Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled trial.
BACKGROUND
Intermittent preventive treatment aims to maximize the protective effects of malaria chemoprophylaxis while minimizing the deleterious effects.


METHODS
In Gabon, 1189 infants received either sulfadoxine-pyrimethamine (SP; 250 and 12.5 mg, respectively) or placebo at 3, 9, and 15 months of age. Children were actively followed-up until 18 months of age.


RESULTS
In the intention-to-treat population at 18 months of follow-up, 84 children (17%) in the SP group had > or =1 episode of anemia, versus 108 (21%) in the placebo group (protective efficacy, 22% [95% confidence interval {CI}, -1% to 40%]; P=.06). In the intervention group, there were 66 episodes during 485 person-years at risk, compared with 79 episodes during 497 years in the placebo group (protective efficacy, 17% [95% CI, -24% to 45%; P=.36). The effects were similar at 12 months of follow-up. The study drug was safe and well tolerated.


CONCLUSIONS
The intervention was efficacious, producing a reduction in risk for anemia but a smaller effect against malaria. It is a valuable additional tool to control malaria in a highly vulnerable age group. Remaining important questions are currently being addressed in further studies.


BACKGROUND
ClinicalTrials.gov identifier: NCT00167843.
Grobusch
Martin P
MP
Medical Research Unit, Albert Schweitzer Hospital, Lambarene, Gabon. martin.grobusch@wits.ac.za
Lell
Bertrand
B
Schwarz
Norbert G
NG
Gabor
Julian
J
Dornemann
Jenny
J
Potschke
Marc
M
Oyakhirome
Sunny
S
Kiessling
Georg C
GC
Necek
Magdalena
M
Langin
Matthias U
MU
Klein Klouwenberg
Peter
P
Klopfer
Anna
A
Naumann
Benjamin
B
Altun
Handan
H
Agnandji
Selidji T
ST
Goesch
Julia
J
Decker
Marieluise
M
Salazar
Carmen L Ospina
CL
Supan
Christian
C
Kombila
Davy U
DU
Borchert
Lea
L
Koster
Kai B
KB
Pongratz
Peter
P
Adegnika
Akim A
AA
Glasenapp
Isabelle von
Iv
Issifou
Saadou
S
Kremsner
Peter G
PG
D000740:Anemia / Q000139:chemically induced / Q000453:epidemiology; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005681:Gabon / Q000453:epidemiology; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D015994:Incidence; D007223:Infant; D053208:Kaplan-Meier Estimate; D016778:Malaria, Falciparum / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D018512:Parasitemia / Q000097:blood / Q000453:epidemiology / Q000469:parasitology / Q000517:prevention & control*; D018579:Patient Selection; D011739:Pyrimethamine / Q000008:administration & dosage* / Q000009:adverse effects; D012107:Research Design; D013413:Sulfadoxine / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000962:Antimalarials; D004338:Drug Combinations; D006454:Hemoglobins; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine