Reducing the Effects of Malaria in Children by Administering Repeated Preventive Doses

Phase 4

Completed

• Conditions: Malaria

• Registration Number: NCT00167843
• Lead Sponsor: Albert Schweitzer Hospital

Brief Summary

The general goal of the project is to assess the infectious status and immunity of mothers and children living in a malaria region. A major part of the study involves administering an effective antimalarial, sulfadoxine-pyrimethamine (Fansidar®), to children at the same timepoints as vaccinations, i.e. at age 3, 9 and 15 months. The main objective is to study safety, efficacy, and consequences of such a strategy in particular the ability to reduce the risk of anemia.

Detailed Description

More than 1.5 million deaths of African children under 5 years of age are due to Plasmodium falciparum malaria. There is an urgent need for available and affordable strategies to control malaria morbidity in childhood.

Malaria control measures have been assessed for their potential to reduce intensity of infection in order to decrease the risk of malaria. It has been shown that malaria prevention using drugs is potentially capable to reduce malaria morbidity, school absenteeism, and all-cause mortality. However, prevention using drugs in the first years of life can also result in the loss or delay of acquired resistance which can lead to a rebound phenomenon (i.e. an increased risk of severe malaria after the therapy ended). In a recent study on intermittent treatment with Fansidar® at 2, 3, and 9 months of age, the number of malaria cases during the first 12 months of life was significantly reduced and no rebound effect was observed. This study has demonstrated that the intermittent administration of Fansidar® is safe and has beneficial effects for the children. However, the effectiveness decreased some months after discontinuing the drug. The promising effect of the intermittent administration of fansidar shown in this study needs to be confirmed in areas of different endemicity such as Lambaréné, Gabon. It is assumed that a more extended intermittent application of Fansidar® than performed in the above example would likely result in a longer period of protection from malaria, and the extended intermittent administration of Fansidar should not lead to rebound effects resulting in a higher occurrence of malaria.

The framework of this study offers a unique opportunity to study characteristics of infectious disease of importance in the Lambaréné area and the development of resistance against microbes at the maternofetal (mother/foetus) interface. Comparable studies will simultaneously take place in two associated study sites (Kumasi and Tamale) with different malaria endemicity in Ghana, West Africa.

Comparison: Comparison of malaria attacks in children with and without intermittent Fansidar® treatment with drug administration at months 3 and 9 (alongside with routine vaccinations delivered through child vaccination programme) and an additional administration at month 15.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-14
• Study Completion: 2007-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1189

Inclusion Criteria

• Informed consent
• Permanent residence in the study area

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Exclusion Criteria

• Allergy/hypersensitivity to sulfonamides or pyrimethamine
• Signs of severe hepatic or renal dysfunction not due to malaria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy:
The proportion of children with at least one episode of anemia from 3 to 18 months of life
The proportion of children with at least one episode of malaria from 3 to 18 months of life
Safety:
The proportion of children with at least one episode of an adverse event
The proportion of children with at least one episode of a serious adverse event
Rebound:
The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life

Secondary Outcome Measures

Name	Time	Method
Proportion of hospitalized children with any disease
Proportion of hospitalized children with malaria
Proportion of children with at least one episode of severe anemia
Proportion of hospitalized children with anemia
Proportion of children with at least one episode of anemia from 3 to 12 months of life
Proportion of children with at least one episode of malaria from 3 to 12 months of life.
Parasite drug resistance after intermittent sulfadoxine-pyrimethamine and placebo application
Multiplicity of P. falciparum infections after the intermittent treatment
Antibody responses against variable parasite genes after the intermittent treatment
Specific responses to malaria vaccine candidates during the study period

Trial Locations

Locations (1)

Medical Research Unit of the Albert Schweitzer Hospital; 🇬🇦 Lambaréné, Moyen Ogooué, Gabon