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

University of North Carolina, Chapel Hill1,280 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,280

Conditions

Respiratory Infections in Children

Interventions

STAR Sick Child Job AidOTHER

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Bugoye Health Center III

Bugoye, Kasese District, Uganda

Outcomes

Primary Outcomes

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.

Time frame: Baseline visit

Secondary Outcomes

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.

Time frame: Between baseline visit and Day 7 follow-up assessment

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.

Time frame: Between baseline visit and Day 7 follow-up assessment

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.

Time frame: Day 7

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.

Time frame: Day 7

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.

Data from ClinicalTrials.gov

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