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Recruiting NCT06821282

Surveillance of AMR in DRC

— Observational Bacteremia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Bacteremia. Basic parameters: from 6 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Democratic Republic of the Congo
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Recruitment process [Time frame: Duration of recruitment, about six months]
  • Intervention delivery [Time frame: Duration of recruitment, about six months]
  • Processing time [Time frame: Duration of recruitment, about six months]
  • Number of Bacterial Bloodstream Infections [Time frame: Duration of recruitment, about 6 months]
  • Antimicrobial Susceptibility [Time frame: Duration of recruitment, about six months]
  • Co-infection [Time frame: Duration of recruitment, about six months]
  • Outcome [Time frame: Study duration, plus 4 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Democratic Republic of the Congo · 1 center
  • Kinshasa, Democratic Republic of Congo, Kinshasa School of Public Health — Kinshasa

Identifiers

NCT: NCT06821282 · MID24001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗