Antimicrobial StewardshipCABU-B/CNCT05378880
Optimising Community Antibiotic Use and Infection Control With Behavioural Interventions in Burkina Faso and DR Congo
A study testing Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission in people with Antimicrobial Stewardship and Drug Resistance, Bacterial, run by Institute of Tropical Medicine, Belgium at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Stewardship, Drug Resistance, Bacterial
- What is being tested?
- Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,532 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 May 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Visitor to a medicine dispenser for his/her own health or that of someone else, regardless of disease or age
- Having just completed a visit to a medicine dispenser in a study cluster who agreed to participate in the study Exclusion Criteria: none
- Simulated patient visits (dispensers)
- Prescribe or dispense medicines in a community pharmacy, medicine store, or other private clinic or outlet within the selected study clusters;
- Consented at the start of the study to participate in the intervention bundle evaluation Exclusion Criteria: none
- Faecal Enterobacteriaceae carriage and transmission (members of selected households) and household surveys (household heads) Inclusion criteria
Show all 12Show fewer
- Member of a household in a study cluster (resident for >/= 3 months);
- Agreement of the household head for all household members (including children) to participate to the collection of four stool samples during the study period, through informed written consent;
- Individual informed consent (plus assent for adolescent participants) for each participating household member;
- be in good physical health (no current infectious disease); Exclusion criteria
- Inhabitant of study clusters who planned to move or be absent during the following year;
- Temporary exclusion: Ongoing infectious disease or ongoing treatment for an infectious disease. Field workers will return to collect stools once the patient has recovered
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Democratic Republic of the Congo1 site
Centre de Recherche en Santé de Kimpese (CRSK)
Kimpese
About this study
Official title: Optimisation de l'Usage d'Antibiotiques et contrôle Des Infections au Niveau Communautaire Par un Paquet d'Interventions Ciblant le Comportement au Burkina Faso et en République Démocratique du Congo
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.
Read the detailed description
Background A major driver of AMR emergence in LMICs is community- and individual-level antibiotic consumption, which have both been associated with an increased risk of acquisition of AMR bacteria for individuals in the general community. As a result of difficult or delayed access to hospitals and formal health centres, the principal sources of antibiotics in many LMIC communities are medicine stores, i.e. community pharmacies or informal medicine vendors. Staff at these outlets are frequently not medically qualified, and informal selling of medicines is common. Two recent systematic reviews estimated the pooled prevalence of reported self-medication with antibiotics in LMICs at 78%, in sSA at 56%, and in West-Africa at 70%. Furthermore, in sSA, over two thirds of visits to community medicine stores were found to result in dispensing prescription-free antibiotics. Appropriately trained and motivated pharmacy staff can be part of a successful AMR control programme, in particular through their role in educating patients, promoting appropriate usage of dispensed antibiotics, and providing guidance to healthcare colleagues on appropriate antibiotic prescribing. In the absence of a clinical or microbiological diagnosis, medicine stores often dispense antibiotics without a clear rationale. Importantly, these antibiotic courses frequently consist of Watch antibiotics. Among the different types of providers listed, and even among those with a good understanding of AMR, there is a need for supporting appropriate antibiotic prescription practices.
A recent study in 6 LMICs showed that context-specific tailored intervention packages are key to improve community antibiotic use. In any stewardship programme targeting unregulated community dispensing of antibiotics, it is therefore crucial to co-develop interventions with medicine stores, and to incorporate the identification of alternative (economic) incentives, as well as targeting communities, to enable sustainable take-up by both medicine stores and their communities. Existing behavioural change interventions have been categorised as persuasive (eg. peer-to-peer feedback on dispensing), enabling (eg. guidelines, training sessions), restrictive (eg. expert approval before dispensing some specific antibiotics) or structural (eg. introducing a clinical algorithm). The effect of individual interventions targeting outpatient dispensing of antibiotics in LMIC has been heterogeneous, with multi-faceted interventions combining educational material with audits and feedback or peer-to-peer comparisons more effective at reducing inappropriate antibiotic use than stand-alone interventions.This project proposes a robust participatory-driven behaviour change intervention to reduce the use of Watch antibiotics from medicine stores, targeting both the demand (community) and supply (medicine store) side, and to reduce emergence and transmission of AMR.
To develop locally acceptable, feasible and relevant interventions, the COM-B model for behaviour change has been found highly suitable. This model forms the centre of the well-known Behaviour Change Wheel which is widely used in designing interventions and has been used by NICE and the UK Department of Health. COM-B identifies three essential conditions for behaviour - capability, opportunity, motivation - which thereby provide intervention opportunities for behaviour change. Capabilities include psychological (e.g. knowledge) and physical (e.g. skills) capabilities. Opportunity includes social and physical opportunities (e.g. social influences and environmental context and resources). Motivation includes reflective and automatic motivation such as beliefs about capabilities and consequences, goals, and ideas about professional role and identity. The intervention bundle in this study therefore aims to address AMR using three intervention components which each address the three conditions of behaviour change of the COM-B model. Target behaviours for the intervention are based upon considerations around impact potential, likelihood for change, potential spill-over effects as well as ease of measurement. The COM-B model would thus be highly suitable to guide ABU interventions addressing highly complex behaviour, and will be used to design the intervention bundles to achieve a joint change in antibiotic demand and supply.
At the same time, ongoing transmission of newly emerging or existing (drug-resistant) bacteria and the exchange of AMR genes between bacteria harboured by human hosts, animals and their environment, is facilitated by substandard hygiene and sanitation practices. Household transmission was recently found to be a more important mode of bacterial strain sharing than transmission from livestock in urban Nairobi.
The widespread environmental rummaging behaviour of rodents implies that they can serve as a proxy for AMR prevalence in the natural environment . This is of major relevance in settings where sewage surveillance, an alternative measurement to estimate environmental prevalence, may not (yet) be feasible because of the absence of sufficient sewage systems.
Study objectives
Primary
- Develop, implement, and evaluate the effect of a behavioural intervention bundle targeting medicine stores (including community pharmacies and informal medicine sellers), and the surrounding populations on (Watch) antibiotic use.
- Develop and pilot environmental AMR surveillance through rodent surveillance.
- Estimate and model the effect of the intervention bundle on AMR prevalence and transmission, focusing on faecal E. coli and Salmonella carriage.
Secondary
- Estimate the intervention bundle's effect on hygiene, on case management by medicine stores and on clinical outcomes.
- Identify pathways and incentives through which educational or peer influence interventions improve quality of care.
- Compare prevalence of AMR bacterial populations in human (i.e. household members) and rodent reservoirs; compare with AMR prevalence in routine BSI surveillance.
- Spatial and ecological analysis as well as phylogenetic comparison of AMR bacterial populations and genetic clones identified in human carriers and dwelling rodents.
- Quantify household transmission of AMR genes or pathogens and estimate the relative importance of an environmental transmission source.
- Being tested
- Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission
- Keywords
- behavioural intervention, sub-Sahara Africa, rodent surveillance, health demographic surveillance sites, Anti-Bacterial Agents / therapeutic use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmissionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention clusters | Experimental | Intervention bundle consisting of 3 components introduced over 12 months: one to improve antibiotic use targeting health centres and medicine stores and two targeting the general population: one to increase community health literacy and one to improve water, hygiene and sanitation practices. Receives: Behavioral: Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission |
| Control clusters | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the provision of Watch antibiotics
The change pre- to post-intervention in prevalence of dispensing Watch antibiotics at medicine stores or health centers estimated through repeated patient visit exit surveys
Measured: 12 months (change between baseline before the intervention and 12 months later)
Change in quality of care
The change pre- to post-intervention in a score of case management at medicine stores or health centers, derived from a predefined checklist filled in during simulated patient visits for 5 clinical presentations. For clinical presentation-specific selected anamnesis questions, examinations, checked symptoms, advice or medicine prescribed/dispensed, a point is added (if appropriate) or deducted (if inappropriate). Checklists are predefined following the 2021 WHO Antibiotic Book and local guidelines, and are provided in the protocol
Measured: 12 months (change between baseline before the intervention and 12 months later)
Secondary outcomes (3)
Change in rate of person-to-person transmission and duration of carriage of ESBL-producing E.coli within households
The change pre- to post-intervention in within-household transmission rate and loss of carriage estimated by fitting dynamic transmission models to repeatedly collected stool samples, cultured on EBSL selective media, and whole genome sequenced to determine genetic difference between ESBL-positive isolates from respective household members.
Measured: 12 months (stool sample collection at 0, 3, 6 and 12 months)
Change in hygiene practices and exposures
The change pre- to post-intervention in prevalence of uptake of hygiene practices and potential transmission risk exposures (contact with animals, uncooked food, meat consumption) at household level, measured by repeated household surveys.
Measured: 12 months
Change in dispensing of underdosed antibiotic courses
The change pre- to post-intervention in prevalence of dispensing underdosed antibiotic courses at medicine stores or health centers estimated through repeated patient visit exit surveys
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start18 May 2022
- Primary completion3 Apr 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial StewardshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 5,532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, Centre de Recherche en Santé de Kimpese, Universiteit Antwerpen, Institut Pasteur, University of Oxford, University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Marianne AB van der Sande, PhD Pr, Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378880
- Sponsor's protocol ID
- 1559/22
- Other IDs
- JPMIR2021-053
- Acronym
- CABU-B/C
- Status last verified
- Sep 2025
- First submitted
- 13 May 2022
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to study data (e.g., pathogen sequencing data, outcome data as antibiotic use or quality scores) will be in accordance with FAIR principles. Non-confidential data will be fully accessible (such as fully anonymized and aggregated data, pathogen sequencing data, intervention materials, recommendations, etc.). Confidential data (such as pseudonymized participant data, therefore individual but without identifiers) can be made accessible through controlled access procedures (ITM Research data access committee via ITMresearchdataaccess@itg.be). A data sharing agreement will always be in place prior to the transfer of confidential data.
Publications
CABU-EICO consortium. 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). Trials. 2024 Jan 27;25(1):91. doi: 10.1186/s13063-023-07856-2.
PubMed 38281023Aizouk R, Sibidou Y, Valia D, Ingelbeen B, Campbell L, Kouanda JS, Welgo A, Diagne PM, Riems B, Hardy L, Wouters E, Meudec M, van der Sande MAB, Halidou T, Cooper BS, van Kleef E; CABU-EICO study team. Effects of a community-based intervention bundle on household transmission of extended spectrum beta-lactamase-producing Escherichia coli in rural Burkina Faso to target community-level drivers of antimicrobial resistance in sub-Saharan Africa: a cluster-randomised trial. Lancet Microbe. 2026 Aug 6:101427. doi: 10.1016/j.lanmic.2026.101427. Online ahead of print.
PubMed 42561993Ingelbeen B, Valia D, Mbangi B, van Kleef E, Campbell L, Kouanda JS, Muaka CMK, Tiendrebeogo EW, Welgo A, Bertels V, Declercq S, Riems B, Meudec M, Wouters E, Cooper BS, Phanzu DM, Tinto H, van der Sande MAB; CABU-EICO Study Group. Effect of a community-based behavioural intervention bundle to improve antibiotic use and patient management in Burkina Faso and DR Congo (CABU-EICO): a cluster-randomised controlled trial. Lancet Infect Dis. 2026 Jun 15:S1473-3099(26)00169-6. doi: 10.1016/S1473-3099(26)00169-6. Online ahead of print.
PubMed 42296975
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation de l'Usage d'Antibiotiques et contrôle Des Infections au Niveau Communautaire Par un Paquet d'Interventions Ciblant le Comportement au Burkina Faso et en République Démocratique du Congo
- ClinicalTrials.gov ID
- NCT05378880
- Acronym / sponsor ID
- CABU-B/C / 1559/22
- Keywords
- behavioural intervention, sub-Sahara Africa, rodent surveillance, health demographic surveillance sites, Anti-Bacterial Agents / therapeutic use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,532 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, Centre de Recherche en Santé de Kimpese, Universiteit Antwerpen, Institut Pasteur, University of Oxford, University of Cambridge
- Study start
- 18 May 2022 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background A major driver of AMR emergence in LMICs is community- and individual-level antibiotic consumption, which have both been associated with an increased risk of acquisition of AMR bacteria for individuals in the general community. As a result of difficult or delayed access to hospitals and formal health centres, the principal sources of antibiotics in many LMIC communities are medicine stores, i.e. community pharmacies or informal medicine vendors. Staff at these outlets are frequently not medically qualified, and informal selling of medicines is common. Two recent systematic reviews estimated the pooled prevalence of reported self-medication with antibiotics in LMICs at 78%, in sSA at 56%, and in West-Africa at 70%. Furthermore, in sSA, over two thirds of visits to community medicine stores were found to result in dispensing prescription-free antibiotics. Appropriately trained and motivated pharmacy staff can be part of a successful AMR control programme, in particular through their role in educating patients, promoting appropriate usage of dispensed antibiotics, and providing guidance to healthcare colleagues on appropriate antibiotic prescribing. In the absence of a clinical or microbiological diagnosis, medicine stores often dispense antibiotics without a clear rationale. Importantly, these antibiotic courses frequently consist of Watch antibiotics. Among the different types of providers listed, and even among those with a good understanding of AMR, there is a need for supporting appropriate antibiotic prescription practices.
A recent study in 6 LMICs showed that context-specific tailored intervention packages are key to improve community antibiotic use. In any stewardship programme targeting unregulated community dispensing of antibiotics, it is therefore crucial to co-develop interventions with medicine stores, and to incorporate the identification of alternative (economic) incentives, as well as targeting communities, to enable sustainable take-up by both medicine stores and their communities. Existing behavioural change interventions have been categorised as persuasive (eg. peer-to-peer feedback on dispensing), enabling (eg. guidelines, training sessions), restrictive (eg. expert approval before dispensing some specific antibiotics) or structural (eg. introducing a clinical algorithm). The effect of individual interventions targeting outpatient dispensing of antibiotics in LMIC has been heterogeneous, with multi-faceted interventions combining educational material with audits and feedback or peer-to-peer comparisons more effective at reducing inappropriate antibiotic use than stand-alone interventions.This project proposes a robust participatory-driven behaviour change intervention to reduce the use of Watch antibiotics from medicine stores, targeting both the demand (community) and supply (medicine store) side, and to reduce emergence and transmission of AMR.
To develop locally acceptable, feasible and relevant interventions, the COM-B model for behaviour change has been found highly suitable. This model forms the centre of the well-known Behaviour Change Wheel which is widely used in designing interventions and has been used by NICE and the UK Department of Health. COM-B identifies three essential conditions for behaviour - capability, opportunity, motivation - which thereby provide intervention opportunities for behaviour change. Capabilities include psychological (e.g. knowledge) and physical (e.g. skills) capabilities. Opportunity includes social and physical opportunities (e.g. social influences and environmental context and resources). Motivation includes reflective and automatic motivation such as beliefs about capabilities and consequences, goals, and ideas about professional role and identity. The intervention bundle in this study therefore aims to address AMR using three intervention components which each address the three conditions of behaviour change of the COM-B model. Target behaviours for the intervention are based upon considerations around impact potential, likelihood for change, potential spill-over effects as well as ease of measurement. The COM-B model would thus be highly suitable to guide ABU interventions addressing highly complex behaviour, and will be used to design the intervention bundles to achieve a joint change in antibiotic demand and supply.
At the same time, ongoing transmission of newly emerging or existing (drug-resistant) bacteria and the exchange of AMR genes between bacteria harboured by human hosts, animals and their environment, is facilitated by substandard hygiene and sanitation practices. Household transmission was recently found to be a more important mode of bacterial strain sharing than transmission from livestock in urban Nairobi.
The widespread environmental rummaging behaviour of rodents implies that they can serve as a proxy for AMR prevalence in the natural environment . This is of major relevance in settings where sewage surveillance, an alternative measurement to estimate environmental prevalence, may not (yet) be feasible because of the absence of sufficient sewage systems.
Study objectives
Primary
- Develop, implement, and evaluate the effect of a behavioural intervention bundle targeting medicine stores (including community pharmacies and informal medicine sellers), and the surrounding populations on (Watch) antibiotic use.
- Develop and pilot environmental AMR surveillance through rodent surveillance.
- Estimate and model the effect of the intervention bundle on AMR prevalence and transmission, focusing on faecal E. coli and Salmonella carriage.
Secondary
- Estimate the intervention bundle's effect on hygiene, on case management by medicine stores and on clinical outcomes.
- Identify pathways and incentives through which educational or peer influence interventions improve quality of care.
- Compare prevalence of AMR bacterial populations in human (i.e. household members) and rodent reservoirs; compare with AMR prevalence in routine BSI surveillance.
- Spatial and ecological analysis as well as phylogenetic comparison of AMR bacterial populations and genetic clones identified in human carriers and dwelling rodents.
- Quantify household transmission of AMR genes or pathogens and estimate the relative importance of an environmental transmission source.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention clusters | Experimental | Behavioral: Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmissionIntervention bundle consisting of 3 components introduced over 12 months: one to improve antibiotic use targeting health centres and medicine stores and two targeting the general population: one to increase community health literacy and one to improve water, hygiene and sanitation practices. |
| Control clusters | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Visitor to a medicine dispenser for his/her own health or that of someone else, regardless of disease or age
- Having just completed a visit to a medicine dispenser in a study cluster who agreed to participate in the study Exclusion Criteria: none
- Simulated patient visits (dispensers)
- Prescribe or dispense medicines in a community pharmacy, medicine store, or other private clinic or outlet within the selected study clusters;
- Consented at the start of the study to participate in the intervention bundle evaluation Exclusion Criteria: none
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmissionThe 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. | Behavioural | Intervention clusters |
Primary outcome
Change in the provision of Watch antibiotics
Time frame: 12 months (change between baseline before the intervention and 12 months later)
The change pre- to post-intervention in prevalence of dispensing Watch antibiotics at medicine stores or health centers estimated through repeated patient visit exit surveys
Change in quality of care
Time frame: 12 months (change between baseline before the intervention and 12 months later)
The change pre- to post-intervention in a score of case management at medicine stores or health centers, derived from a predefined checklist filled in during simulated patient visits for 5 clinical presentations. For clinical presentation-specific selected anamnesis questions, examinations, checked symptoms, advice or medicine prescribed/dispensed, a point is added (if appropriate) or deducted (if inappropriate). Checklists are predefined following the 2021 WHO Antibiotic Book and local guidelines, and are provided in the protocol
3 secondary outcomes
Change in rate of person-to-person transmission and duration of carriage of ESBL-producing E.coli within households
Time frame: 12 months (stool sample collection at 0, 3, 6 and 12 months)
Change in hygiene practices and exposures
Time frame: 12 months
Change in dispensing of underdosed antibiotic courses
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Results publication: PubMed 38281023CABU-EICO consortium. 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). Trials. 2024 Jan 27;25(1):91. doi: 10.1186/s13063-023-07856-2.
- Derived from this study: PubMed 42561993Aizouk R, Sibidou Y, Valia D, Ingelbeen B, Campbell L, Kouanda JS, Welgo A, Diagne PM, Riems B, Hardy L, Wouters E, Meudec M, van der Sande MAB, Halidou T, Cooper BS, van Kleef E; CABU-EICO study team. Effects of a community-based intervention bundle on household transmission of extended spectrum beta-lactamase-producing Escherichia coli in rural Burkina Faso to target community-level drivers of antimicrobial resistance in sub-Saharan Africa: a cluster-randomised trial. Lancet Microbe. 2026 Aug 6:101427. doi: 10.1016/j.lanmic.2026.101427. Online ahead of print.
- Derived from this study: PubMed 42296975Ingelbeen B, Valia D, Mbangi B, van Kleef E, Campbell L, Kouanda JS, Muaka CMK, Tiendrebeogo EW, Welgo A, Bertels V, Declercq S, Riems B, Meudec M, Wouters E, Cooper BS, Phanzu DM, Tinto H, van der Sande MAB; CABU-EICO Study Group. Effect of a community-based behavioural intervention bundle to improve antibiotic use and patient management in Burkina Faso and DR Congo (CABU-EICO): a cluster-randomised controlled trial. Lancet Infect Dis. 2026 Jun 15:S1473-3099(26)00169-6. doi: 10.1016/S1473-3099(26)00169-6. Online ahead of print.
- Individual participant dataSharing planned: Yes. Access to study data (e.g., pathogen sequencing data, outcome data as antibiotic use or quality scores) will be in accordance with FAIR principles. Non-confidential data will be fully accessible (such as fully anonymized and aggregated data, pathogen sequencing data, intervention materials, recommendations, etc.). Confidential data (such as pseudonymized participant data, therefore individual but without identifiers) can be made accessible through controlled access procedures (ITM Research data access committee via ITMresearchdataaccess@itg.be). A data sharing agreement will always be in place prior to the transfer of confidential data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne AB van der Sande, PhD Pr principal investigator
Institute of Tropical Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural intervention bundle to optimise antibiotic use and reduce the risk of human-to-human or environmental-animal-human transmission in people with Antimicrobial Stewardship and Drug Resistance, Bacterial, run by Institute of Tropical Medicine, Belgium at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burkina Faso, Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the provision of Watch antibiotics (time frame: 12 months (change between baseline before the intervention and 12 months later)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378880, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.