Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398411
Status:
COMPLETED
Last Update Posted:
2015-06-29
First Post:
2006-11-08
Brief Title:
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Double-blind Randomized Mono-center Placebo-controlled Pilot Study to Investigate the Efficacy and Safety of Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MoxiProph
Brief Summary:
This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia
Further investigations include time to occurrence of fever duration of fever overall survival and antibiotic sensitivity of blood isolates
Further investigations include time to occurrence of fever duration of fever overall survival and antibiotic sensitivity of blood isolates
Detailed Description:
Because fluoroquinolones have broad antimicrobial coverage bactericidal activity high tissue concentrations oral bioavailability and adequate tolerability and safety profiles they are ideal candidates as antibacterial prophylaxis in cancer patients Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated Moxifloxacin may be another promising alternative covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily thus optimizing compliance a crucial issue in prophylaxis
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-003271-21 | EUDRACT_NUMBER | None | None |