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NCT07820332
Combating Multidrug-resistant Gram-negative Bacteria in Africa Through Diagnostic and Antimicrobial Stewardship
Conditions: Bloodstream Infection Multidrug-resistant Gram-negative Bacteria
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 1320
Sponsor: Universität des Saarlandes
Summary
Antimicrobial resistance (AMR) is a major threat to public health and the well-being of humans, with high mortality rates of infections caused by MDR GNB. Sub-Saharan Africa (SSA) suffers from a high burden of AMR, but access to adequate microbiological diagnostics for pathogen identification and resistance testing as well as to novel antibiotics that are effective against MDR GNB are scarce. Studies from high-income countries show improved survival of patients with such infections, if novel antibiotics against these pathogens are employed in a targeted manner. However, data from low- and middle-income countries (LMICs) is limited. The purpose of this study is to obtain an accurate picture of the epidemiology of MDR GNB in hospitals in Côte d'Ivoire, Guinea-Bissau and Nigeria, followed by the development and implementation of an evidence-based AMS algorithm, which is coupled to access to antibiotics (i.e. meropenem, ceftazidime-avibactam, cefiderocol and ceftazidime-avibactam + aztreonam) with proven activity against MDR GNB. Taken together, the overall goal is to improve the management of severe infections due to MDR GNB in SSA.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07820332). StuddyBuddy aggregates publicly available trial information.