PMID- 22208409
OWN - NLM
STAT- MEDLINE
DCOM- 20120315
LR  - 20220311
IS  - 1475-2875 (Electronic)
IS  - 1475-2875 (Linking)
VI  - 10
DP  - 2011 Dec 30
TI  - Cluster-randomized study of intermittent preventive treatment for malaria in 
      infants (IPTi) in southern Tanzania: evaluation of impact on survival.
PG  - 387
LID - 10.1186/1475-2875-10-387 [doi]
AB  - BACKGROUND: Intermittent Preventive Treatment for malaria control in infants 
      (IPTi) consists of the administration of a treatment dose of an anti-malarial 
      drug, usually sulphadoxine-pyrimethamine, at scheduled intervals, regardless of 
      the presence of Plasmodium falciparum infection. A pooled analysis of 
      individually randomized trials reported that IPTi reduced clinical episodes by 
      30%. This study evaluated the effect of IPTi on child survival in the context of 
      a five-district implementation project in southern Tanzania. [ TRIAL 
      REGISTRATION: clinicaltrials.gov NCT00152204]. METHODS: After baseline household 
      and health facility surveys in 2004, five districts comprising 24 divisions were 
      randomly assigned either to receive IPTi (n = 12) or not (n = 12). Implementation 
      started in March 2005, led by routine health services with support from the 
      research team. In 2007, a large household survey was undertaken to assess the 
      impact of IPTi on survival in infants aged two-11 months through birth history 
      interviews with all women aged 13-49 years. The analysis is based on an 
      "intention-to-treat" ecological design, with survival outcomes analysed according 
      to the cluster in which the mothers lived. RESULTS: Survival in infants aged 
      two-11 months was comparable in IPTi and comparison areas at baseline. In 
      intervention areas in 2007, 48% of children aged 12-23 months had documented 
      evidence of receiving three doses of IPTi, compared to 2% in comparison areas (P 
      < 0.0001). Over the three years of the study there was a marked improvement in 
      survival in both groups. Between 2001-4 and 2005-7, mortality rates in two-11 
      month olds fell from 34.1 to 23.6 per 1,000 person-years in intervention areas 
      and from 32.3 to 20.7 in comparison areas. In 2007, divisions implementing IPTi 
      had a 14% (95% CI -12%, 49%) higher mortality rate in two-11 month olds in 
      comparison with non-implementing divisions (P = 0.31). CONCLUSION: The lack of 
      evidence of an effect of IPTi on survival could be a false negative result due to 
      a lack of power or imbalance of unmeasured confounders. Alternatively, there 
      could be no mortality impact of IPTi due to low coverage, late administration, 
      drug resistance, decreased malaria transmission or improvements in vector control 
      and case management. This study raises important questions for programme 
      evaluation design.
FAU - Schellenberg, Joanna R M Armstrong
AU  - Schellenberg JR
AD  - London School of Hygiene and Tropical Medicine, London, UK. 
      Joanna.schellenberg@lshtm.ac.uk
FAU - Maokola, Werner
AU  - Maokola W
FAU - Shirima, Kizito
AU  - Shirima K
FAU - Manzi, Fatuma
AU  - Manzi F
FAU - Mrisho, Mwifadhi
AU  - Mrisho M
FAU - Mushi, Adiel
AU  - Mushi A
FAU - Alonso, Pedro
AU  - Alonso P
FAU - Mshinda, Hassan
AU  - Mshinda H
FAU - Tanner, Marcel
AU  - Tanner M
FAU - Schellenberg, David M
AU  - Schellenberg DM
LA  - eng
SI  - ClinicalTrials.gov/NCT00152204
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111230
PL  - England
TA  - Malar J
JT  - Malaria journal
JID - 101139802
RN  - 0 (Antimalarials)
RN  - 0 (Drug Combinations)
RN  - 37338-39-9 (fanasil, pyrimethamine drug combination)
RN  - 88463U4SM5 (Sulfadoxine)
RN  - Z3614QOX8W (Pyrimethamine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antimalarials/*administration & dosage
MH  - Drug Combinations
MH  - Drug Therapy/*methods
MH  - Female
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Malaria, Falciparum/*drug therapy/mortality/*prevention & control
MH  - Middle Aged
MH  - Pregnancy
MH  - Pyrimethamine/administration & dosage
MH  - Sulfadoxine/administration & dosage
MH  - Survival Analysis
MH  - Tanzania
MH  - Young Adult
PMC - PMC3261134
EDAT- 2012/01/03 06:00
MHDA- 2012/03/16 06:00
PMCR- 2011/12/30
CRDT- 2012/01/03 06:00
PHST- 2011/07/26 00:00 [received]
PHST- 2011/12/30 00:00 [accepted]
PHST- 2012/01/03 06:00 [entrez]
PHST- 2012/01/03 06:00 [pubmed]
PHST- 2012/03/16 06:00 [medline]
PHST- 2011/12/30 00:00 [pmc-release]
AID - 1475-2875-10-387 [pii]
AID - 10.1186/1475-2875-10-387 [doi]
PST - epublish
SO  - Malar J. 2011 Dec 30;10:387. doi: 10.1186/1475-2875-10-387.