Prevention of the recurrence of anaemia in Gambian children following discharge from hospital.
BACKGROUND
In malaria endemic countries, children who have experienced an episode of severe anaemia are at increased risk of a recurrence of anaemia. There is a need to find ways of protecting these at risk children from malaria and chemoprevention offers a potential way of achieving this objective.


METHODS
During the 2003 and 2004 malaria transmission seasons, 1200 Gambian children with moderate or severe anaemia (Hb concentration <7 g/dL) were randomised to receive either monthly sulfadoxine-pyrimethamine (SP) or placebo until the end of the malaria transmission season in which they were enrolled, in a double-blind trial. All study subjects were treated with oral iron for 28 days and morbidity was monitored through surveillance at health centres. The primary endpoint was the proportion of children with moderate or severe anaemia at the end of the transmission season. Secondary endpoints included the incidence of clinical episodes of malaria during the surveillance period, outpatient attendances, the prevalence of parasitaemia and splenomegaly, nutritional status at the end of the malaria transmission season and compliance with the treatment regimen.


RESULTS
The proportions of children with a Hb concentration of <7 g/dL at the end of the malaria transmission season were similar in the two study groups, 14/464 (3.0%) in children who received at least one dose of SP and 16/471 (3.4%) in those who received placebo, prevalence ratio 0.89 (0.44,1.8) P = 0.742. The protective efficacy of SP against episodes of clinical malaria was 53% (95% CI 37%, 65%). Treatment with SP was safe and well tolerated; no serious adverse events related to SP administration were observed. Mortality following discharge from hospital was low among children who received SP or placebo (6 in the SP group and 9 in the placebo group respectively).


CONCLUSIONS
Intermittent treatment with SP did not reduce the proportion of previously anaemic children with moderate or severe anaemia at the end of the malaria season, although it prevented malaria. The combination of appropriate antimalarial treatment plus one month of iron supplementation and good access to healthcare during follow-up proved effective in restoring haemoglobin to an acceptable level in the Gambian setting.


BACKGROUND
ClinicalTrials.gov NCT00131716.
Bojang
Kalifa A
KA
Medical Research Council Laboratories, Banjul, The Gambia. kbojang@mrc.gm
Milligan
Paul J M
PJ
Conway
David J
DJ
Sisay-Joof
Fatou
F
Jallow
Muminatou
M
Nwakanma
Davis C
DC
Abubakr
Ismaela
I
Njie
Fanta
F
Greenwood
Brian
B
D000740:Anemia / Q000517:prevention & control*; D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology; D004338:Drug Combinations; D004351:Drug Resistance / Q000235:genetics; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005714:Gambia; D005819:Genetic Markers / Q000235:genetics; D005838:Genotype; D006761:Hospitals; D006801:Humans; D008288:Malaria / Q000517:prevention & control / Q000635:transmission; D008297:Male; D009752:Nutritional Status / Q000187:drug effects; D010271:Parasites / Q000187:drug effects / Q000235:genetics / Q000502:physiology; D010349:Patient Compliance; D010351:Patient Discharge; D011739:Pyrimethamine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D055502:Secondary Prevention; D013413:Sulfadoxine / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*
D000962:Antimalarials; D004338:Drug Combinations; D005819:Genetic Markers; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine