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NCT00215007 Clinical Trial

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

Malignancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00215007
Other study ID # Levosta-CBF-02/04
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received September 15, 2005
Last updated November 29, 2007

Study information
Verified date February 2004
Source Charite University, Berlin, Germany
Contact Igor Wolfgang Blau, Dr.
Phone 0049 30 8445 4430
Email igor.blau@charite.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Allogeneic SCT

- Postneutropenic period

- Written consent

Exclusion Criteria:

- Fever

- Antibiotic therapy

- Neutropenia

- Refusal by the patient

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Levofloxacin

Locations
Country Name City State
Germany Charite, CBF Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

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