Clinical trials: Carbapenems
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
Urinary Tract Infection, Acute Pyelonephritis
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults
This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types…
- Conditions
- Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia
- Trial name
- NCT04882085
- Testing
- Zavicefta, Ceftazidime-Avibactam, Best Available Treatment
- Where
- 37 sites in China
- Volunteers
- 60 people
- Sponsor
- Pfizer
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.
Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized…
- Trial name
- VITORA (NCT03944369)
- Testing
- KB109, No intervention
- Where
- 8 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kaleido Biosciences
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.
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.)
Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP)
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections.
- Conditions
- Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP), Blood Stream Infection, Meningitis, Bacterial
- Trial name
- RIV- CARE (NCT07431307)
- Testing
- BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT)
- Volunteers
- 120 people
- Sponsor
- BioVersys AG
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.
Pneumonia, Pneumonia, Ventilator-Associated
PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.
- Conditions
- Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections
- Trial name
- NCT00986102
- Testing
- doripenem
- Where
- 16 sites in Hong Kong, Indonesia and 3 more
- Volunteers
- 216 people
- Sponsor
- Janssen Research & Development, LLC
Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative…
- Trial name
- NCT07512596
- Testing
- TQD3524, Meropenem for injection, Colistimethate Sodium for Injection
- Where
- 27 sites in China
- Volunteers
- 48 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
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.
Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI)
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
- Conditions
- Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI)
- Trial name
- CREDIBLE - CR (NCT02714595)
- Testing
- Cefiderocol, Best Available Therapy
- Where
- 85 sites in United States, Brazil and 14 more
- Volunteers
- 152 people
- Sponsor
- Shionogi
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections.
- Conditions
- Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI)
- Trial name
- NCT07089186
- Testing
- Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia
Real-World Study of Ceftazidime Avibactam in China
This observational study will enroll approximately 450 in patients. Patients treated with CAZ AVI for at least 1 dose at around 20 research centers in China will be enroll.
- Conditions
- Hospital Acquired Pneumonia, Ventilator Acquired Pneumonia, Complicated Intra Abdominal Infections
- Trial name
- REACT (NCT05487586)
- Testing
- ceftazidime avibactam group
- Where
- 17 sites in China
- Volunteers
- 220 people
- Sponsor
- Pfizer
VRE Colonization, CRE Colonization
Human Clinical Trial to Evaluate the Decolonization Efficacy of BM111 Against Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococcus (VRE)
A clinical study to eliminate intestinal colonization in subjects harboring microorganisms resistant to carbapenem and vancomycin antibiotics, thereby treating infections caused by these microorganisms.
- Trial name
- NCT07525089
- Testing
- BM111
- Where
- South Korea
- Volunteers
- 38 people
- Sponsor
- BioMe Inc.
Urinary Tract Infection Complicated, Acute Pyelonephritis
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
Vabomere™, (meropenem-vaborbactam) is being compared to the Best Available Therapy in the treatment of adults with selected serious infections due to Carbapenem Resistant Enterobacteriaceae
- Conditions
- Urinary Tract Infection Complicated, Acute Pyelonephritis, Hospital Acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
- Trial name
- NCT02168946
- Testing
- Vabomere, Best Available Therapy
- Where
- 50 sites in United States, Argentina and 6 more
- Volunteers
- 77 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
This is a two-part study, with Part A being the randomized, controlled portion of the study in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) suspected or confirmed…
- Conditions
- Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP), Colistin Resistanrt ABC, Acinetobacter Baumannii-calcoaceticus Complex
- Trial name
- RIV-TARGET (NCT07326540)
- Testing
- BV100 (300 mg), Polymyxin B, Colistin
- Where
- Georgia
- Volunteers
- 248 people
- Sponsor
- BioVersys SAS