PMID- 16826474
OWN - NLM
STAT- MEDLINE
DCOM- 20071127
LR  - 20131121
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Linking)
VI  - 194
IP  - 3
DP  - 2006 Aug 1
TI  - Intermittent preventive treatment for malaria control administered at the time of 
      routine vaccinations in Mozambican infants: a randomized, placebo-controlled 
      trial.
PG  - 276-85
AB  - BACKGROUND: There is an urgent need to deploy and develop new control tools that 
      will reduce the intolerable burden of malaria. Intermittent preventive treatment 
      in infants (IPTi) has the potential to become an effective tool for malaria 
      control. METHODS: We performed a randomized, double-blind, placebo-controlled 
      trial of sulfadoxine-pyrimethamine (SP) treatment in 1503 Mozambican children. 
      Doses of SP or placebo were given at 3, 4, and 9 months of age. The intervention 
      was administered alongside routine vaccinations delivered through the Expanded 
      Program on Immunization (EPI). Hematological and biochemical tests were done when 
      infants were 5 months old. Morbidity monitoring through a hospital-based passive 
      case-detection system was complemented by cross-sectional surveys when infants 
      were 12 and 24 months old. RESULTS: IPTi was well tolerated, and no adverse 
      events associated with SP were documented. During the first year of life, 
      intermittent SP treatment reduced the incidence of clinical malaria by 22.2% (95% 
      confidence interval [CI], 3.7%-37.0%; P=.020) and the rate of hospital admissions 
      by 19% (95% CI, 4.0%-31.0%; P=.014). Although the incidence of severe anemia 
      (packed cell volume of <25%) did not differ significantly between the 2 groups 
      (protective effect, 12.7% [95% CI, -17.3% to 35.1%]; P=.36), there was a 
      significant reduction in hospital admissions for anemia during the month after 
      dosing for both the first and second dose. The serological responses to EPI 
      vaccines were not modified by the intervention. CONCLUSIONS: IPTi with SP has 
      been shown to moderately reduce the incidence of clinical malaria in Mozambican 
      infants without evidence of rebound after stopping the intervention or of 
      interactions with EPI vaccines. Its recommendation as a malaria control strategy 
      in Mozambique needs to be balanced against the scarcity of affordable control 
      tools and the burden of malaria in children.
FAU - Macete, Eusebio
AU  - Macete E
AD  - Manhica Health Research Center, Manhica, Mozambique.
FAU - Aide, Pedro
AU  - Aide P
FAU - Aponte, John J
AU  - Aponte JJ
FAU - Sanz, Sergi
AU  - Sanz S
FAU - Mandomando, Inacio
AU  - Mandomando I
FAU - Espasa, Mateu
AU  - Espasa M
FAU - Sigauque, Betuel
AU  - Sigauque B
FAU - Dobano, Carlota
AU  - Dobano C
FAU - Mabunda, Samuel
AU  - Mabunda S
FAU - DgeDge, Martinho
AU  - DgeDge M
FAU - Alonso, Pedro
AU  - Alonso P
FAU - Menendez, Clara
AU  - Menendez C
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20060630
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antimalarials)
RN  - 0 (Drug Combinations)
RN  - 0 (Placebos)
RN  - 37338-39-9 (fanasil, pyrimethamine drug combination)
RN  - 88463U4SM5 (Sulfadoxine)
RN  - Z3614QOX8W (Pyrimethamine)
SB  - IM
CIN - J Infect Dis. 2006 Aug 1;194(3):269-72. PMID: 16826472
MH  - Animals
MH  - Antimalarials/*administration & dosage/adverse effects
MH  - Chemoprevention
MH  - Child, Preschool
MH  - Cross-Sectional Studies
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Infant
MH  - Malaria, Falciparum/drug therapy/parasitology/*prevention & control
MH  - Male
MH  - Placebos
MH  - Plasmodium falciparum/growth & development
MH  - Pyrimethamine/*administration & dosage/adverse effects
MH  - Sulfadoxine/*administration & dosage/adverse effects
EDAT- 2006/07/11 09:00
MHDA- 2007/12/06 09:00
CRDT- 2006/07/11 09:00
PHST- 2005/12/13 00:00 [received]
PHST- 2006/02/14 00:00 [accepted]
PHST- 2006/07/11 09:00 [pubmed]
PHST- 2007/12/06 09:00 [medline]
PHST- 2006/07/11 09:00 [entrez]
AID - JID36085 [pii]
AID - 10.1086/505431 [doi]
PST - ppublish
SO  - J Infect Dis. 2006 Aug 1;194(3):276-85. doi: 10.1086/505431. Epub 2006 Jun 30.