Chemoprophylaxis With Sulfadoxine-pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl
Study Overview
Brief Summary
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.
Detailed Description
Objectives
- To assess the effectiveness of monthly prophylaxis with S/P on haematological recovery in children who have been treated for severe anaemia.
- To measure compliance with the intervention
- To investigate whether or not infection with chloroquine and S/P resistant strains contributes to the pathogenesis of severe anaemia
Study design and methods
Study site:
The study was based at the 75-bed paediatric unit of The Royal Victoria Hospital (RVH), which is located in the capital, Banjul. This is the main referral hospital for the country. The paediatric unit admits about 7000 children a year, of whom about 800 are anaemic (PCV < 33%).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Months to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 3 months to 9 years.
- •Haemoglobin concentration 7g/dl on admission to hospital.
- •Residence within 30 km of the study centre and availability for the duration of the study period.
- •Informed consent to participate in the study given by the parent or guardian.
Exclusion Criteria
- •Simultaneous participation in any other trial.
- •Allergy to sulpha drugs.
- •Residence > 30 km from the recruitment site.
- •Lack of consent.
Outcomes
Primary Outcomes
Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl
Time Frame: at end of the malaria transmission season
hemoglobin concentration
Time Frame: at the end of malaria transmission season
haemoglobin concentration
Time Frame: At the end of malaria transmission season
Secondary Outcomes
- Number of outpatient department (OPD) attendances with malaria(during the surveillance period)
- Number of episodes of severe malaria(during the surveillance period)
- Deaths (all-cause and malaria-specific)(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(during the study period)
- Proportion of children with anaemia (Hb <11g/dl) and those with severe anaemia (Hb <5 g/dl)(at end of the malaria transmission season)
- Number of hospital admissions with malaria(during the surveillance period)
- Mean Hb : Difference between S/P and placebo, Difference between S/P and placebo adjusted for baseline Hb and other covariates(at the end of the malaria transmission season)
- OPD attendance with malaria(during the surveillance period)
Investigators
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine