Clinical trials: Ventilator-acquired Pneumonia
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
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.
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
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
Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2)
This study aims to compare treatment with Imipenem/Cilastatin-XNW4107 (IMI-XNW4107) with imipenem/cilastatin/relebactam (IMI/REL) in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VAPB…
- Trial name
- REITAB-2 (NCT05204563)
- Testing
- Combination of Imipenem/Cilastatin and XNW4107, Imipenem/Cilastatin/Relebactam
- Where
- 35 sites in United States, France and 2 more
- Volunteers
- 450 people
- Sponsor
- Evopoint Biosciences Inc.
Ventilator Associated Pneumonia
Optimal Endotracheal Cuff Pressure During Hospitalization in Intensive Care Units Using AnapnoGuard 100 System
Hospitech Respiration Ltd has developed the AnapnoGuard system, an innovative system intended to enhance optimal endotracheal tube (ETT) cuff inflation, by monitoring carbon dioxide (CO2) in upper airways of mechanically…
- Trial name
- NCT01188122
- Testing
- AnapnoGuard 100
- Where
- Romania
- Volunteers
- 12 people
- Sponsor
- Hospitech Respiration
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.
Ventilator-Associated Pneumonia (VAP)
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia
This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of…
- Trial name
- NCT01853982
- Testing
- Ceftolozane/Tazobactam, Piperacillin/Tazobactam
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 4 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
COVID-19 Pneumonia, COVID-19
Safety of Nebulized Combination Therapy BromAc® in COVID-19 Respiratory Disease
COVID-19 has multiple facets including cytokine storm, thromboembolism and gelatinous secretions. It is known that oxygen exchange is the main problem in patients with COVID-19 and hypoxia is one of the most serious, in which…
- Conditions
- COVID-19 Pneumonia, COVID-19, Ventilator Associated Pneumonia, COVID-19 Acute Respiratory Distress Syndrome
- Trial name
- NCT05258682
- Testing
- Bromelains, Acetylcysteine
- Volunteers
- 30 people
- Sponsor
- Mucpharm Pty Ltd
Ventilator Associated Pneumonia, Staphylococcus Aureus
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
- Trial name
- SAATELLITE-2 (NCT05331885)
- Testing
- Suvratoxumab
- Where
- 27 sites in Belgium, France and 4 more
- Volunteers
- 24 people
- Sponsor
- Aridis Pharmaceuticals, Inc.
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
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.
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.
Pneumonia, Ventilator-Associated
Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus
Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours.
- Trial name
- NCT00572559
- Testing
- Vancomycin, Linezolid
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 149 people
- Sponsor
- Pfizer
Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP)
Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia…
- Conditions
- Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)
- Trial name
- APEKS-NP (NCT03032380)
- Testing
- Cefiderocol, Meropenem, Linezolid
- Where
- 119 sites in United States, Belgium and 17 more
- Volunteers
- 300 people
- Sponsor
- Shionogi
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
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
Methicillin-Resistant Staphylococcus Aureus (MRSA), Hospital-Acquired Pneumonia
Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference…
- Trial name
- NCT01561469
- Testing
- Linezolid, Vancomycin
- Volunteers
- 188 people
- Sponsor
- Pfizer
Pseudomonas Aeruginosa, Ventilator Associated Pneumonia
Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals.
- Trial name
- NCT00691587
- Testing
- KB001
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Humanigen, Inc.
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.