Trials / Completed
CompletedNCT02714595
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients with either hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), complicated urinary tract infection (cUTI), or bloodstream infections (BSI)/sepsis caused by carbapenem-resistant Gram-negative pathogens.
Conditions
- Healthcare-associated Pneumonia (HCAP)
- Bloodstream Infections (BSI)
- Hospital Acquired Pneumonia (HAP)
- Complicated Urinary Tract Infection (cUTI)
- Sepsis
- Ventilator Associated Pneumonia (VAP)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cefiderocol | 2 g intravenously over 3 hours every 8 hours for a period of 7 to 14 days, or 2 g every 6 hours for participants with creatinine clearance \>120 mL/min. |
| DRUG | Best Available Therapy | Standard of care with either a polymyxin-based or non-polymyxin-based regimen as determined by the investigator and consisting of one to three marketed antibacterial agent(s). |
Timeline
- Start date
- 2016-09-07
- Primary completion
- 2019-04-01
- Completion
- 2019-04-22
- First posted
- 2016-03-21
- Last updated
- 2021-01-12
- Results posted
- 2020-12-17
Locations
85 sites across 16 countries: United States, Brazil, Croatia, France, Germany, Greece, Guatemala, Israel, Italy, Japan, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02714595. Inclusion in this directory is not an endorsement.