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NCT Number: NCT06821282

Surveillance of AMR in DRC

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Malaria Mosquito-Borne Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protozoan Infections Sepsis Systemic Inflammatory Response Syndrome Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Recruitment process

    Time frame: 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.

  2. Intervention delivery

    Time frame: 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.

  3. Processing time

    Time frame: Duration of recruitment, about six months

    The time from patient enrolment to blood sample collection and to transfer to the laboratory will be measured.

  4. Number of Bacterial Bloodstream Infections

    Time frame: 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.

  5. Antimicrobial Susceptibility

    Time frame: Duration of recruitment, about six months

    Antimicrobial resistance patterns of bacterial isolates.

  6. Co-infection

    Time frame: Duration of recruitment, about six months

    Proportion of severe falciparum malaria patients diagnosed with concomitant BSI.

  7. Outcome

    Time frame: Study duration, plus 4 weeks

    In-hospital and 28 day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Caterina Fanello, Dr.

CONTACT

[email protected]

+447900278768

Marie Onyamboko, Prof

CONTACT

[email protected]

+243 859 204 166

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Department of Infectious Diseases, The Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia
  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
  • Mahidol University
  • University of Kinshasa

Registry information

Official study title

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

Acronym: SARKIN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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