Prevention of Severe Anaemia in Gambian Children

This study has been completed.
Sponsor:
Collaborators:
Department of State for Health and Social Welfare, The Gambia
London School of Hygiene and Tropical Medicine
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00131716
First received: August 18, 2005
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.


Condition Intervention Phase
Anemia
Drug: sulfadoxine-pyrimethamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chemoprophylaxis With Sulfadoxine-Pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl [ Time Frame: at end of the malaria transmission season ]
  • haemoglobin concentration [ Time Frame: At the end of malaria transmission season ]
  • heamoglobin conectration [ Time Frame: at the end of malaria transmission season ]

Secondary Outcome Measures:
  • Proportion of children with anaemia (Hb <11g/dl) and those with severe anaemia (Hb <5 g/dl) [ Time Frame: at end of the malaria transmission season ]
  • Mean Hb : Difference between S/P and placebo, Difference between S/P and placebo adjusted for baseline Hb and other covariates [ Time Frame: at the end of the malaria transmission season ]
  • Number of outpatient department (OPD) attendances with malaria [ Time Frame: during the surveillance period ]
  • Number of hospital admissions with malaria [ Time Frame: during the surveillance period ]
  • Number of episodes of severe malaria [ Time Frame: during the surveillance period ]
  • Deaths (all-cause and malaria-specific) [ Time Frame: during the surveillance period ]
  • Adherence to the study regimen: The number of doses of medication received by children in each group as a proportion of the total number of doses that should have been received [ Time Frame: during the study period ]
  • OPD attendance with malaria [ Time Frame: during the surveillance period ]

Enrollment: 1200
Study Start Date: May 2003
Estimated Study Completion Date: May 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Months to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 3 months to 9 years.
  2. Haemoglobin concentration 7g/dl on admission to hospital.
  3. Residence within 30 km of the study centre and availability for the duration of the study period.
  4. Informed consent to participate in the study given by the parent or guardian.

Exclusion Criteria:

  1. Simultaneous participation in any other trial.
  2. Allergy to sulpha drugs.
  3. Residence > 30 km from the recruitment site.
  4. Lack of consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131716

Locations
Gambia
Medical Research Council Laboratories,
Banjul, Gambia
Sponsors and Collaborators
Gates Malaria Partnership
Department of State for Health and Social Welfare, The Gambia
London School of Hygiene and Tropical Medicine
Investigators
Study Chair: Brian Greenwood, MD London School of Hygiene and Tropical Medicine
  More Information

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131716     History of Changes
Other Study ID Numbers: ITCRVG33.
Study First Received: August 18, 2005
Last Updated: February 7, 2008
Health Authority: Gambia: MRC Ethics Committee

Keywords provided by Gates Malaria Partnership:
prevention
recurrence
severe
anaemia

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
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 August 18, 2014