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Completed

NCT Number: NCT05294510

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

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.

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Key information

Conditions

Respiratory Infections in Children

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bugoye Health Center III

Bugoye, Kasese District, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAR Sick Child Job Aid

Other

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.

Primary outcomes

  1. Antibiotic prescriptions at baseline visit

    Time frame: 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 outcomes

  1. Clinical Failure (Composite Outcome)

    Time frame: 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.

  2. Unexpected visits

    Time frame: 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.

  3. Perceived improvement per caregiver

    Time frame: 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.

  4. Persistent fever

    Time frame: 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.

  5. Development of danger signs

    Time frame: 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.

  6. Hospitalization

    Time frame: 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.

  7. Death

    Time frame: 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.

  8. Antibiotic prescriptions during study follow-up

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

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

Acronym: STAR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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