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

September 15, 2005
November 29, 2007
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Complete list of historical versions of study NCT00215007 on ClinicalTrials.gov Archive Site
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Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)
Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With Levofloxacin as Prophylaxis for Bacterial Infections in Immunocompromised Patients After Allogeneic Transplantation of Hematopoietic Stem Cells

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).

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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Malignancy
  • Allogeneic Stem Cell Transplantation
Drug: Levofloxacin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  • Allogeneic SCT
  • Postneutropenic period
  • Written consent

Exclusion Criteria:

  • Fever
  • Antibiotic therapy
  • Neutropenia
  • Refusal by the patient
Both
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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
Germany
 
NCT00215007
Levosta-CBF-02/04
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Charite University, Berlin, Germany
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Study Chair: Igor Wolfgang Blau, Dr. Charite, CBF, Berlin, Germany
Charite University, Berlin, Germany
February 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP