NCT00142285

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,260

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 11, 2022

Status Verified

July 1, 2006

Enrollment Period

1.5 years

First QC Date

September 1, 2005

Last Update Submit

February 10, 2022

Conditions

Pneumonia

Keywords

pneumoniazinctreatmentefficacychildren

Outcome Measures

Primary Outcomes (2)

  • Duration of illness

  • Treatment failure

Secondary Outcomes (1)

  • Incidence of subsequent illness episodes (pneumonia and any other)

Interventions

Zinc sulphate (20 mg)DRUG

Eligibility Criteria

Age1 Week - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of pneumonia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kamalapur Urban Site, ICDDR,B: Centre for Health & Population Research

Dhaka, Bangladesh

Location

Related Publications (1)

  • 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. doi: 10.1016/S0140-6736(04)16252-1.

    PMID: 15158629BACKGROUND

Related Links

MeSH Terms

Conditions

Pneumonia

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsInorganic ChemicalsZinc Compounds

Study Officials

  • W. Abdullah Brooks, MD, MPH

    ICDDR,B: Centre for Health & Population Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

November 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2008

Last Updated

February 11, 2022

Record last verified: 2006-07

Locations

BA(1)