Clinical trials: Ventilator Associated Bacterial Pneumonia (VABP)
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 Baumannii-calcoaceticus Complex Infection (ABC)
A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
The goal of this observational study is to evaluate the safety of sulbactam-durlobactam, as well as the risk of hypersensitivity reactions (including anaphylaxis) in participants with Acinetobacter baumannii-calcoaceticus complex…
- Trial name
- NCT06746883
- Testing
- Non-interventional
- Where
- 12 sites in United States
- Volunteers
- 100 people
- Sponsor
- Innoviva Specialty Therapeutics
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
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.
Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC)
A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
The goal of this clinical trial is to investigate the use of Sulbactam-Durlobactam (SUL-DUR) in pediatric patients and is being conducted to collect pharmacokinetic (PK) and safety data to enable the identification of appropriate…
- Trial name
- NCT06801223
- Testing
- Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours), Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours)
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- Innoviva Specialty Therapeutics
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
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.
Bacterial Pneumonia
Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
This study aims to compare treatment with a fixed-dose combination (FDC) of imipenem/relebactam/cilastatin (IMI/REL) with a FDC of piperacillin/tazobactam (PIP/TAZ) in participants with hospital-acquired or ventilator-associated…
- Trial name
- RESTORE-IMI 2 (NCT02493764)
- Testing
- Imipenem, Relebactam, Cilastatin
- Volunteers
- 537 people
- Sponsor
- Merck Sharp & Dohme LLC
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 Bacterial Pneumonia, Pseudomonas Aeruginosa Infection
A Double-Blind, Placebo-Controlled Study of Nebulized Bacteriophages in Patients With Ventilator-Associated Pneumonia Due to Pseudomonas Aeruginosa
Ventilator-associated pneumonia (VAP) complicates the hospital course of up to 40% of mechanically ventilated patients and is associated with mortality rates approaching 30%, despite appropriate antibiotic therapy (ATB).
- Trial name
- PYOPHANEB (NCT07804082)
- Testing
- Bacteriophages GMP
- Where
- 16 sites in France
- Volunteers
- 184 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Oropharyngeal Aspiration to Reduce Ventilator-Related Pneumonia
Ventilator-associated pneumonia (VAP) is one of the healthcare-related infections that is common in critically ill patients, prolongs hospital stay, significantly increases mortality and additional health care costs.
- Trial name
- NCT04107363
- Testing
- Oropharyngeal aspiration before changing the position of the patient, Control group:
- Volunteers
- 40 people
- Sponsor
- Ayşe AKBIYIK
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, Ventilator-Associated Bacterial Pneumonia
A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
The purpose of this study is to determine the efficacy, safety, tolerability, and pharmacokinetics (PK) of meropenem-vaborbactam compared to piperacillin/tazobactam for 7 to 14 days in the treatment of hospitalized adults who…
- Conditions
- Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia, Hospital-Acquired Pneumonia, Ventilator-Associated Pneumonia
- Trial name
- TANGOIII (NCT03006679)
- Testing
- Meropenem-Vaborbactam, Piperacillin/Tazobactam
- Sponsor
- Melinta Therapeutics, Inc.
Pneumonia
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas…
- Trial name
- PRISM-MDR (NCT03409679)
- Testing
- Murepavadin, Two anti-pseudomonal antibiotics
- Where
- 61 sites in United States, Brazil and 11 more
- Volunteers
- 41 people
- Sponsor
- Polyphor Ltd.
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
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, Mechanical Ventilation Complication
The Effect of Ulinastatin on Bronchoalveolar Lavage Fluid of Inflammatory Factors in Patients With Ventilator-associated Pneumonia
Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in ventilated critically ill patients specially in intensive care unit (ICU).
- Trial name
- NCT01865266
- Testing
- Ulinaststin for injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai Minhang Central Hospital
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
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.