Enhanced community case management to increase access to pneumonia treatment

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12617000857303
• Date of registration: 09/06/2017
• Prospective Registration: No
• Primary sponsor: World Health Organization
• Public title: Enhanced community case management to increase access to pneumonia treatment
• Scientific title: Enhanced community case management to increase access to pneumonia treatment in children under 5 years of age in sub-Saharan Africa and South Asia
• Date of first enrolment: 16/09/2016
• Target sample size: 4700
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617000857303.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Bangladesh, Ethiopia, India, Malawi

Contacts

• Name: Dr Shamim Ahmad Qazi

• Name: Dr Shamim Ahmad Qazi

Key inclusion & exclusion criteria

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.

Age minimum: 7 Days
Age maximum: 59 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Acute respiratory infections;Pneumonia;
Acute respiratory infections
Pneumonia

Infection - Other infectious diseases

Respiratory - Other respiratory disorders / diseases

Intervention(s)

In a cluster randomised controlled trial (RCT), in addition to standard Integrated Community Case Mangement (iCCM), (i) young infants 7 to 59 days of age with fast breathing without hypoxaemia and (ii) children 2-59 months of age with chest indrawing without hypoxaemia will be managed by Community Level Health Workers (CLHWs) with oral amoxicillin, 90 mg/kg/day divided into two doses. For this study oral dispersible amoxicillin in 250 mg scored tablets will be used for both age groups. The dispersible tablets would have to be dispersed in clean water and in expressed breast milk for exclusively breastfed young infants. The WHO recommends 5 days of amoxicillin for chest indrawing pneumonia. For young infants less than two months 7 days therapy will be used. The trial strategy will enhance the existing standard iCCM, which currently recommends referral to hospital for these children. Access to pneumonia treatment will be increased to many children whose families cannot access treatment at hospitals due to various reasons. The proposed intervention is to train CLHWs and maintain their skills to manage infants with fast breathing and children with chest indrawing. Commodities including dispensible amoxicillin tables 250 mg, pulse oximeters, and ARI timers will be regularly provided. All enrolled children will be followed up for up to two weeks and their outcomes will be documented by independent assessors.

Before the commencement of original enrolment, 6-8 days standard and enhanced iCCM training will be given to CLHWs in control and intervention clusters, respectively. In standard iCCM training group, CLHWs will be trained on current WHO/UNICEF iCCM. In enhanced iCCM training group, CLHWs will be trained to provide treatment with oral amoxicillin either for 7 days in case of young infants <2 months of age with fast breathing (>=60 breaths per minute) or for 5 days in case of children 2-59 months of age with lower chest indrawing pneumonia. Further, CLHWs will al

Primary Outcome(s)

Treatment failure rate within day 1-6 of enrolment will be the primary outcome.

Definition of treatment failure
1. Death at any time within day 1 to day 6 of enrolment (and 7-14 days as secondary outcome).
2. Child hospitalised for any reason or has any indication of hospitalisation on day 6.
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.
4. Development of serious adverse effect of the study antibiotics (anaphylactic reaction, severe diarrhoea, disseminated and severe rash).

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.
[Primary outcome will be assessed at day 6 and for deaths also at day 14 after enrolment.]

Secondary Outcome(s)

Evaluating the feasibility of using a pulse oximeter by CLHWs.
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.
[This will be a continuous process to capture information about the feasibility of using a pulse oximeter by CLHW throughout the trial duration. ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Bill and Melinda Gates Foundation

Ethics review

Status: Approved
Approval date:
Contact:

WHO ERC