Clinical Trial: Zinc Pneumonia Outpatient Trial in Children < 2 Years

This study is currently recruiting patients.
Verified by International Centre for Diarrhoeal Disease Research, Bangladesh September 2005

Sponsors and Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Thrasher Research Fund
Information provided by: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00142285

Purpose

The purpose of this study is to determine whether zinc can be used in combination with standard antibiotics to reduce the duration of illness and the likelihood of treatment failure among children less than two years old who have non-severe, outpatient pneumonia.
Condition Intervention Phase
Pneumonia
 Drug: Zinc sulphate (20 mg)
Phase III

MedlinePlus related topics:  Pneumonia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Efficacy of Zinc in the Treatment of Outpatient Pneumonia in an Urban Slum Among Children Less Than 2 Years Old

Further Study Details: 
Primary Outcomes: Duration of illness; Treatment failure
Secondary Outcomes: Incidence of subsequent illness episodes (pneumonia and any other)
Expected Total Enrollment:  2260

Study start: November 2004;  Expected completion: June 2007
Last follow-up: October 2006;  Data entry closure: January 2007

This study is a follow up to an earlier study among hospitalised children less than two years old with severe pneumonia who were administered zinc as an adjuvant along with standard antimicrobial agents. That study found a 20% reduction in illness duration and hospitalisation, as well as a 3 – 9 fold reduction in treatment failure for children given zinc along with standard antimicrobial management. However, since most pneumonia is managed in an outpatient setting, it is important to know if it works in this setting as well. We hypothesise that zinc may act as an acute phase reactant in the early stages of outpatient non-severe pneumonia to reduce both the duration of illness and the likelihood of treatment failure.

To test this, we will randomise children less than two years old to receive either zinc or placebo can as an adjuvant to standard oral antimicrobial agents in the acute treatment of non-severe pneumonia in an outpatient urban setting. Oral antibiotics will be given for a standard five-day course, while zinc (20 mg) or placebo will be administered once-daily for 10 days. Patients will be followed up on a daily basis at home to monitor their progress and document compliance.

Outcomes will be a comparison between zinc and placebo groups on duration of illness, as measured by specific signs of pneumonia, and treatment failure, as measured by change of antibiotics or hospitalisation for failure to improve or worsening condition.

Eligibility

Ages Eligible for Study:  up to  23 Months,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Wheezing at presentation History of chronic lung, heart or other system disease suspected tuberculosis, active measles, severe malnutrition requiring hospitalisation, signs of systemic illness (sepsis, meningitis), those who have already received zinc/placebo supplements during this study, those known to be pre-treated with antibiotics prior to presenting to clinic

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00142285

W. Abdullah Brooks, MD, MPH      88 02 9881662    abrooks@icddrb.org
Dilruba Nasrin, MBBS, PhD      88 02 9881662    dnasrin@icddrb.org

Bangladesh
      Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research, Dhaka,  Bangladesh; Recruiting
Bejoy R Saha, MBA  88 02 8810117    brsaha@icddrb.org 
W. Abdullah Brooks, MD, MPH,  Principal Investigator
Dilruba Nasrin, MBBS, PhD,  Sub-Investigator

Study chairs or principal investigators

W. Abdullah Brooks, MD, MPH,  Principal Investigator,  ICDDR,B: Centre for Health & Population Research   

More Information

Publications

Brooks WA, Yunus M, Santosham M, Wahed MA, Nahar K, Yeasmin S, Black RE. Zinc for severe pneumonia in very young children: double-blind placebo-controlled trial. Lancet. 2004 May 22;363(9422):1683-8.

Study ID Numbers:  ICDDR,B 2004-010
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00142285
Health Authority: Bangladesh: Directorate of Drug Administration; Bangladesh: Ethical Review Committee
ClinicalTrials.gov processed this record on 2005-09-06

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