BacteremiaSARKINNCT06821282
Surveillance of AMR in DRC
An observational study of Bacteremia, run by University of Oxford at 1 site in Democratic Republic of the Congo.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Bacteremia
- How many people
- 210 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 11 Nov 2024to 30 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients older than 6 months, admitted to the Hospital with a clinical suspicion of bloodstream infection.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Kinshasa, Democratic Republic of Congo, Kinshasa School of Public Health
Kinshasa, Kinshasa City, BP 11850
Marie Onyamboko, Prof, +243 859 204 166, marie.onyamboko@unikin.ac.cd
Caterina Fanello, Dr., +447900278768, caterina.fanello@ndm.ox.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Bacteremia
- Keywords
- Antimicrobial resistance (AMR), Surveillance, Malaria, Africa, Democratic Republic of Congo
- Medical subject headings
- Bacteremia, Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: Duration of recruitment, about 6 months
Antimicrobial Susceptibility
Antimicrobial resistance patterns of bacterial isolates.
Measured: Duration of recruitment, about six months
Co-infection
Proportion of severe falciparum malaria patients diagnosed with concomitant BSI.
Measured: Duration of recruitment, about six months
Outcome
In-hospital and 28 day mortality
Measured: Study duration, plus 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start11 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kinshasa, Mahidol University, Institut National de Recherche Biomedicale (INRB), Department of Infectious Diseases, The Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia
- Responsible party
- Sponsor
- Investigators
- Caterina Fanello, Dr., Principal investigator, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom (UK)Sue J Lee, Dr., Principal investigator, Mahidol-Oxford Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821282
- Sponsor's protocol ID
- MID24001
- Acronym
- SARKIN
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.