Surveillance of AMR in DRC

NCT ID: NCT06821282

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-11

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study addresses knowledge gaps regarding antimicrobial resistance (AMR) in sub-Saharan Africa, focusing on evaluating the feasibility of AMR surveillance and enhancing local research capacity. Conducted at a general referral hospital in semirural Kinshasa, DRC, the study will investigate bacterial infections, their resistance profiles, and related risk factors, including co-infections such as malaria.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Antimicrobial resistance (AMR) is a significant global health threat, but its full impact in many African regions is still poorly understood. In collaboration with the Kinshasa School of Public Health, the Institut National de la Recherche Biomédicale (INRB) of DRC, and the University of Oxford, this study will assess the feasibility of implementing AMR surveillance in a general referral hospital in semirural Kinshasa, where onsite microbiological testing is currently unavailable. A key objective is to strengthen local research capacity by training staff in patient identification and specimen collection for AMR surveillance. The study will include patients over six months of age with suspected bloodstream infections at the time of hospital admission who agree to participate and from whom informed consent has been obtained. The focus is on community-acquired infections, excluding patients with significant prior healthcare or antibiotic exposure. Blood samples will be analyzed at INRB to determine the bacterial cause of infections, evaluate antimicrobial resistance levels, and identify associated risk factors, including co-infection with Plasmodium falciparum. Study results will be shared promptly with the hospital team to aid in patient management. Participants will be followed up for 28 days post-admission.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacteremia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients older than six months who present with a clinically suspected bloodstream infection upon admission to the hospital, or who have been hospitalized for less than 48 hours, and provide written consent (or consent from their caregiver/legal guardian) to participate will be included.

Exclusion Criteria

Patients with a significant history of healthcare exposure and those with any contraindications for phlebotomy as determined by the clinician's judgment, will be excluded.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Kinshasa

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role collaborator

Institut National de Recherche Biomédicale (INRB). Kinshasa, Democratic Republic of Congo

UNKNOWN

Sponsor Role collaborator

Department of Infectious Diseases, The Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caterina Fanello, Dr.

Role: PRINCIPAL_INVESTIGATOR

Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom (UK)

Sue J Lee, Dr.

Role: PRINCIPAL_INVESTIGATOR

Mahidol-Oxford Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok,Thailand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kinshasa, Democratic Republic of Congo, Kinshasa School of Public Health

Kinshasa, , Democratic Republic of the Congo

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Democratic Republic of the Congo

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Caterina Fanello, Dr.

Role: CONTACT

+447900278768

Marie Onyamboko, Prof

Role: CONTACT

+243 859 204 166

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marie Onyamboko, Prof

Role: primary

+243 859 204 166

Caterina Fanello, Dr.

Role: backup

+447900278768

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MID24001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.