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

Respiratory Infections in Children Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294510
• Other study ID #: 18-2803
• Secondary ID: 15206
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Infections in Children
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Uganda	Bugoye Health Center III	Bugoye	Kasese District

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Thrasher Research Fund

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic prescriptions at 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.	Baseline visit
Secondary	Clinical Failure (Composite Outcome)	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.	Between baseline visit and Day 7 follow-up assessment
Secondary	Unexpected visits	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.	Between baseline visit and Day 7 follow-up assessment
Secondary	Perceived improvement per caregiver	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.	Day 7
Secondary	Persistent fever	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.	Day 7
Secondary	Development of danger signs	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.	Between Day 1 and Day 7
Secondary	Hospitalization	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.	Between Day 1 and Day 7
Secondary	Death	Proportion of children who die during the seven-day follow-up period in the control as compared to intervention periods.	Between Day 1 and Day 7
Secondary	Antibiotic prescriptions during study follow-up	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.	Between baseline visit and Day 7 follow-up assessment