An observational study in Bacteremia, sponsored by University of Oxford. Recruiting at 1 site in Democratic Republic of the Congo. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Oxford · Observational
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.
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.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 210 is below the median of 300 across 125 observational studies indexed under Bacteremia.
Browse Bacteremia studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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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 for phlebotomy as determined by the clinician's judgment, will be excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of recruitment, about 6 months
Antimicrobial Susceptibility
Antimicrobial resistance patterns of bacterial isolates.
Time frame: Duration of recruitment, about six months
Co-infection
Proportion of severe falciparum malaria patients diagnosed with concomitant BSI.
Time frame: Duration of recruitment, about six months
Outcome
In-hospital and 28 day mortality
Time frame: Study duration, plus 4 weeks
Plan to share: 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.
Time frame: After completion of activities and reporting
Data sharing details ↗ · www.tropmedres.ac
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