Surveillance of AMR in DRC (SARKIN)

Surveillance of Antimicrobial Resistance in Semirural Kinshasa, Democratic Republic of Congo: a Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Bacteremia

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 Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: Caterina Fanello, Dr.; Phone Number: +447900278768; Email: caterina.fanello@ndm.ox.ac.uk
• Study Contact Backup: Name: Marie Onyamboko, Prof; Phone Number: +243 859 204 166; Email: marie.onyamboko@unikin.ac.cd

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the, BP 11850
    • Recruiting
    • Kinshasa, Democratic Republic of Congo, Kinshasa School of Public Health
    • Contact: Caterina Fanello, Dr.; Phone Number: +447900278768; Email: caterina.fanello@ndm.ox.ac.uk
    • Contact: Marie Onyamboko, Prof; Phone Number: +243 859 204 166; Email: marie.onyamboko@unikin.ac.cd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients older than 6 months, admitted to the Hospital with a clinical suspicion of bloodstream infection.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment process	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.	Duration of recruitment, about six months
Intervention delivery	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.	Duration of recruitment, about six months
Processing time	The time from patient enrolment to blood sample collection and to transfer to the laboratory will be measured.	Duration of recruitment, about six months
Number of Bacterial Bloodstream Infections	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.	Duration of recruitment, about 6 months
Antimicrobial Susceptibility	Antimicrobial resistance patterns of bacterial isolates.	Duration of recruitment, about six months
Co-infection	Proportion of severe falciparum malaria patients diagnosed with concomitant BSI.	Duration of recruitment, about six months
Outcome	In-hospital and 28 day mortality	Study duration, plus 4 weeks

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Kinshasa School of Public Health, School of Medicine, University of Kinshasa, Democratic Republic of Congo; Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Institut National de Recherche Biomédicale (INRB). Kinshasa, Democratic Republic of Congo; Department of Infectious Diseases, The Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia
• Investigators: Principal Investigator: Caterina Fanello, Dr., Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom (UK); Principal Investigator: Sue J Lee, Dr., Mahidol-Oxford Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok,Thailand

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Malaria; Africa; Surveillance; Democratic Republic of Congo; Antimicrobial resistance (AMR)
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Bacteremia
• Other Study ID Numbers: MID24001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Key variables on pathogen identified and AMR will be shared through GRAM (URL: https://www.tropicalmedicine.ox.ac.uk/gram) All other data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.
• IPD Sharing Time Frame: After completion of activities and reporting

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No