Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)
Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Unknown status
CT.gov ID
NCT00215007
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of levofloxacin to prevent bacterial infections in the postneutropenic period in patients who have undergone allogeneic stem cell transplantation (SCT).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Allogeneic SCT
-
Postneutropenic period
-
Written consent
Exclusion Criteria:
-
Fever
-
Antibiotic therapy
-
Neutropenia
-
Refusal by the patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charite, CBF | Berlin | Germany | 12200 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Study Chair: Igor Wolfgang Blau, Dr., Charite, CBF, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00215007
Other Study ID Numbers:
- Levosta-CBF-02/04
First Posted:
Sep 22, 2005
Last Update Posted:
Nov 30, 2007
Last Verified:
Feb 1, 2004