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

Sponsor

Albert Schweitzer Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00167843

Collaborator

Medical Research Unit, Lambarene (Other), Bundesministerium fuer Bildung und Forschung (BMBF) (Other), Deutscher Akademischer Austausch Dienst (Other), German Research Foundation (Other), Bill and Melinda Gates Foundation (Other)

1,189

Enrollment

Location

Duration (Months)

23.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: sulfadoxine-pyrimethamine	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

A Longitudinal Study Assessing the Infectious Status and Immunity of Mothers and Their Children in Lambaréné, Including Intermittent Treatment of Children With Sulfadoxine-pyrimethamine for Malaria Control and Its Impact on Long-term Health

Study Start Date :

Dec 1, 2002

Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

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

Proportion of children with at least one episode of severe anemia []
Proportion of hospitalized children with anemia []
Proportion of hospitalized children with malaria []
Proportion of hospitalized children with any disease []
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 []