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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2004 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00215007
First received: September 15, 2005
Last updated: November 29, 2007
Last verified: February 2004
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00215007     History of Changes
Other Study ID Numbers: Levosta-CBF-02/04
Study First Received: September 15, 2005
Last Updated: November 29, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Neoplasms
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on June 18, 2013