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

NCT07820332 | Not Yet Recruiting DMC

• 2 other identifiers: ComBac-AfricaClinicalTrialProject 101190791
• Study Type: interventional
• Target: 1,320
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bloodstream Infection Multidrug-resistant Gram-negative Bacteria

Keywords

multidrug-resistant gram-negative bacteria; ComBac-Africa

Outcome Measures

Primary Outcomes (1)

• Clinical cure

  All cause mortality after 14 days after treatment initiation Stage 1 versus Stage 2.

  14 days

Secondary Outcomes (8)

• Secondary outcomes

  28 days

• Secondary outcomes

  28 days

• Secondary outcomes

  28 days

• Secondary outcomes

  28 days

• Secondary outcomes

  28 days

Study Arms (1)

Treatment according to AMS algorithm

OTHER

There is no real separation into arms. Everyone will receive the applicable treatment. It is quasi-experimental.

Other: Treatment according to AMR algorithm

Interventions

Treatment according to AMR algorithm OTHER

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

Treatment according to AMS algorithm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität des Saarlandes: lead
• Swiss TPH, Basel, Switzerland: collaborator
• Institut Pasteur of Cote d'Ivoire: collaborator
• Centre Suisse de Recherches Scientifiques en Cote d'Ivoire: collaborator
• Global Antibiotics Research and Development Partnership: collaborator
• LINQ Management GMBH: collaborator
• Joseph Sarwuan Tarka University Makurdi: collaborator
• Instituto Piaget: collaborator
• Centre for Malaria and other Tropical Disease Care: collaborator
• Obafemi Awolowo University Teaching Hospital: collaborator

Related Links

• Related Info

Study Officials

• Aaron O Aboderin, Prof. Dr.

  Obafemi Awolowo University Nigeria

  STUDY CHAIR

Central Study Contacts

Sören L Becker, Prof. Dr. Dr.

CONTACT

+4968411623900; soeren.becker@uks.eu

Jacqueline Rehner, Dr.

CONTACT

+4915754996344; Jacqueline.Rehner@uks.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): November 1, 2027
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09