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

This study has been completed.
Sponsor:
Collaborators:
Medical Research Unit, Lambarene
Bundesministerium fuer Bildung und Forschung (BMBF)
Deutscher Akademischer Austausch Dienst
German Research Foundation
Bill and Melinda Gates Foundation
Information provided by:
Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT00167843
First received: September 11, 2005
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Malaria
Drug: sulfadoxine-pyrimethamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Albert Schweitzer Hospital:

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

Estimated Enrollment: 1189
Study Start Date: December 2002
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent
  • Permanent residence in the study area

Exclusion Criteria:

  • Allergy/hypersensitivity to sulfonamides or pyrimethamine
  • Signs of severe hepatic or renal dysfunction not due to malaria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167843

Locations
Gabon
Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen Ogooué, Gabon, B.P. 118
Sponsors and Collaborators
Albert Schweitzer Hospital
Medical Research Unit, Lambarene
Bundesministerium fuer Bildung und Forschung (BMBF)
Deutscher Akademischer Austausch Dienst
German Research Foundation
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Peter G Kremsner, MD Albert Schweitzer Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00167843     History of Changes
Other Study ID Numbers: 28574
Study First Received: September 11, 2005
Last Updated: January 23, 2013
Health Authority: Gabon: Direction Générale de la Santé

Keywords provided by Albert Schweitzer Hospital:
Malaria
Anemia
Children
Gabon
Intermittent preventive treatment

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 15, 2014