Document Detail


Zinc as adjunct treatment in infants aged between 7 and 120 days with probable serious bacterial infection: a randomised, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  22656335     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Serious bacterial infections are a major cause of death in early infancy in developing countries. Inexpensive and accessible interventions that can add to the effect of standard antibiotic treatment could reduce infant mortality. We measured the effect of zinc as an adjunct to antibiotics in infants with probable serious bacterial infection.
METHODS: In this randomised, double-blind, placebo-controlled trial, we enrolled infants aged 7-120 days with probable serious bacterial infection at three hospitals in New Delhi, India, between July 6, 2005, and Dec 3, 2008. With computer-generated sequences, we randomly assigned infants in permuted blocks of six, stratified by whether patients were underweight or had diarrhoea at enrolment, to receive either 10 mg of zinc or placebo orally every day in addition to standard antibiotic treatment. The primary outcome was treatment failure, which was defined as a need to change antibiotics within 7 days of randomisation, or a need for intensive care, or death at any time within 21 days. Participants and investigators were masked to treatment allocation. All analyses were done by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00347386.
FINDINGS: 352 infants were randomly assigned to receive zinc and 348 to placebo. 332 given zinc and 323 given placebo could be assessed for treatment failure. Significantly fewer treatment failures occurred in the zinc group (34 [10%]) than in the placebo group (55 [17%]; relative risk reduction 40%, 95% CI 10-60, p=0·0113; absolute risk reduction 6·8%, 1·5-12·0, p=0·0111). Treatment of 15 (95% CI eight to 67) infants with zinc would prevent one treatment failure. Ten infants receiving zinc died compared with 17 given placebo (relative risk 0·57, 0·27-1·23, p=0·15).
INTERPRETATION: Zinc could be given as adjunct treatment to reduce the risk of treatment failure in infants aged 7-120 days with probable serious bacterial infection.
FUNDING: Department of Biotechnology, Government of India; the European Commission; the Meltzer Foundation; and the Research Council of Norway.
Authors:
Shinjini Bhatnagar; Nitya Wadhwa; Satinder Aneja; Rakesh Lodha; Sushil Kumar Kabra; Uma Chandra Mouli Natchu; Halvor Sommerfelt; Ashok Kumar Dutta; Jagdish Chandra; Bimbadhar Rath; Mamta Sharma; Vinod Kumar Sharma; Mohini Kumari; Tor A Strand
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  379     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-06-04     Completed Date:  2012-07-17     Revised Date:  2013-07-01    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  2072-8     Citation Subset:  AIM; IM    
Affiliation:
Centre for Diarrhoeal Diseasesand Nutrition Research, All IndiaInstitute of Medical Sciences, New Delhi, India. shinjini.bhatnagar@thsti.res.in
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00347386
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Anti-Bacterial Agents / therapeutic use
Bacterial Infections / complications,  diagnosis,  drug therapy*
Body Weight
Diarrhea, Infantile / drug therapy,  microbiology
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Infant
Infant, Newborn
Male
Trace Elements / administration & dosage,  therapeutic use
Treatment Failure
Weight Gain / drug effects
Zinc / administration & dosage,  therapeutic use*
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Trace Elements; 7440-66-6/Zinc
Comments/Corrections
Comment In:
Lancet. 2012 Jun 2;379(9831):2031-3   [PMID:  22656334 ]
Lancet. 2012 Sep 29;380(9848):1143-4; author reply 1144   [PMID:  23021277 ]
Lancet. 2012 Sep 29;380(9848):1143; author reply 1144   [PMID:  23021276 ]
Lancet. 2012 Sep 29;380(9848):1143; author reply 1144   [PMID:  23021275 ]
Evid Based Med. 2013 Jun;18(3):e22   [PMID:  23086564 ]

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