Zinc Pneumonia Outpatient Trial in Children < 2 Years

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Thrasher Research Fund
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00142285
First received: September 1, 2005
Last updated: January 6, 2013
Last verified: July 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Zinc in the Treatment of Outpatient Pneumonia in an Urban Slum Among Children Less Than 2 Years Old

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Duration of illness
  • Treatment failure

Secondary Outcome Measures:
  • Incidence of subsequent illness episodes (pneumonia and any other)

Estimated Enrollment: 2260
Study Start Date: November 2004
Study Completion Date: May 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of pneumonia

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00142285

Locations
Bangladesh
Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research
Dhaka, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Thrasher Research Fund
Investigators
Principal Investigator: W. Abdullah Brooks, MD, MPH ICDDR,B: Centre for Health & Population Research
  More Information

Additional Information:
Publications:
Responsible Party: Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00142285     History of Changes
Other Study ID Numbers: ICDDR,B 2004-010
Study First Received: September 1, 2005
Last Updated: January 6, 2013
Health Authority: Bangladesh: Directorate of Drug Administration
Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
pneumonia
zinc
treatment
efficacy
children

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Astringents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014