Surveillance of AMR in DRC

NCT06821282 | Recruiting

• 1 other identifier: MID24001
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteremia

Keywords

Antimicrobial resistance (AMR); Surveillance; Malaria; Africa; Democratic Republic of Congo

Outcome Measures

Primary Outcomes (7)

• 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

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Oxford: lead
• University of Kinshasa: collaborator
• Mahidol University: collaborator
• Institut National de Recherche Biomédicale (INRB). Kinshasa, Democratic Republic of Congo: collaborator
• Department of Infectious Diseases, The Alfred Hospital and School of Translational Medicine, Monash University, Melbourne, Australia: collaborator

Study Sites (1)

Kinshasa, Democratic Republic of Congo, Kinshasa School of Public Health

Kinshasa, BP 11850, Democratic Republic of the Congo

RECRUITING

MeSH Terms

Conditions

Bacteremia; Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caterina Fanello, Dr.

CONTACT

+447900278768; caterina.fanello@ndm.ox.ac.uk

Marie Onyamboko, Prof

CONTACT

+243 859 204 166; marie.onyamboko@unikin.ac.cd

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: November 11, 2024
• Primary Completion: March 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of activities and reporting

Locations

DE (1)