We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00215007
Recruitment Status : Unknown
Verified February 2004 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : November 30, 2007
Sponsor:
Information provided by:

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
Malignancy Allogeneic Stem Cell Transplantation Drug: Levofloxacin Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allogeneic SCT
  • Postneutropenic period
  • Written consent

Exclusion Criteria:

  • Fever
  • Antibiotic therapy
  • Neutropenia
  • Refusal by the patient
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215007


Contacts
Contact: Igor Wolfgang Blau, Dr. 0049 30 8445 4430 igor.blau@charite.de
Contact: Martin Schmidt-Hieber, Dr. 0049 30 8445 4555 martin.schmidt-hieber@charite.de

Locations
Germany
Charite, CBF Recruiting
Berlin, Germany, 12200
Contact: Igor Wolfgang Blau         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Chair: Igor Wolfgang Blau, Dr. Charite, CBF, Berlin, Germany
More Information

ClinicalTrials.gov Identifier: NCT00215007     History of Changes
Other Study ID Numbers: Levosta-CBF-02/04
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 30, 2007
Last Verified: February 2004

Additional relevant MeSH terms:
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors