title: Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled trial.
abstract: 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.
authors.affiliation: Medical Research Unit, Albert Schweitzer Hospital, Lambarene, Gabon. martin.grobusch@wits.ac.za
authors.forename: Martin P
authors.initials: MP
authors.lastname: Grobusch
authors.forename: Bertrand
authors.initials: B
authors.lastname: Lell
authors.forename: Norbert G
authors.initials: NG
authors.lastname: Schwarz
authors.forename: Julian
authors.initials: J
authors.lastname: Gabor
authors.forename: Jenny
authors.initials: J
authors.lastname: Dornemann
authors.forename: Marc
authors.initials: M
authors.lastname: Potschke
authors.forename: Sunny
authors.initials: S
authors.lastname: Oyakhirome
authors.forename: Georg C
authors.initials: GC
authors.lastname: Kiessling
authors.forename: Magdalena
authors.initials: M
authors.lastname: Necek
authors.forename: Matthias U
authors.initials: MU
authors.lastname: Langin
authors.forename: Peter
authors.initials: P
authors.lastname: Klein Klouwenberg
authors.forename: Anna
authors.initials: A
authors.lastname: Klopfer
authors.forename: Benjamin
authors.initials: B
authors.lastname: Naumann
authors.forename: Handan
authors.initials: H
authors.lastname: Altun
authors.forename: Selidji T
authors.initials: ST
authors.lastname: Agnandji
authors.forename: Julia
authors.initials: J
authors.lastname: Goesch
authors.forename: Marieluise
authors.initials: M
authors.lastname: Decker
authors.forename: Carmen L Ospina
authors.initials: CL
authors.lastname: Salazar
authors.forename: Christian
authors.initials: C
authors.lastname: Supan
authors.forename: Davy U
authors.initials: DU
authors.lastname: Kombila
authors.forename: Lea
authors.initials: L
authors.lastname: Borchert
authors.forename: Kai B
authors.initials: KB
authors.lastname: Koster
authors.forename: Peter
authors.initials: P
authors.lastname: Pongratz
authors.forename: Akim A
authors.initials: AA
authors.lastname: Adegnika
authors.forename: Isabelle von
authors.initials: Iv
authors.lastname: Glasenapp
authors.forename: Saadou
authors.initials: S
authors.lastname: Issifou
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
mesh_terms: 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
chemical_list: D000962:Antimalarials; D004338:Drug Combinations; D006454:Hemoglobins; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D011739:Pyrimethamine