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

Not Applicable

Completed

• Conditions: Respiratory Infections in Children
• Interventions: Other: STAR Sick Child Job Aid

• Registration Number: NCT05294510
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-02
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1280

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	STAR Sick Child Job Aid	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.

Primary Outcome Measures

Name	Time	Method
Antibiotic prescriptions at baseline visit	Baseline visit	Proportion of children prescribed antibiotics by the village health worker at the baseline visit in the control as compared to the intervention condition.

Secondary Outcome Measures

Name	Time	Method
Unexpected visits	Between baseline visit and Day 7 follow-up assessment	Proportion of children brought to the village health worker during the seven-day follow-up period for persistent or worsening symptoms by their caregiver in the control as compared to the intervention condition.
Perceived improvement per caregiver	Day 7	Proportion of caregivers who perceive that their child has clinically improved at the Day 7 follow-up assessment in the control as compared to the intervention condition.
Clinical Failure (Composite Outcome)	Between baseline visit and Day 7 follow-up assessment	Proportion of children with one or more of the following outcomes in the control as compared to the intervention condition: persistence of fever at Day 7, development of danger signs as defined by local Integrated Community Care Management guidelines at any time during the seven-day follow-up period, need for hospitalization at any time during follow-up period, or death at any time during follow-up period.
Persistent fever	Day 7	Proportion of children who have persistence of subjective or documented fever at the Day 7 follow-up assessment in the control as compared to the intervention condition.
Development of danger signs	Between Day 1 and Day 7	Proportion of children who develop danger signs (as defined by local Integrated Community Care Management guidelines) during the seven-day follow-up period in the control as compared to intervention conditions.
Hospitalization	Between Day 1 and Day 7	Proportion of children who require inpatient admission to a health facility during the seven-day follow-up period in the control as compared to intervention periods.
Death	Between Day 1 and Day 7	Proportion of children who die during the seven-day follow-up period in the control as compared to intervention periods.
Antibiotic prescriptions during study follow-up	Between baseline visit and Day 7 follow-up assessment	Proportion of children prescribed antibiotics by any provider either at the baseline visit or during the seven-day follow-up period in the control as compared to the intervention condition.

Trial Locations

Locations (1)

Bugoye Health Center III; 🇺🇬 Bugoye, Kasese District, Uganda