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
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
Febrile Neutropenia, Pharmacokinetics
Population Pharmacokinetics/Pharmacodynamics of Carbapenems in Febrile Neutropenia Patients
1. Evaluating the differences in the efficacy and safety of meropenem optimal dosing regimen predicted by the PPK/PD model combined with MAPB method for patients with malignant hematological myelopathy accompanied by fever, as…
- Conditions
- Febrile Neutropenia, Pharmacokinetics, Pharmacodynamic, Carbapenems
- Trial name
- NCT05665478
- Testing
- Dose prediction using population pharmacokinetic models
- Volunteers
- 100 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Infectious Disease
Temocillin in ESBL-Enterobacteriaceae Infections
Because of the increasing incidence of infections with multi-drug resistant enterobacteriaceae, we need alternative treatments to spare carbapenems.
- Trial name
- TMO2016 (NCT05413772)
- Testing
- Temocillin
- Where
- 2 sites in France
- Volunteers
- 29 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sepsis, Septic Shock
Piperacillin-tazobactam and Temocillin as Carbapenem-alternatives for the Treatment of Severe Infections Due to Extended-spectrum Beta-lactamase-Producing Gram-negative Enterobacteriaceae in the Intensive Care Unit
Infections due to extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae are a major public health concern, in particular in the intensive care unit (ICU), due to the increase in their incidence.
- Trial name
- PITAGORE (NCT05565222)
- Testing
- Piperacillin/tazobactam or temocillin, Meropenem
- Where
- 2 sites in France
- Volunteers
- 600 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Carbapenem-Resistant Enterobacteriaceae Infection
Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children
Carbapenem-resistant Enterobacteriaceae (CRE) are increasingly identified in children in China. Pediatric intensive care unit (PICU) is the high-risk area.
- Trial name
- NCT04535661
- Where
- China
- Volunteers
- 536 people
- Sponsor
- Children's Hospital of Fudan University
Antibiotic Therapy
Evaluating a Novel Individualised Treatment Strategy for Carbapenem-Resistant Gram-Negative Bacteria Infections
Carbapenem-resistant (CR) Gram negative bacteria (GNB) - which are resistant to carbapenems (a last-line potent antibiotic with a high therapeutic index) - are also resistant to all other beta-lactam antibiotics.
- Trial name
- NCT04202861
- Testing
- In vitro antibiotic combination testing (iACT)
- Where
- Singapore
- Volunteers
- 594 people
- Sponsor
- Singapore General Hospital
Infection Due to Carbapenem Resistant Acinetobacter
Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand.
- Trial name
- NCT06570850
- Testing
- Colistin Sodium Methanesulfonate, Colistin Sodium Methanesulfonate plus Fosfomycin
- Where
- Thailand
- Volunteers
- 188 people
- Sponsor
- Chiang Mai University
Carbapenem-Resistant Enterobacteriaceae Infection, Pneumonia - Bacterial
Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.
Study Design: A randomized, open-label, parallel-group clinical trial comparing the efficacy and safety of jet nebulization versus vibrating mesh nebulization of sulfate polymyxin B in mechanically ventilated patients with…
- Trial name
- NCT07086391
- Testing
- Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization
- Where
- China
- Volunteers
- 144 people
- Sponsor
- Fujian Medical University Union 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
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, Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)
Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract
The goal of this unblinded randomized controlled trial is to evaluate the efficacy and safety of fecal microbiota transplantation for the decolonization of carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE)…
- Trial name
- NCT06001333
- Testing
- fecal microbiota transplantation
- Where
- 2 sites in South Korea
- Volunteers
- 240 people
- Sponsor
- Chuncheon Sacred Heart Hospital
Staphylococcus Aureus, Carbapenem Resistant Gram Negative Bacteria
Targeted Gown and Glove Intervention in Nursing Homes
This project will assess the feasibility of a cluster-randomized trial with crossover of our intervention, targeted gown and glove use, among high-risk residents of community nursing homes to prevent Staphylococcus aureus and…
- Trial name
- TAGG (NCT04200508)
- Testing
- Targeted gown and gloves use
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Maryland, Baltimore
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
Infection Due to Resistant Organism
FMT for MDRO Colonization After Infection in Renal Transplant Recipients
Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical…
- Trial name
- PREMIX (NCT02922816)
- Testing
- Fecal Microbiota Transplant (FMT), Bowel preparation, Stool or perirectal swab sampling
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Emory University
Carriage of Carbapemen-resistant Klebsialle Pneumoniae
Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae
There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive…
- Trial name
- NCT00753558
- Where
- Israel
- Sponsor
- Soroka University Medical Center
High-dose Biapenem
Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
Carbapenem resistance is a high mortality rate of Klebsiella pneumoniae infection. It has been proved that high-dose carbapenem can reduce mortality and has a certain clinical effect.
- Trial name
- NCT04552444
- Testing
- Biapenem
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Bloodstream Infection
Comparison of Bloodstream Infections With Carbapenem Hetero-resistant vs Carbapenem Resistant Klebsiella Pneumoniae
COMBAT trial was contemplated to elucidate unknown clinical relevance of carbapenem heteroresistance among Klebsiella pneumoniae species.
- Trial name
- COMBAT (NCT04229498)
- Testing
- Monotherapy and combination therapy (all antibiotics that are given by attending pysicians and can be active against Klebsiella pneumoniae will be evaluated)
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- SCARE (Study group for carbapenem resistance)
Obesity
Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.
Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.
- Trial name
- NCT01407965
- Testing
- microdialysis catheter
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- University of Ulm
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.