Bacteremia
Conditions
Keywords
Antimicrobial resistance (AMR), Surveillance, Malaria, Africa, Democratic Republic of Congo
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.
Interventions
None listed
Sponsors
University of Oxford
University of Kinshasa
Mahidol University
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Department of Infectious Diseases, The Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment process | 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. |
| Intervention delivery | 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. |
| Processing time | Duration of recruitment, about six months | The time from patient enrolment to blood sample collection and to transfer to the laboratory will be measured. |
| Number of Bacterial Bloodstream Infections | 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. |
| Antimicrobial Susceptibility | Duration of recruitment, about six months | Antimicrobial resistance patterns of bacterial isolates. |
| Co-infection | Duration of recruitment, about six months | Proportion of severe falciparum malaria patients diagnosed with concomitant BSI. |
| Outcome | Study duration, plus 4 weeks | In-hospital and 28 day mortality |
Countries
Democratic Republic of the Congo
Contacts
CONTACTCaterina Fanello, Dr.
CONTACTMarie Onyamboko, Prof
PRINCIPAL_INVESTIGATORCaterina Fanello, Dr.
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom (UK)
PRINCIPAL_INVESTIGATORSue J Lee, Dr.
Mahidol-Oxford Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok,Thailand
Outcome results
None listed