Clinical trial NCT06821282: Surveillance of AMR in DRC
Official title: Surveillance of Antimicrobial Resistance in Semirural Kinshasa, Democratic Republic of Congo: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacteremia
Keywords: Antimicrobial resistance (AMR)
Surveillance
Malaria
Africa
Democratic Republic of Congo
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Kinshasa School of Public Health, School of Medicine, University of Kinshasa, Democratic Republic of Congo
name: Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
name: Institut National de Recherche Biomédicale (INRB). Kinshasa, Democratic Republic of Congo
name: Department of Infectious Diseases, The Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia
First posted: 2025-02-11
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 6 months, admitted to the Hospital with a clinical suspicion of bloodstream infection.

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.

Eligibility 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. 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.

Primary outcomes:
measure: Recruitment process
timeFrame: Duration of recruitment, about six months
measure: Intervention delivery
timeFrame: Duration of recruitment, about six months
measure: Processing time
timeFrame: Duration of recruitment, about six months
measure: Number of Bacterial Bloodstream Infections
timeFrame: Duration of recruitment, about 6 months
measure: Antimicrobial Susceptibility
timeFrame: Duration of recruitment, about six months
measure: Co-infection
timeFrame: Duration of recruitment, about six months
measure: Outcome
timeFrame: Study duration, plus 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa, Democratic Republic of Congo, Kinshasa School of Public Health
Study officials:
affiliation: Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom (UK)
name: Caterina Fanello, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol-Oxford Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok,Thailand
name: Sue J Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References: