Enhanced community case management to increase access to pneumonia treatment

Phase 3

Recruiting

• Conditions: Acute respiratory infections; Pneumonia; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12617000857303
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-09
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4700

Inclusion Criteria

In selective districts in Bangladesh, Ethiopia, India and Malawi, first level health facilities (with catchment population of 10,000 to 25,000 each) will be randomised either to control or intervention arm. All CLHWs attached to the first level health facility will provide treatmentment to the following children based on intervention status (control or intervention):
- 7-59 days old infants in intervention or control clusters who develop fast breathing (respiratory rate >60 breaths per min).
- 2-59 month old children infants in intervention or control clusters who develop chest indrawing pneumonia.

Exclusion Criteria

7-59 days old infants in intervention and control cluster who develop severe chest indrawing or danger signs or fast breathing in <7 days old young infants and if consent not provided for enrolment for eligible young infants.
2-59 month old children infants in intervention or control clusters who develop danger signs or if consent not provided for enrolment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure rate within day 1-6 of enrolment will be the primary outcome.<br><br>Definition of treatment failure<br>1.Death at any time within day 1 to day 6 of enrolment (and 7-14 days as secondary outcome).<br>2.Child hospitalised for any reason or has any indication of hospitalisation on day 6. <br>3. Persistence of fast breathing in young infants 7-59 days of age or persistence of chest indrawing in children 2-59 months of age on day 6 of enrolment.<br>4.Development of serious adverse effect of the study antibiotics (anaphylactic reaction, severe diarrhoea, disseminated and severe rash).<br><br>Outcome will be assessed by independent outcome assessors (nurses) which will be hired and trained to evaluate children on day 6 for primary outcome measure and on day 14 for secondary outcome measure. <br>[Primary outcome will be assessed at day 6 and for deaths also at day 14 after enrolment.]

Secondary Outcome Measures

Name	Time	Method
Evaluating the feasibility of using a pulse oximeter by CLHWs. <br>We will use indepth qualitative interviews and structure observations to evaluate the feasibility of using a pulse oximeter by CLHWs. In all intervention clusters CLHWs will use pulse oximeter to measure oxygen saturation in young infants <2 months of age with fast breathing and children 2-59 months of age with lower chest indrawing. <br>[This will be a continuous process to capture information about the feasibility of using a pulse oximeter by CLHW throughout the trial duration. ]