IPTi in Mozambican Infants for Malaria Prevention

Malaria Clinical Trial

Official title:

The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00209794
• Other study ID #: TIM
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: November 15, 2006
• Start date: September 2002
• Est. completion date: December 2005

Study information

• Verified date: November 2006
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mozambique: Ministry of Health (MISAU)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1498
• Est. completion date: December 2005
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Children from study area

• Signed informed consent

Exclusion Criteria:

• History of drug allergies

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Sulfadoxine-Pyrimethamine (Fansidar)

Locations

Country	Name	City	State
Mozambique	Centro de Investigaçao em Saude da Manhiça	Manhiça	Maputo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Mozambique, 

Outcome

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

External Links

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