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

NCT05378880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5532

Last updated 2025-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Antimicrobial Stewardship
  • Drug Resistance, Bacterial

Interventions

BEHAVIORAL

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

The study teams will work with communities and authorities to develop, implement and evaluate a multifaceted intervention bundle that will optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission, by targeting the general public (including farmers) and medicine stores.

Sponsors & Collaborators

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    collaborator OTHER_GOV
  • Centre de Recherche en Santé de Kimpese

    collaborator UNKNOWN
  • Universiteit Antwerpen

    collaborator OTHER
  • Institut Pasteur

    collaborator INDUSTRY
  • University of Oxford

    collaborator OTHER
  • University of Cambridge

    collaborator OTHER
  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Marianne AB van der Sande, PhD Pr · Institute of Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2024-04-03
Completion
2024-12-12

Countries

  • Burkina Faso
  • Democratic Republic of the Congo

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378880 on ClinicalTrials.gov