Combating Multidrug-resistant Gram-negative Bacteria in Africa Through Diagnostic and Antimicrobial Stewardship (ComBac)
Combating Multidrug-Resistant Gram-Negative Bacteria in Africa Through Diagnostic and Antimicrobial Stewardship: A Multicentre, Prospective Quasi-experimental Two-stage Study
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
A multicentric, prospective, quasi-experimental study, consisting of two stages, i.e. one observational stage and one interventional stage. The study will be conducted in a total of six hospitals in three countries: Côte d'Ivoire, Guinea-Bissau and Nigeria.
During the preparatory phase of this study and before the observational study stage 1 starts, blood culture diagnostics and indications for microbiological sampling will be harmonized across all sites and site feasibility assessments will be conducted.
Study stage 1: Antimicrobial susceptibility data of all GNB BSI and detailed assessment of the epidemiology, antimicrobial susceptibility and clinical outcome of MDR GNB in patients with BSIs and their clinical evolution following the standard of care at the individual sites will be collected. Duration: 12 months.
Algorithm development: Based on data obtained during stage 1, setting-tailored diagnosis-treatment algorithms that provide guidance on and access to novel antibiotics will be developed. Duration: ≤6 months
Study stage 2: Implementation of the clinical diagnosis-treatment algorithm in routine clinical care through AMS teams and evaluation of the effects of the algorithm implementation on mortality, the clinical outcome and microbiological cure. Duration: 12 months.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Sören L Becker, Prof. Dr. Dr.
- 전화번호: +4968411623900
- 이메일: soeren.becker@uks.eu
연구 연락처 백업
- 이름: Jacqueline Rehner, Dr.
- 전화번호: +4915754996344
- 이메일: Jacqueline.Rehner@uks.eu
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Patient with detection of a presumed multidrug-resistant Gram-negative bacterium (MDR GNB), identified by growth on MDR screening agar, in ≥1 blood culture bottle.
Provision of written informed consent by the patient or the patient's parent(s)/legal representative(s).
Exclusion Criteria:
- 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 cefotaxim) or carbapenems (meropenem)
Patients with polymicrobial infection
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
Patient already recruited for concurrent participation in other clinical studies or trials
Patients with known anaphylactic reactions or severe hypersensitivity to beta-lactam antibiotics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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다른: Treatment according to AMS algorithm
There is no real separation into arms.
Everyone will receive the applicable treatment.
It is quasi-experimental.
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In this study stage, a diagnosis-treatment algorithm that will have been developed based on data collected during study stage 1, will be employed as the intervention to guide the choice of antibiotics active against MDR GNB BSIs.
Coupled to the algorithm, a set of specific antibiotics will be made available in the different study settings for treatment of patients with infections due to MDR GNB, for which no equally effective antibiotics are routinely available in the study countries.
Previously held discussions with the regulatory agencies in the study countries will feed into the development of the algorithm.
The novel treatment options include antibiotics which retain activity in MDR GNB with specific resistance profiles such as ESBL-producing isolates and those with carbapenem resistance.
If an antibiotic is not yet licensed in the study country, its use will follow the European Medicines Agency's (EMA) licensing recommendations.
The following drugs will be used whenever the causa
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical cure
기간: 14 days
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All cause mortality after 14 days after treatment initiation Stage 1 versus Stage 2.
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14 days
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary outcomes
기간: 28 days
|
Stage 1 versus Stage 2 Clinical cure Description: Proportion of participants achieving clinical cure within 7 days of inclusion, defined as resolution or significant improvement of signs and symptoms of infection (e.g., fever, hemodynamic instability, organ dysfunction), based on the judgement of the treating physician and, where applicable, the antimicrobial stewardship (AMS) team using a standardized clinical assessment sheet in conjunction with laboratory parameters. Time Frame: Within 7 days after inclusion |
28 days
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Secondary outcomes
기간: 28 days
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Stage 1 versus Stage 2 for all mentioned below: All-cause mortality Description: Proportion of participants who die from any cause within 28 days after inclusion. Time Frame: Day 28 |
28 days
|
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Secondary outcomes
기간: 28 days
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Stage 1 versus Stage 2 Microbiological cure Description: Proportion of participants achieving clearance of bloodstream infection, defined as at least one negative pair of blood culture bottles drawn ≥48 hours after treatment initiation and no subsequent positive blood culture with the same pathogen identified. Time Frame: Up to Day 28 |
28 days
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Secondary outcomes
기간: 28 days
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Adherence to the clinical algorithm Description: Proportion of treatment decisions in Stage 2 that are consistent with the study clinical algorithm. Time Frame: During antimicrobial treatment, up to Day 28 |
28 days
|
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Secondary outcomes
기간: 28 days
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Appropriateness of antimicrobial therapy Description: Proportion of participants receiving antimicrobial therapy deemed appropriate according to pathogen susceptibility results and study treatment guidelines. Time Frame: Up to Day 28 |
28 days
|
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Secondary outcomes
기간: 28 days
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MDR pathogen-specific mortality Description: Proportion of participants with bloodstream infection caused by multidrug-resistant Gram-negative bacteria who die within 28 days. Time Frame: Day 28 |
28 days
|
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Secondary outcomes
기간: 28 days
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Adverse event profile of study antimicrobials Description: Incidence and severity of adverse events associated with meropenem, ceftazidime-avibactam, cefiderocol, and ceftazidime-avibactam plus aztreonam, as applicable. Time Frame: Up to Day 28 |
28 days
|
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Secondary outcomes
기간: 28 days
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Clonality of MDR Gram-negative bloodstream isolates Description: Genetic relatedness of multidrug-resistant Gram-negative bacterial strains isolated from bloodstream infections at participating hospitals, assessed by molecular typing methods. Time Frame: During study period and analysis of collected isolates |
28 days
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 의자: Aaron O Aboderin, Prof. Dr., Obafemi Awolowo University Nigeria
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- ComBac-AfricaClinicalTrial
- Project 101190791 (기타 식별자: EDCTP3)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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