NCT05378880: CABU-B/C

Optimising Community Antibiotic Use and Infection Control With Behavioural Interventions in Burkina Faso and DR Congo

Completed NA Last updated 3 October 2025

What this trial tests

NA trial testing Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission in Antimicrobial Stewardship in 5,532 participants. Completed in 12 December 2024.

Timeline

18 May 2022

Primary endpoint
3 April 2024

12 December 2024

Quick facts

Lead sponsor	Institute of Tropical Medicine, Belgium
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	5,532
Start date	18 May 2022
Primary completion	3 April 2024
Estimated completion	12 December 2024
Sites	2 locations across Democratic Republic of the Congo, Burkina Faso

Drugs / interventions tested

• Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission

Conditions studied

• Antimicrobial Stewardship — all drugs for Antimicrobial Stewardship →
• Drug Resistance, Bacterial — all drugs for Drug Resistance, Bacterial →

Sponsor

Institute of Tropical Medicine, Belgium

Who can join

Eligibility, any sex, with Antimicrobial Stewardship or Drug Resistance, Bacterial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Emergence of antibiotic resistance (AMR) is a serious concern for Low and Middle Income Countries (LMICs). Unregulated use of antibiotics, a major AMR driver, is highly prevalent in LMICs, with medicine stores as key providers. Physical interactions between One Health compartments increase cross-domain transmission risks, although the relative importance of different reservoirs is uncertain, with community-level dynamics of AMR in LMICs largely unquantified. In two rural health districts in Burkina Faso and DR Congo, a behavioural intervention bundle will be developed, targeting medicine stores and their communities, to optimise antibiotic use and improve hygiene, and hence reduce AMR prevalence and transmission. After a 6-month local co-development phase, the intervention will be implemented over 12 months and evaluated through a comparison between intervention and control clusters, consisting of one or more villages or neighbourhoods largely seeking healthcare with the same provider(s). The primary outcome measure is the change in Watch antibiotic provision from medicine stores (where a formal prescription is not required), assessed via patient exit interviews and simulated client visits. Changes in hygiene practices and AMR pathogen and gene carriage will be assessed in repeated population surveys. Rodents, living in close proximity to humans in much of sub-Sahara Africa, provide a proxy estimate of environmental AMR pathogen and gene exposure. Using modelling and sequencing of selected isolates, impact of AMR transmission by changes in antibiotic use and hygiene practices will be quantified.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluating the effect of a behavioural intervention bundle on antibiotic use, quality of care, and household transmission of resistant Enterobacteriaceae in intervention versus control clusters in rural Burkina Faso and DR Congo (CABU-EICO).
   CABU-EICO consortium. · · 2024 · cited 4× · PMID 38281023 · DOI 10.1186/s13063-023-07856-2
2. Evaluating the effect of a behavioural intervention bundle on antibiotic use, quality of care, and household transmission of resistant Enterobacteriaceae in intervention versus control clusters in rural Burkina Faso and DR Congo (CABU-EICO)
   CABU-EICO Consortium. · · 2023 · DOI 10.21203/rs.3.rs-3441433/v1