Clinical trials: Carbapenem-resistant Enterobacterales
Carbapenem-Resistant Enterobacteriaceae Infection
Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies
The first aim of this study is to explore the drug resistance mechanism of Enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (CAZ-AVI) in combination with aztreonam (ATM) against…
- Trial name
- NCT05850871
- Testing
- CAZ/AVI plus Aztreonam, Conventional treatment
- Where
- China
- Volunteers
- 427 people
- Sponsor
- Qianfoshan Hospital
Gram Negative Infections, Antimicrobial Resistance (AMR)
PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime/avibactam (CAZ/AVI) alone or with CAZ/AVI plus fosfomycin (FOS) for infection due to…
- Trial name
- CAVIFOS (NCT06717594)
- Where
- 2 sites in Italy, Spain
- Volunteers
- 60 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Infection With AmpC Beta-lactamase Producing Enterobacterales
Clinical Comparison of Treatment Strategies in AmpC Beta-lactamase Producing Enterobacterales in a Swiss Tertiary Care Hospital
This study is to investigate the recent epidemiological trends and the treatment outcome in terms of the length of hospital stay, the relevant renal and neurological side effects, risk factors for developing these side effects…
- Trial name
- AmpCstratBasel (NCT04577989)
- Testing
- data collection
- Where
- Switzerland
- Volunteers
- 270 people
- Sponsor
- University Hospital, Basel, Switzerland
Enterobacteriaceae Infections, Community-Acquired Infections
Community-associated Highly-Resistant Enterobacterales
This is a prospective multi-center study. Bacterial isolates from hospitalized patients with CA-HRE will be compared to those from hospitalized patients with healthcare-associated HRE (HA-HRE).
- Conditions
- Enterobacteriaceae Infections, Community-Acquired Infections, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection
- Trial name
- COCARE (NCT03924934)
- Where
- United States
- Volunteers
- 2,172 people
- Sponsor
- University of North Carolina, Chapel Hill
Colonization, Asymptomatic
Decolonization of Carbapenem-resistant Enterobacterales (CRE) in Patients With Faecal Carriage of CRE With Neomycin
Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes.
- Trial name
- NCT05593601
- Testing
- Neomycin
- Where
- Thailand
- Volunteers
- 60 people
- Sponsor
- Mahidol University
Blood Stream Infections, Ventilator Associated Pneumonia
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
RAPID is an investigator initiated Phase 4, multinational, multicentre, open-label, randomised controlled superiority trial evaluating the clinical impact of rapid microbiological diagnostics combined with antimicrobial…
- Conditions
- Blood Stream Infections, Ventilator Associated Pneumonia, Healthcare Associated Infection, Carbapenem-Resistant Enterobacteriaceae Infection
- Trial name
- RAPID (NCT05979545)
- Testing
- Rapid Diagnostics
- Where
- 21 sites in India, Malaysia and 5 more
- Volunteers
- 1,526 people
- Sponsor
- National University of Singapore
Multi-antibiotic Resistance
Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient
The goal of this observational study is to evaluate the screening for multidrug resistant bacteria in patients admitted to hospitals in Scania.
- Trial name
- NCT06370299
- Testing
- (exposure of) MDR carriage
- Volunteers
- 10,000 people
- Sponsor
- Region Skane
Healthcare-Associated Infections (HAIs), Carbapenem-Resistant Enterobacteriaceae Colonization
Correlation Between Carbapenemase-Producing Enterobacterales Load, Environmental Contamination, and Transmission in Critical Care Units
Carbapenemase-producing Enterobacterales (CPE) are multidrug-resistant bacteria that can colonize the gastrointestinal tract of hospitalized patients and spread within intensive care units (ICUs).
- Conditions
- Healthcare-Associated Infections (HAIs), Carbapenem-Resistant Enterobacteriaceae Colonization, Antimicrobial Resistance (AMR)
- Trial name
- CPE-Load ICU S (NCT07685132)
- Where
- Argentina
- Volunteers
- 60 people
- Sponsor
- Hospital Italiano de Buenos Aires
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Carbapenem-resistant Enterobacterales
Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Patients
The goal of this observational study is to characterize the clinical features of metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) colonization and subsequent infection in patients after allogeneic…
- Trial name
- NCT07324291
- Volunteers
- 1,000 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Complicated Intra-Abdominal Infections, cIAIs, Hospital-acquired Pneumonia (HAP)
Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE
Why This Study is Needed Some bacterial infections have become resistant to common antibiotics, making them very difficult to treat. This is a growing and serious health problem.
- Conditions
- Complicated Intra-Abdominal Infections, cIAIs, Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
- Trial name
- AWARE (NCT07268560)
- Testing
- Aztreonam-Avibactam
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Sir Run Run Shaw Hospital
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
Aztreonam-Avibactam in Immunocompromised Hosts
The goal of this observational study is to learn about the effectiveness and safety of aztreonam-avibactam, an antibiotic used to treat infections caused by highly resistant bacteria, in adults with weakened immune systems.
- Conditions
- Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection, Immunocompromised Host, Drug Resistance, Multiple, Bacterial
- Trial name
- IMMUNO-AVI (NCT07890480)
- Testing
- Aztreonam-Avibactam, Ceftazidime-Avibactam Plus Aztreonam
- Where
- Argentina
- Volunteers
- 814 people
- Sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Gram Negative Infection, Antimicrobial Resistance (AMR)
PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections
A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination…
- Trial name
- PACCOF (NCT06651047)
- Where
- 11 sites in Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Bologna
Bloodstream Infections, Enterobacteriaceae Infections
ANTIBIOTIC-RESISTANT ENTEROBACTERALES BLOODSTREAM INFECTIONS AND RISK FACTORS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT
In this study, we first aimed to reveal the resistance profile of Enterobacteriales bloodstream infections at our center. We evaluated data from patients with ESBL, colistin, and carbapenem resistance and identified resistance…
- Conditions
- Bloodstream Infections, Enterobacteriaceae Infections, Intensive Care (ICU), Antibiotic Resistant Infection
- Trial name
- NCT07172932
- Where
- Turkey (Türkiye)
- Volunteers
- 314 people
- Sponsor
- Ankara City Hospital Bilkent
Complicated Urinary Tract Infection, Acute Pyelonephritis
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
This study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the…
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis, Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- Integral-2 (NCT05905055)
- Testing
- co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, BAT
- Where
- 54 sites in China, Croatia and 12 more
- Volunteers
- 126 people
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Carbapenem-resistant Enterobacterales, Neutropenia
Prospective Study Evaluate the Timing of Empirical Treatment for Carbapenem-resistant Bacterials (CROEAT Study)
In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO.
- Conditions
- Carbapenem-resistant Enterobacterales, Neutropenia, Hematological Malignancies
- Trial name
- NCT07047352
- Testing
- Empirical treatment
- Where
- China
- Volunteers
- 91 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Enterobacteriaceae Infections, Carrier State
Study of Probiotic Adjunctive Therapy for Decolonization of Carbapenem-Resistant Enterobacterales
To evaluate the efficacy of probiotic preparations as adjunctive therapy for the decolonization of intestinal carbapenem-resistant organisms (CRO), in comparison with conventional antibiotic therapy alone, with the primary…
- Trial name
- NCT07707869
- Testing
- Probiotic Preparation, Conventional Antibiotic
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Liver Transplant, Carbapenem-resistant Enterobacterales
Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase Producing Enterobacterales Undergoing Liver Transplantation
This is a multicenter stepped-wedge cluster randomized trial, conducted over a 2-year period at three hospitals. The trial is structured into four phases, each lasting six months.
- Conditions
- Liver Transplant, Carbapenem-resistant Enterobacterales, CRE Colonization
- Trial name
- TAILOR (NCT07759453)
- Testing
- Ceftazidime - Avibactam ( CAZ-AVI), Meropenem-Vaborbactam, Imipenem+Relebactam
- Where
- 3 sites in Italy
- Volunteers
- 168 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Carbapenem-Resistant Enterobacteriaceae Infection, Bloodstream Infection
Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
Enterobacterales resistant to carbapenem are cause of severe concern in hospital-acquired infections since therapeutic options are limited.
- Trial name
- ABOVE (NCT04876430)
- Testing
- Meropenem
- Where
- 2 sites in Brazil
- Volunteers
- 13 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Carbapenem-Resistant Enterobacteriaceae, Colonisation
Tackling Resistance And HealthCare Economics Through CPE Screening
The goal of this clinical study is to learn if it is possible to reduce the spread of resistant bacteria called CPEs (Carbapenemase producing Enterobacterales) between patients admitted to hospital.
- Trial name
- TRACE-CPE (NCT07663110)
- Testing
- Rapid molecular diagnostic test for CPE identification
- Where
- 2 sites in United Kingdom
- Volunteers
- 16,000 people
- Sponsor
- Imperial College London
Carbapenem-Resistant Enterobacteriaceae Infection
Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales
Severe infections caused by carbapenem-resistant Enterobacterales (CRE) represent a challenge for the clinicians, considering the high mortality rate of these infections.
- Trial name
- MICE (NCT07160569)
- Testing
- Whole Genome Sequencing (WGS), Sequence Type Analysis (ST)
- Where
- 4 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS