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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. 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
Information provided by:
Charite University, Berlin, Germany

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

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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

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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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 identifier (NCT number): NCT00215007

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Contact: Igor Wolfgang Blau, Dr. 0049 30 8445 4430
Contact: Martin Schmidt-Hieber, Dr. 0049 30 8445 4555

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Charite, CBF Recruiting
Berlin, Germany, 12200
Contact: Igor Wolfgang Blau         
Sponsors and Collaborators
Charite University, Berlin, Germany
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Study Chair: Igor Wolfgang Blau, Dr. Charite, CBF, Berlin, Germany
Layout table for additonal information Identifier: NCT00215007    
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:
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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