Back to resultsIPTi in Mozambican Infants for Malaria Prevention
Primary Purpose
Malaria
Status
Unknown status
Phase
Phase 1
Locations
Mozambique
Study Type
Interventional
Intervention
Sulfadoxine-Pyrimethamine (Fansidar)
Sponsored by
About this trial
This is an interventional prevention trial for Malaria
Eligibility Criteria
Inclusion Criteria: Children from study area Signed informed consent Exclusion Criteria: History of drug allergies
Sites / Locations
- Centro de Investigaçao em Saude da Manhiça
Outcomes
Primary Outcome Measures
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00209794
First Posted
September 13, 2005
Last Updated
November 15, 2006
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00209794
Brief Title
IPTi in Mozambican Infants for Malaria Prevention
Official Title
The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1498 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-Pyrimethamine (Fansidar)
Primary Outcome Measure Information:
Title
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
Secondary Outcome Measure Information:
Title
Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
Title
Incidence of first or only malaria episodes by group up to 24 months of age.
Title
Incidence of multiple malaria episodes up to 12 months of age.
Title
Incidence of multiple malaria episodes up to 24 months of age.
Title
Incidence of overall and severe anaemia up to 12 months of age.
Title
Incidence of overall and severe anaemia up to 24 months of age.
Title
Proportion of humoral and cellular immune responses against malaria at 12 months of age.
Title
Total number of admissions and outpatient attendances up to 24 months of age.
Title
Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
Title
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
Title
Incidence of side effects in each group up to 12 months of age.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Eligibility Criteria
Inclusion Criteria:
Children from study area
Signed informed consent
Exclusion Criteria:
History of drug allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Menendez, MD, PhD
Organizational Affiliation
Center for International Health, Hospital Clinic de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigaçao em Saude da Manhiça
City
Manhiça
State/Province
Maputo
Country
Mozambique
12. IPD Sharing Statement
Citations:
PubMed Identifier
18419347
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.
Results Reference
derived
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IPTi in Mozambican Infants for Malaria Prevention
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