Clinical trials: Ventilators
Bronchopulmonary Dysplasia
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham…
- Trial name
- NCT04662151
- Testing
- AT-100
- Where
- 19 sites in United States, Spain
- Volunteers
- 37 people
- Sponsor
- Airway Therapeutics, Inc.
Pneumonia, Ventilator-Associated
Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia
Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy…
- Trial name
- RECOVER (NCT06370598)
- Testing
- TP-122A
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Technophage, SA
Pneumonia
Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of…
- Trial name
- NCT00050401
- Testing
- MERREM I.V. 2g as a 3 hour infusion every 8 hours, vancomycin I.V. 1 g every 12 hours, tobramycin I.V. 5 mg/kg every 24 hours
- Where
- 10 sites in United States
- Volunteers
- 500 people
- Sponsor
- Pfizer
Ventilator Induced Diaphragmatic Dysfunction (VIDD)
PEPNS System Feasibility Study
The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).
- Trial name
- NCT03559933
- Testing
- PEPNS System
- Where
- 2 sites in Czechia, Ireland
- Volunteers
- 12 people
- Sponsor
- Stimdia Medical Inc.
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United 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
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, Acute Respiratory Distress Syndrome
Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite
This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of intravenous Sodium Nitrite Injection for treatment of patients infected with COVID-19 who develop lung injury…
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- Trial name
- NCT04401527
- Testing
- Sodium Nitrite, Normal Saline
- Where
- 2 sites in United States
- Sponsor
- Hope Pharmaceuticals
Pneumonia
Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia
This is a multinational, double-blind, placebo-controlled trial designed to assess whether iseganan, applied topically to the oral cavity, can prevent ventilator-associated pneumonia among patients who are intubated and…
- Trial name
- NCT00118781
- Testing
- iseganan hydrochloride
- Where
- United States
- Volunteers
- 900 people
- Sponsor
- IntraBiotics Pharmaceuticals
Hospital Acquired Bacterial Pneumonia, Complicated Skin and Skin Structure Infections
Telavancin Observational Use Registry (TOUR)
The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who…
- Conditions
- Hospital Acquired Bacterial Pneumonia, Complicated Skin and Skin Structure Infections, Ventilator Associated Bacterial Pneumonia, Gram Positive Infection
- Trial name
- TOUR (NCT02288234)
- Testing
- Vibativ
- Where
- United States
- Volunteers
- 1,063 people
- Sponsor
- Cumberland Pharmaceuticals
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.
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
Ventilator Induced Lung Injury
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
- Trial name
- NCT02670460
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Lungpacer Medical Inc.
Wounds and Injuries, Respiratory Failure
FiO2 Closed Loop Control Ventilation
A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 delivery using a continuous…
- Trial name
- CLC (NCT02810080)
- Testing
- Closed Loop Control Ventilation, Manual Control Ventilation
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Zoll Medical Corporation
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
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.
Retinopathy of Prematurity (ROP)
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.
- Trial name
- NCT01096784
- Testing
- rhIGF-I/rhIGFBP-3
- Where
- 24 sites in United States, Italy and 4 more
- Volunteers
- 121 people
- Sponsor
- Shire
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.
COVID-19 Pneumonia, Bromelains Adverse Reaction
Nebulised BromAc in Healthy Volunteers
COVID-19 is a disease that has multiple facets including an inflammatory storm, it promotes blood clotting and causes kidney damage, mucinous secretions in the lung are of great importance to outcome.
- Conditions
- COVID-19 Pneumonia, Bromelains Adverse Reaction, Acetylcysteine Adverse Reaction, Mucus; Plug
- Trial name
- NCT05220605
- Testing
- BromAc
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mucpharm Pty Ltd
Neuromodulation, Phrenic Nerve Stimulation
Randomized Study of the pdSTIM™ System in Failure to Wean Mechanically Ventilated Patients
This prospective, multi-center, randomized, controlled clinical trial is being conducted to evaluate the safety and efficacy of the pdSTIM System to facilitate weaning from mechanical ventilation through phrenic nerve…
- Conditions
- Neuromodulation, Phrenic Nerve Stimulation, Ventilator Induced Diaphragm Dysfunction, Mechanical Ventilation Weaning
- Trial name
- ReInvigorate (NCT05998018)
- Testing
- pdSTIM System Therapy, Conventional Medical Management
- Where
- 16 sites in United States
- Volunteers
- 32 people
- Sponsor
- Stimdia Medical Inc.