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Combating Multidrug-resistant Gram-negative Bacteria in Africa Through Diagnostic and Antimicrobial Stewardship

Study acronym: ComBac
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07820332
Lead Sponsor Universität des Saarlandes
Collaborators: Swiss TPH, Basel, Switzerland, Institut Pasteur of Cote d'Ivoire, Centre Suisse de Recherches Scientifiques en Cote d'Ivoire, Global Antibiotics Research and Development Partnership, LINQ Management GMBH, Joseph Sarwuan Tarka University Makurdi, Instituto Piaget, Centre for Malaria and other Tropical Disease Care, Obafemi Awolowo University Teaching Hospital
Conditions
(from sponsor)
Bloodstream Infection Multidrug-resistant Gram-negative Bacteria
Enrollment 1,320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov