Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-11 @ 11:44 PM
Study NCT ID:
NCT01496794
Status:
TERMINATED
Last Update Posted:
2017-02-23
First Post:
2011-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endophthalmitis Cultures
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
Prospective Surveillance of Patients With Endophthalmitis for Multi-antibiotic Resistance (PROSPER) Study
Status:
TERMINATED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSPER
Brief Summary:
The intent of this surveillance study will be to obtain written permission from patients with bacterial endophthalmitis in order to compare sterilization rates of their cultured bacterial isolates to standard therapy (vancomycin and ceftazidime) versus combination therapy with vancomycin, ceftazidime, and moxifloxacin.
Research hypothesis:
1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to "standard therapy" with vancomycin and ceftazidime.
2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing rates of multi-antibiotic resistance.
Research hypothesis:
1. Cultured bacterial isolates will demonstrate faster in vitro sterilization rates with combination treatment (vancomycin, ceftazidime, and moxifloxacin) compared to "standard therapy" with vancomycin and ceftazidime.
2. Longitudinal analysis of resistance patterns of cultured isolates will show increasing rates of multi-antibiotic resistance.
Detailed Description:
Adult patients over 18 years of age presenting with endophthalmitis and able to sign consent.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: