Improving Antibiotic Stewardship for Children With Respiratory Illness Presenting to Village Health Workers in Uganda (STAR)

University of North Carolina (UNC)

Status: Completed

Conditions: Respiratory Infections in Children

Treatments: Other: STAR Sick Child Job Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT05294510

15206 (Other Grant/Funding Number)

18-2803

Details and patient eligibility

About

This is a stepped wedge, cluster randomized study of a clinical algorithm that includes point-of-care C-reactive protein testing to inform antibiotic treatment decisions by village health workers for children presenting with acute respiratory illness in the Bugoye sub-county of the Kasese District in southwestern Uganda.

The purpose of this study is to assess the impact of the algorithm on antibiotic use.

Enrollment: 1,280 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 2 months-5 years
• Evaluated by a study VHW in one of the participating villages in Bugoye sub-county for acute respiratory illness defined as the following: fever (documented (temperature > 38°C) or subjective fever in the last seven days) AND fast breathing (respiratory rate > 30) OR cough

Exclusion criteria

• Age > 5 years or < 2 months at time of presentation
• Guardian not present to provide consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,280 participants in 2 patient groups

Control

No Intervention group

Description:

Children who present to a village health worker during a control period are evaluated and managed using the current standard of care per Uganda National Guidelines for Integrated Community Case Management (ICCM). Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design.

Intervention

Experimental group

Description:

Children who present to a village health worker during an intervention period are evaluated and managed using a modified ICCM algorithm that includes point-of-care C-reactive protein testing. Each village will experience both Control and Intervention conditions as the study employs a stepped wedge design.

Treatment:

Other: STAR Sick Child Job Aid