An interventional study of Treatment according to AMR algorithm in Bloodstream Infection Multidrug-resistant Gram-negative Bacteria, sponsored by Universität des Saarlandes. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Universität des Saarlandes · Not applicable, Interventional, and Diagnostic
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 1,320 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
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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 by the patient or the patient's parent(s)/legal representative(s).
Exclusion Criteria:
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 to beta-lactam antibiotics
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There is no real separation into arms. Everyone will receive the applicable treatment. It is quasi-experimental.
Other: Treatment according to AMR algorithm
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
Clinical cure
All cause mortality after 14 days after treatment initiation Stage 1 versus Stage 2.
Time frame: 14 days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Universität des Saarlandes