Clinical trials: Carbapenemase-producing Enterobacteriaceae Infections
Clinically Significant Bacteremia, Organ Transplantation
Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
Main objective: to observationally assess the efficacy and safety of different antimicrobials in BSI due to ESBL or carbapenemase-producing Enterobacterales in SOT. Secondary objectives: 1.
- Conditions
- Clinically Significant Bacteremia, Organ Transplantation, Infection, Bacteremia
- Trial name
- INCREMENT-SOT (NCT02852902)
- Where
- 3 sites in Spain
- Volunteers
- 820 people
- Sponsor
- Spanish Network for Research in Infectious Diseases
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
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
Carbapenem Resistant Bacteria Infection
European Prospective Cohort Study on Enterobacteriaceae Showing Resistance to Carbapenems
Among antibiotic-resistant organisms, the Gram-negative bacteria are now the most important challenge because of the rapid worldwide spread of mechanisms conferring resistance to multiple drugs.
- Trial name
- EURECA (NCT02709408)
- Where
- 50 sites in Albania, Bulgaria and 9 more
- Volunteers
- 2,515 people
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Multidrug-resistant organisms (MDROs) cause serious infections that are difficult to treat, leading to increased morbidity and mortality, longer hospital stays, and increased healthcare costs.
- Conditions
- Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococci, Carbapenem-Resistant Enterobacteriaceae
- Trial name
- MDRO-Fiber (NCT07792915)
- Testing
- Resistant Potato Starch, Maltodextrin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- VA Office of Research and Development
Carbapenem-Resistant Enterobacteriaceae Infection
Oral Capsule Faecal Microbiota Transplantation for CPE Decolonization
Double-blinded, randomised controlled trial to evaluate the clinical efficacy of a single dose of oral capsule-administered faecal microbiota transplantation (FMT) for carbapenemase-producing Enterobacteriaceae (CPE) intestinal…
- Trial name
- NCT04746222
- Testing
- Oral capsule faecal microbiota transplantation
- Volunteers
- 108 people
- Sponsor
- Tan Tock Seng Hospital
Bacteremia, Enterobacteriaceae Infections
Ultra Rapid Culture Independent Detection of High-Priority Carbapenem Resistant Enterobacteriaceae Directly From Blood
The purpose of this study is to develop a new and very rapid diagnostic test for identifying a certain type of bacteria called Enterobacteriaceae in blood.
- Trial name
- NCT02482051
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Denver Health and Hospital Authority
Clostridium Difficile Infection
Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients
Vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE) are multi-drug resistant organisms (MDROs) associated with healthcare settings and are a high priority for containment in public health.
- Trial name
- NCT03643887
- Testing
- FMT Capsule DE
- Sponsor
- University of Wisconsin, Madison
Carbapenem-Resistant Enterobacteriaceae Infection, KPC
Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections
This is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing…
- Conditions
- Carbapenem-Resistant Enterobacteriaceae Infection, KPC, Gram-Negative Bacterial Infections, Antibiotic Resistant Infection
- Trial name
- NCT04785924
- Testing
- Imipenem+Relebactam
- Where
- United States
- Sponsor
- Wake Forest University Health Sciences
Enterobacteriaceae Infections
Prevalence of ESBL and CPE in French Nursing Homes
CARBEHPAD is a multicentric randomized prevalence study aiming to assess the frequency of Enterobacteriaceae (ESLB) and carbapenemase producing Enterobacteriaceae (CPE) carriage in Pays de la Loire nursing homes.
- Trial name
- CARBEHPAD (NCT03401242)
- Where
- France
- Volunteers
- 734 people, healthy volunteers welcome
- Sponsor
- Nantes University Hospital
Crohn Disease, Ulcerative Colitis
Safety and Efficacy of Fecal Microbiota Transplantation
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease…
- Conditions
- Crohn Disease, Ulcerative Colitis, Celiac Disease, Irritable Bowel Syndrome
- Trial name
- NCT04014413
- Testing
- Fecal Microbiota Transplantation
- Where
- Hong Kong
- Volunteers
- 450 people
- Sponsor
- Chinese University of Hong Kong
Septic Shock
Pentaglobin in CRE and PA Neutropenic Infections
To demonstrate that the early addition of Pentaglobin to the best available antimicrobial therapy is able to reduce mortality and improve survival in neutropenic febrile acute leukemia or allo- Hematopoietic stem cell…
- Trial name
- PENTALLO (NCT03494959)
- Testing
- Pentaglobin
- Where
- 20 sites in Italy
- Volunteers
- 120 people
- Sponsor
- Gruppo Italiano Trapianto di Midollo Osseo
Carbapenemase-Producing Enterobacteriaceae
Incidence and Risk Factors for Developing Infections in Patients Colonized by CP-KPC
The worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem.
- Trial name
- KPC (NCT05492539)
- Where
- Argentina
- Volunteers
- 500 people
- Sponsor
- Hospital Italiano de Buenos Aires
Enterobacteriaceae Infections, Fecal Microbiota Transplantation
Pilot Study Using Oral Capsule FMT to Decolonize GI CRE
Carbapenem-Resistant Enterobacteriaceae (CRE) are bacteria that have become resistant to carbapenems by producing enzymes that break down carbapenems.
- Trial name
- NCT03527056
- Testing
- Fecal Microbiota Transplantation
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Antibiotic Resistance, Enterobacteriaceae Infections
Genomic and Phenotypic Diversity of Carbapenemase-producing Escherichia Coli Strains Circulating in Southern France
Carbapenemase-producing Enterobacteriaceae (CPE) are classified as emerging Highly Resistant Bacteria (eHRB) because they expose infected patients to the risk of treatment failure due to the strains' resistance to last-line…
- Conditions
- Antibiotic Resistance, Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection, Colonization
- Trial name
- CARBACOLI (NCT07676513)
- Testing
- MultiLocus Sequence Typing
- Where
- France
- Volunteers
- 163 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Carbapenem-Resistant Enterobacteriaceae Infection, Bloodstream Infection
Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections
Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the…
- Conditions
- Carbapenem-Resistant Enterobacteriaceae Infection, Bloodstream Infection, Severe Infection, Pseudomonas Aeruginosa
- Trial name
- OPTIMISE (NCT05210387)
- Testing
- Duration of therapy
- Where
- 29 sites in Brazil
- Volunteers
- 107 people
- Sponsor
- Hospital Moinhos de Vento
Carbapenem-Resistant Enterobacteriaceae Infection
Impact of Ceftazidime / Avibactam Treatment vs Better Available Therapy on Mortality of Patients With Infections Caused by Carbapenem-resistant Enterobacteria
Patients with infections caused by carbapenem-resistant enterobacteria treated with CAZ-AVI versus patients treated with BAT are compared. The BAT group includes fosfomycin, tigecycline, gentamicin, meropenem and colistin.
- Trial name
- CAVICOR (NCT04167228)
- Testing
- Ceftazidime-Avibactam, Best Available Therapy
- Where
- 17 sites in Spain
- Volunteers
- 348 people
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Carbapenem-Resistant Enterobacteriaceae
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase…
- Trial name
- NCT03680898
- Testing
- Rectal swab collection
- Where
- 3 sites in United States, Canada
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
Enterobacteriaceae Infections, Multi-antibiotic Resistance
FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae
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
- FMT-CRE (NCT04759001)
- Testing
- Donor FMT
- Where
- Italy
- Volunteers
- 52 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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