NCT05294510

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

STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,280 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 2 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Infections in Children

Interventions

Type	Name	Description
OTHER	STAR Sick Child Job Aid	The STAR Sick Child Job Aid is a modified ICCM protocol that includes the addition of a point-of-care C-reactive protein (CRP) test to inform antibiotic treatment decisions for children presenting with febrile acute respiratory illness who do not have any danger signs. If CRP ≥ 40 mg/L, the village health worker (VHW) will dispense amoxicillin per local guidelines. If CRP \< 40 mg/L, the VHW will advise symptomatic care alone including acetaminophen for fever and additional fluids to maintain hydration.

Timeline

• Start date: 2021-11-02
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2022-03-24
• Last updated: 2022-08-04

Locations

1 site across 1 country: Uganda