Clinical trials: Hospital Acquired Infection
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
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
Infection in ICU
Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients
Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients. A prospective, observational, multicenter study (ANTHICUS).
- Trial name
- ANTHICUS (NCT00543894)
- Volunteers
- 500 people
- Sponsor
- AstraZeneca
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Pneumonia
Ceftobiprole in Hospital Acquired Pneumonia
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug [form] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with…
- Trial name
- NCT00210964
- Testing
- linezolid plus ceftazidime
- Volunteers
- 781 people
- Sponsor
- Basilea Pharmaceutica
Pneumonia, Ventilator Associated Pneumonia
Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas Aeruginosa
The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of…
- Trial name
- NCT00851435
- Testing
- KBPA-101
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Kenta Biotech Ltd
Nosocomial Infection, Diarrhea, Infantile
Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children
One of the most common infections acquired in hospital, also known as nosocomial infections, is intestinal infections. These infections can lead to the development of nosocomial diarrhea which can have serious consequences in…
- Trial name
- EPISODE (NCT04628819)
- Where
- 2 sites in France
- Volunteers
- 61 people
- Sponsor
- PiLeJe
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.
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
Community-acquired Pneumonia (CAP), Hospital-acquired Pneumonia (HAP)
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
This was a study of the safety and efficacy of ceftobiprole medocaril compared with intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in pediatric patients with either hospital-acquired…
- Trial name
- NCT03439124
- Testing
- ceftobiprole medocaril, IV standard-of-care cephalosporin
- Where
- 19 sites in Bulgaria, Georgia and 2 more
- Volunteers
- 138 people
- Sponsor
- Basilea Pharmaceutica
Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
The purpose of this study is to learn about the safety and effectiveness of Zavicefta once released into the markets in Korea. This study is to learn about Zavicefta in patients with difficult types of infections in the abdomen…
- Conditions
- Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia
- Trial name
- NCT05733104
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Pfizer
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
Pneumonia
Doripenem in the Treatment of Hospital-Acquired Pneumonia
The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).
- Trial name
- NCT00211003
- Testing
- doripenem
- Volunteers
- 240 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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
Bacterial Pneumonia
Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia
To compare the efficacy and safety of the tigecycline regimen with that of the imipenem/cilastatin regimen in subjects with nosocomial pneumonia.
- Trial name
- NCT00080496
- Testing
- Tigecycline, Imipenem, Cilastatin
- Where
- 29 sites in United States
- Volunteers
- 430 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Nosocomial Infections, Pneumonia, Ventilator-Associated
A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in…
- Trial name
- NCT02756351
- Testing
- CytaCoat Nasal Prong, Inspiration Healthcare Inspire nCPAP Nasal Prong
- Where
- Sweden
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- CytaCoat AB
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.