Trials / Completed
CompletedNCT03687255
Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
A Phase 3, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Cefepime-AAI101 Compared to Piperacillin/Tazobactam in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,043 (actual)
- Sponsor
- Allecra · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Multi-center, randomized, double-blind, non-inferiority study of cefepime 2 g/AAI101 500 mg combination compared to piperacillin 4 g/tazobactam 500 mg in a population of adult patients with cUTI or AP. The study will be conducted in approximately 115 sites located in the EU, the US, Central, South America and South Africa.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cefepime/AAI101 combination | cefepime 2 g / AAI101 500 mg |
| DRUG | Piperacillin/tazobactam | piperacillin 4 GM / tazobactam 500 MG |
Timeline
- Start date
- 2018-09-24
- Primary completion
- 2020-01-30
- Completion
- 2020-02-15
- First posted
- 2018-09-27
- Last updated
- 2020-03-10
Locations
24 sites across 19 countries: United States, Argentina, Belarus, Bulgaria, Croatia, Estonia, Georgia, Hungary, Latvia, Lithuania, Mexico, Peru, Poland, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03687255. Inclusion in this directory is not an endorsement.