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

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

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.

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

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

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

Study chairs or principal investigators

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

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