Clinical trial NCT05294510: Improving Antibiotic Stewardship for Children With Respiratory Illness Presenting to Village Health Workers in Uganda
Official title: STewardship for Acute Respiratory Illness (STAR): a Stepped Wedge, Cluster Randomized Trial of Point-of-care Biomarker Testing by Village Health Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infections in Children
Keywords: Community health workers
C-reactive protein
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2022-03-24
Enrollment: 1280
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge, cluster randomized trial with 5 clusters or treatment sequences of 3 villages each. Villages are first stratified by altitude, proximity to the local health center, and size (based on approximate number of children seen by the village health workers per year) into one of three strata: (1) low altitude, proximal, large, (2) low altitude, mid-distance, medium, (3) high altitude, distal, small. One village is then randomly selected from each strata for each of the 5 clusters. All clusters start in the control condition and one cluster crosses over from control to intervention each month.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Antibiotic prescriptions at baseline visit
timeFrame: Baseline visit
Secondary outcomes:
measure: Clinical Failure (Composite Outcome)
timeFrame: Between baseline visit and Day 7 follow-up assessment
measure: Unexpected visits
timeFrame: Between baseline visit and Day 7 follow-up assessment
measure: Perceived improvement per caregiver
timeFrame: Day 7
measure: Persistent fever
timeFrame: Day 7
measure: Development of danger signs
timeFrame: Between Day 1 and Day 7
measure: Hospitalization
timeFrame: Between Day 1 and Day 7
measure: Death
timeFrame: Between Day 1 and Day 7
measure: Antibiotic prescriptions during study follow-up
timeFrame: Between baseline visit and Day 7 follow-up assessment
Other outcomes:
Locations:
city: Bugoye
country: Uganda
facility: Bugoye Health Center III
state: Kasese District
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Emily J Ciccone, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: