Clinical trials: Complicated Urinary Tract Infection (cUTI)
Complicated Urinary Tract Infection
A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI
This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for…
- Trial name
- NCT05826990
- Testing
- cefepime and enmetazobactam combination
- Where
- 8 sites in Czechia, France and 4 more
- Volunteers
- 40 people
- Sponsor
- Orchid Pharma Europe GmbH
Complicated Urinary Tract Infection, Pyelonephritis
MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.
- Trial name
- NCT03230838
- Testing
- Ceftolozane/Tazobactam, Meropenem
- Where
- 52 sites in United States, Greece and 8 more
- Volunteers
- 134 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
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
Complicated Urinary Tract Infection
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Performance evaluation of QIAstat-Dx cUTI Plus AMR Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user…
- Trial name
- NCT06824129
- Where
- United Kingdom
- Volunteers
- 1,500 people
- Sponsor
- QIAGEN Gaithersburg, Inc