Surveillance of Antimicrobial Resistance in Semirural Kinshasa, Democratic Republic of Congo: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Recruitment process
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Recruitment process
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Duration of recruitment, about six months
Antimicrobial resistance patterns of bacterial isolates.
Co-infection
时间窗: Duration of recruitment, about six months
Proportion of severe falciparum malaria patients diagnosed with concomitant BSI.
Outcome
时间窗: Study duration, plus 4 weeks
In-hospital and 28 day mortality
次要结局
未报告次要终点