Clinical trials: Carbapenem Resistant Bacterial Infection
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
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
Carbapenem Resistant Bacterial Infection, Acinetobacter Baumannii Infection
Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation
This study aims to compare 28-day mortality among patients with carbapenem resistant A. baumannii infections in two hypothetical target trials where patients receive 7 days of a cefiderocol-based treatment strategy or 7 days of a…
- Conditions
- Carbapenem Resistant Bacterial Infection, Acinetobacter Baumannii Infection, Antimicrobial Drug Resistance
- Trial name
- NCT07226557
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Carbapenem Resistant Bacterial Infection, Acinetobacter Bacteremia
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii
Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will…
- Conditions
- Carbapenem Resistant Bacterial Infection, Acinetobacter Bacteremia, Acinetobacter Pneumonia
- Trial name
- CASCADE (NCT05922124)
- Testing
- Cefiderocol, Ampicillin-sulbactam, Colistin
- Where
- 3 sites in Israel
- Volunteers
- 734 people
- Sponsor
- Rambam Health Care Campus
Lung Infection Bacterial
Polycolistin E Sodium Mesylate Combined With Intravenous Atomization for Carbapenem Resistant Gram-negative Bacteria in Pulmonary Infection
Pulmonary infection is a kind of infectious disease that seriously damages human health. It usually starts quickly and progresses rapidly in clinical manifestations, and is often accompanied by upper respiratory tract infection…
- Trial name
- NCT06907069
- Testing
- Intravenously atomized polycolistin E sodium mesylate
- Where
- China
- Volunteers
- 200 people
- Sponsor
- First Affiliated Hospital of Ningbo University
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
Ceftazidime-avibactam, Aztreonam
Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB
Metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), due to their capacity to hydrolyze almost all β-lactam antibiotics, have become a critical global threat in antimicrobial resistance.
- Conditions
- Ceftazidime-avibactam, Aztreonam, Gram-negative Bacterial Infection, Metallo-β-lactamase-producing
- Trial name
- NCT07478484
- Testing
- ceftazidime-avibactam combined with aztreonam
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Jing Zhou
Severe Sepsis, Carbapenem Resistant Bacterial Infection
Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients
This prospective observational study is conducted at the First Affiliated Hospital of Zhejiang University School of Medicine from June 1, 2021 to January 1, 2024.
- Trial name
- NCT05413343
- Testing
- Ceftazidime-avibactam
- Where
- China
- Volunteers
- 33 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Drug Resistance, Microbial
Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria
Carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria. Infections due to gram-negative bacteria which have acquired resistance to carbapenems are increasing, especially with Klebsiella pneumoniae…
- Trial name
- NCT01041716
- Testing
- None - Observational study
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Maimonides Medical Center
Gram-Negative Bacterial Infections
Feasibility Studies to Inform Novel Proposals to Avert Community-Based Antimicrobial Resistance Spread
There are many bacteria that naturally live in our gut and are essential for good health. These bacteria have a variety of helpful functions, such as aiding digestion, synthesizing vitamins, repressing the growth of harmful…
- Trial name
- NCT02666274
- Where
- United Kingdom
- Volunteers
- 45 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
This was a Phase 3 study containing a randomized open-label superiority cohort (Cohort 1) comparing the efficacy and safety of plazomicin with colistin when combined with a second antibiotic (either meropenem or tigecycline) in…
- Conditions
- Bloodstream Infections (BSI) Due to CRE, Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE, Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE, Complicated Urinary Tract Infection (cUTI) Due to CRE
- Trial name
- CARE (NCT01970371)
- Testing
- plazomicin, colistin, meropenem
- Volunteers
- 69 people
- Sponsor
- Achaogen, 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
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
Bacteremia Caused by Gram-Negative Bacteria, Bacterial Pneumonia
A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection
This is a retrospective, observational, post-marketing study to evaluate the clinical response, microbiological response, mortality, and safety of intravenous polymyxin B and colistin methanesulfonate in patients with…
- Trial name
- NCT06966284
- Where
- Taiwan
- Volunteers
- 480 people
- Sponsor
- TTY Biopharm
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
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
Urinary Tract Infection, Complicated, Acute Pyelonephritis
Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
A multi-center, retrospective study of cases of serious bacterial infections including complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP), Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Acquired…
- Conditions
- Urinary Tract Infection, Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02420366
- Where
- 22 sites in United States, Greece and 2 more
- Volunteers
- 257 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Mental Health Issue
A Clinical Trial for the Treatment of Carbapenem Resistant Gram-negative Bacterial Infection With Colistimethate Sodium for Injection
A clinical study to evaluate Colistimethate Sodium for Injection combination with Meropenem versus Coly-Mycin® M Parenteral combined with Meropenem in the treatment of Carbapenem resistant gram-negative bacteria infection.
- Trial name
- NCT06198764
- Testing
- Colistimethate sodium for injection, Meropenem for Injection, Coly Mycin M Injectable Product
- Where
- 32 sites in China
- Volunteers
- 80 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Ventilator Associated Pneumonia
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
A multicenter Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B in adult patients with VABP suspected or confirmed to be due to CRAB
- Trial name
- NCT05685615
- Testing
- BV100 plus Polymyxin B, BAT
- Where
- 16 sites in Georgia, Greece and 1 more
- Volunteers
- 39 people
- Sponsor
- BioVersys AG
Acinetobacter Infections
Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Carbapenem-Resistant A. Baumannii Infection
Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients.
- Trial name
- NCT05586815
- Testing
- Colistin, Minocycline
- Where
- Thailand
- Volunteers
- 94 people
- Sponsor
- Mahidol University