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

First Received on September 15, 2005. Last Updated on November 29, 2007 History of Changes

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00215007

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 II Phase III

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:

MedlinePlus related topics: Bacterial Infections Cancer

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

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 February 09, 2012