Overview

This trial is active, not recruiting.

Condition malaria
Treatment sulfadoxine-pyrimethamine (fansidar)
Phase phase 1/phase 2
Sponsor Hospital Clinic of Barcelona
Start date September 2002
End date December 2005
Trial size 1498 participants
Trial identifier NCT00209794, TIM

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
time frame:

Secondary Outcomes

Measure
Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
time frame:
Incidence of first or only malaria episodes by group up to 24 months of age.
time frame:
Incidence of multiple malaria episodes up to 12 months of age.
time frame:
Incidence of multiple malaria episodes up to 24 months of age.
time frame:
Incidence of overall and severe anaemia up to 12 months of age.
time frame:
Incidence of overall and severe anaemia up to 24 months of age.
time frame:
Proportion of humoral and cellular immune responses against malaria at 12 months of age.
time frame:
Total number of admissions and outpatient attendances up to 24 months of age.
time frame:
Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
time frame:
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
time frame:
Incidence of side effects in each group up to 12 months of age.
time frame:

Eligibility Criteria

Male or female participants up to 3 months old.

Inclusion Criteria: - Children from study area - Signed informed consent Exclusion Criteria: - History of drug allergies

Additional Information

Official title The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
Principal investigator Clara Menendez, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.