Surveillance of AMR in DRC

Recruiting

• Conditions: Bacteremia

• Registration Number: NCT06821282
• Lead Sponsor: University of Oxford

Brief Summary

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

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.

Study Timeline

• Study Start: 2024-11-11
• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-11
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-03-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment process	Duration of recruitment, about six months	The feasibility of establishing AMR surveillance at a referral hospital in Kinshasa, DRC will be assessed by evaluating the number of eligible patients, the number of patients who consent and the number of enrolled patients by syndrome each month with blood samples collected.
Intervention delivery	Duration of recruitment, about six months	Another key feasibility metric will be to assess the proportion of samples with final results from the microbiology lab, the proportion of possibly contaminated blood cultures, and the proportion of positive cultures with antimicrobial susceptibility testing.
Processing time	Duration of recruitment, about six months	The time from patient enrolment to blood sample collection and to transfer to the laboratory will be measured.
Number of Bacterial Bloodstream Infections	Duration of recruitment, about 6 months	The characterization of bacterial bloodstream infections (BSI) will be assessed by the frequency of positive blood cultures in patients with suspected BSI, the proportion of severe falciparum malaria patients diagnosed with concomitant BSI, and the outcome of BSI, in-hospital mortality, and 28-day mortality.
Antimicrobial Susceptibility	Duration of recruitment, about six months	Antimicrobial resistance patterns of bacterial isolates.
Co-infection	Duration of recruitment, about six months	Proportion of severe falciparum malaria patients diagnosed with concomitant BSI.
Outcome	Study duration, plus 4 weeks	In-hospital and 28 day mortality

Trial Locations

Locations (1)

Kinshasa, Democratic Republic of Congo, Kinshasa School of Public Health; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the