PACTR202607729609431进行中（未招募）不适用
Combating Multidrug-Resistant Gram-Negative Bacteria in Africa through Diagnostic and Antimicrobial Stewardship: A multicentre, prospective quasi-experimental two-stage study
Saarland University0 个研究点目标入组 1,320 人开始时间: 2026年8月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 12 Month(s)（—）
- 性别
- All
入选标准
- •Patient with detection of a presumably MDR GNB (identified by growth on MDR screening agars or phenotypic resistance to ceftriaxone or meropenem) in =1 blood culture bottle
- •Provision of written informed consent to participate in the study by patient or her/his parents/legal (or legally acceptable) representative(s). In severely ill patients, an emergency consenting procedure will be implemented as an alternative for regular consenting. In addition to the legal guardian’s written consent, oral or written assent will be sought from children aged 6-11 years and 12-17 years, respectively. Age-appropriate assent forms will be used. For neonates and critically ill infants, enrolment will be subject to additional review by the site principal investigator to ensure minimal risk and clear clinical justification.
- •Capability of the patient or her/his parents/ legal representative(s) to understand the purpose and risks of the study, as judged by the recruiting physician
排除标准
- •Patients with negative blood culture or with detection of Gram-positive bacteria or mycobacteria or fungi in blood culture
- •Patients with GNB in blood culture that are not resistant to third-generation cephalosporins (ceftriaxone) or carbapenems (meropenem)
- •Patients with polymicrobial bloodstream infection (defined as isolation of =2 clinically significant microorganisms from blood cultures obtained within the same infectious episode; does not apply when additional organisms are considered likely contaminants rather than true pathogens (e.g. Staphylococcus epidermidis in a single bottle))
- •Patients with GNB detected in blood cultures and without systemic infection signs, in whom the microbiological finding is unambiguously interpreted as contamination not necessitating antimicrobial treatment
- •Patients already recruited for concurrent participation in other clinical studies or trials
- •Patients with known anaphylactic reactions or severe hypersensitivity to beta-lactam antibiotics
- •Participants in whom initial screening suggests MDR GNB (growth on MDR screening agars or phenotypic resistance to ceftriaxone or meropenem), but confirmatory testing reveals susceptible organisms (GNB in blood culture that are not resistant to ceftriaxone or meropenem), will be considered post-enrolment exclusions. In stage 2, these participants will be followed for a further 24 hours for safety reasons, but will be otherwise excluded from the study. As they will not contribute to the study population, they will be replaced by another participant. In stage 1, safety reporting in participants excluded post-enrolment will depend on the national requirements in the study countries
研究者
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