Clinical trials: Hospital-acquired Bacterial Pneumonia (HABP)
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 Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
This is a Phase 3, randomized, double-blind, multicenter, comparative study evaluating cefepime-zidebactam (FEP-ZID) versus ceftazidime-avibactam (CAZ-AVI) with or without colistin in the treatment of adults with…
- Trial name
- NCT07885891
- Testing
- Cefepime-Zidebactam, Ceftazidime-avibactam with or without Colistin
- Where
- 55 sites in Bosnia and Herzegovina, Bulgaria and 12 more
- Volunteers
- 324 people
- Sponsor
- Wockhardt
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
A Clinical Study of YK-1169 Versus Ceftazidime-Avibactam in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
To evaluate the all-cause mortality rate at Day 28 in the YK-1169 group versus the ceftazidime-avibatan injection group in the mITT population.
- Trial name
- NCT07634198
- Testing
- YK-1169, Ceftazidime-avibactam Injection
- Volunteers
- 590 people
- Sponsor
- Nanjing Yoko Biomedical Co., Ltd.
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and…
- Trial name
- NCT07327619
- Testing
- Meropenem and Pralurbactam, Ceftazidime-avibactam
- Where
- China
- Volunteers
- 420 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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.
Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator…
- Trial name
- NCT06087536
- Testing
- OMN6
- Where
- 15 sites in Greece, Israel
- Volunteers
- 54 people
- Sponsor
- Omnix Medical Ltd
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
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
Ventilator-associated Bacterial Pneumonia (VABP), Hospital-acquired Bacterial Pneumonia (HABP)
ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
This is a randomized, active-controlled, multicenter phase II clinical trial. The study aims to evaluate the efficacy, safety and tolerability of two different dosing regimens of ASK0912 for Injection compared with Polymyxin B…
- Trial name
- NCT07759934
- Testing
- ASK0912 for Injection, Polymyxin B Sulfate for Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP)
A Trial of HRS-8427 in the Treatment of Adults With Bacterial Pneumonia
The purpose of this study is to evaluate the efficacy and safety of HRS -8427 in patients with HABP/VABP.
- Trial name
- NCT06841731
- Testing
- HRS-8427, Meropenem
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pneumonia, Ventilator-Associated, Pneumonia, Bacterial
CTTI Risk Factors for HABP/VABP Study
The purpose of this study is to better define the intensive care unit population at highest risk for developing Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP).
- Conditions
- Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Pneumonia, Hospital-Acquired
- Trial name
- PROPHETIC (NCT02689531)
- Where
- 15 sites in United States
- Volunteers
- 7,530 people
- Sponsor
- Duke University
Ventilator-associated Pneumonia, Hospital-acquired Pneumonia
Cefepime-taniborbactam vs Meropenem in Adults With VABP or Ventilated HABP
This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.
- Trial name
- CERTAIN-2 (NCT06168734)
- Testing
- Cefepime-taniborbactam, Meropenem
- Sponsor
- Venatorx Pharmaceuticals, Inc.
Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are to assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric participants 3 months to < 12 years of age with…
- Conditions
- Gram-negative Bacterial Infections, Hospital Acquired Bacterial Pneumonia (HABP), Complicated Urinary Tract Infection (cUTI), Ventilator Associated Bacterial Pneumonia (VABP)
- Trial name
- NCT04215991
- Testing
- Cefiderocol, Standard of Care
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 91 people
- Sponsor
- Shionogi