date :||December 2005|
- Incidence of first or only malaria episodes in each study cohort by 12 months of age.
- Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
- Incidence of first or only malaria episodes by group up to 24 months of age.
- Incidence of multiple malaria episodes up to 12 months of age.
- Incidence of multiple malaria episodes up to 24 months of age.
- Incidence of overall and severe anaemia up to 12 months of age.
- Incidence of overall and severe anaemia up to 24 months of age.
- Proportion of humoral and cellular immune responses against malaria at 12 months of age.
- Total number of admissions and outpatient attendances up to 24 months of age.
- Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
- 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
- Incidence of side effects in each group up to 12 months of age.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209794
|Centro de Investigaçao em Saude da Manhiça|
|Manhiça, Maputo, Mozambique|
|Principal Investigator:||Clara Menendez, MD, PhD||Center for International Health, Hospital Clinic de Barcelona|