Ignite Creation Date:
2024-05-06 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03697993
Status:
TERMINATED
Last Update Posted:
2020-12-19
First Post:
2018-10-04
Brief Title:
Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes FOCUS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Multi-center Randomized Open-label Trial to Evaluate the Efficacy of Oral Fosfomycin Versus Oral Levofloxacin Strategies in Complicated Urinary Tract Infections FOCUS
Status:
TERMINATED
Status Verified Date:
2018-09-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inadequate enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 4 multi-center open-label randomized pragmatic superiority clinical trial comparing two strategies for initial or step-down oral therapy for complicated urinary tract infections cUTI after 0-48 hours of parenteral antibiotic therapy The trial will evaluate the success and safety of a strategy of initial or step-down fosfomycin administered at a dose of 3 g once daily vs a strategy of initial or step-down levofloxacin administered at a dose of 750 mg once daily Investigator-directed adjustment to another adequate oral therapy is allowed 1 if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy OR 2 if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigators discretion OR 3 the subject has an underlying condition posing increasing risk for adverse events from quinolone therapy The duration of oral therapy initial investigator-directed adjustment if indicated in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible The dosing of oral therapy depends on creatinine clearance CrCl The trial will enroll approximately 634 patients that are either male or female aged 18 or older with cUTI from outpatient and inpatient settings The study will take place over 25 months in up to 15 US sites The primary objective is to compare Strategy 1 and Strategy 2 in terms of treatment success rates at Test of Cure TOC
Detailed Description:
This is a Phase 4 multi-center open-label randomized pragmatic superiority clinical trial comparing two strategies for initial or step-down oral therapy for complicated urinary tract infections cUTI without bacteremia with a uropathogen after 0-48 hours of parenteral antibiotic therapy The trial will evaluate the success and safety of a strategy of initial or step-down fosfomycin administered at a dose of 3 g once daily vs a strategy of initial or step-down levofloxacin administered at a dose of 750 mg once daily Investigator-directed adjustment to another adequate oral therapy is allowed 1 if the causative pathogen is not susceptible in vitro to quinolone initial or step-down therapy in a subject randomized to the levofloxacin strategy OR 2 if the subject develops an intolerance or allergy to the initial step-down oral therapy and at the investigators discretion OR 3 the subject has an underlying condition posing increasing risk for adverse events from quinolone therapy The duration of oral therapy initial subsequent if indicated in each strategy is 5-7 days of any per protocol antibiotic to which the pathogen is susceptible The dosing of oral therapy depends on creatinine clearance CrCl The trial will enroll approximately 634 patients that are either male or female aged 18 or older with cUTI from outpatient and inpatient settings The study will take place over 25 months in up to 15 US sites The primary objective is to compare Strategy 1 and Strategy 2 in terms of treatment success rates at Test of Cure TOC The secondary objectives are 1 to assess the safety of Fosfomycin 2 to compare Strategy 1 and Strategy 2 in terms of solicited adverse events 3 to compare Strategy 1 and Strategy 2 in terms of treatment success rates at End of Therapy EOT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN272201300018I | None | None | None |