Bloodstream Infection Multidrug-resistant Gram-negative BacteriaComBacNCT07820332
Combating Multidrug-resistant Gram-negative Bacteria in Africa Through Diagnostic and Antimicrobial Stewardship
A study testing Treatment according to AMR algorithm in people with Bloodstream Infection Multidrug-resistant Gram-negative Bacteria, run by Universität des Saarlandes.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bloodstream Infection Multidrug-resistant Gram-negative Bacteria
- What is being tested?
- Treatment according to AMR algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2027to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combating Multidrug-Resistant Gram-Negative Bacteria in Africa Through Diagnostic and Antimicrobial Stewardship: A Multicentre, Prospective Quasi-experimental Two-stage Study
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.
Read the detailed description
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.
- Being tested
- Treatment according to AMR algorithm
- Keywords
- multidrug-resistant gram-negative bacteria, ComBac-Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment according to AMR algorithmOther
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment according to AMS algorithm | Other | There is no real separation into arms. Everyone will receive the applicable treatment. It is quasi-experimental. Receives: Other: Treatment according to AMR algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
All cause mortality after 14 days after treatment initiation Stage 1 versus Stage 2.
Measured: 14 days
Secondary outcomes (8)
Secondary outcomes
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
Measured: 28 days
Secondary outcomes
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
Measured: 28 days
Secondary outcomes
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
Measured: 28 days
Secondary outcomes
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
Measured: 28 days
Secondary outcomes
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
Measured: 28 days
Secondary outcomes
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
Measured: 28 days
Secondary outcomes
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
Measured: 28 days
Secondary outcomes
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Nov 2027 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream Infection Multidrug-resistant Gram-negative BacteriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Aaron O Aboderin, Prof. Dr., Study chair, Obafemi Awolowo University Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820332
- Sponsor's protocol ID
- ComBac-AfricaClinicalTrial
- Other IDs
- Project 101190791
- Acronym
- ComBac
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combating Multidrug-Resistant Gram-Negative Bacteria in Africa Through Diagnostic and Antimicrobial Stewardship: A Multicentre, Prospective Quasi-experimental Two-stage Study
- ClinicalTrials.gov ID
- NCT07820332
- Acronym / sponsor ID
- ComBac / ComBac-AfricaClinicalTrial
- Keywords
- multidrug-resistant gram-negative bacteria, ComBac-Africa
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- 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
- Study start
- 1 Nov 2027 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment according to AMS algorithm | Other | Other: Treatment according to AMR algorithmThere is no real separation into arms. Everyone will receive the applicable treatment. It is quasi-experimental. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment according to AMR algorithmIn 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 | Other | Treatment according to AMS algorithm |
Primary outcome
Clinical cure
Time frame: 14 days
All cause mortality after 14 days after treatment initiation Stage 1 versus Stage 2.
8 secondary outcomes
Secondary outcomes
Time frame: 28 days
Secondary outcomes
Time frame: 28 days
Secondary outcomes
Time frame: 28 days
Secondary outcomes
Time frame: 28 days
Secondary outcomes
Time frame: 28 days
Secondary outcomes
Time frame: 28 days
Secondary outcomes
Time frame: 28 days
Secondary outcomes
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron O Aboderin, Prof. Dr. study chair
Obafemi Awolowo University Nigeria
Questions about this trial
What is this clinical trial studying?
A study testing Treatment according to AMR algorithm in people with Bloodstream Infection Multidrug-resistant Gram-negative Bacteria, run by Universität des Saarlandes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sören L Becker, Prof. Dr. Dr. (+4968411623900, soeren.becker@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.