Moxifloxacin Prophylaxis: Moxifloxacin in the Prevention of Bacteremia After High-Dose Chemotherapy and Transplantation of Peripheral Stem Cells - Full Text View

Sponsor:	University of Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00398411

Purpose

This study investigates whether the prophylactic use of moxifloxacin during high-dose chemotherapy followed by autologous stem cell transplantation reduces the incidence of clinically significant bacteremia.

Further investigations include time to occurrence of fever, duration of fever, overall survival and antibiotic sensitivity of blood isolates.

Condition	Intervention	Phase
Hodgkin Disease Non-Hodgkin Lymphoma Multiple Myeloma Bacteremia	Drug: moxifloxacin Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Double-Blind, Prospective, Randomized, Mono-Center, Placebo-Controlled Pilot Study to Investigate the Efficacy and Safety of Moxifloxacin in the Prevention of Bacteremia After High-Dose Chemotherapy and Transplantation of Peripheral Stem Cells

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Fever Hodgkin Disease Lymphoma Multiple Myeloma

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:

incidence of clinically significant bacteremia [ Time Frame: during treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

type of isolates and infections [ Time Frame: at end of treatment ] [ Designated as safety issue: No ]
time to occurrence of fever [ Time Frame: during treatment ] [ Designated as safety issue: No ]
days of fever [ Time Frame: follow up ] [ Designated as safety issue: No ]
overall survival [ Time Frame: follow up 28 days after stem cell transplantation ] [ Designated as safety issue: Yes ]

Enrollment:	68
Study Start Date:	October 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

400 mg p.o. per day

one tablet per day p.o.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

High-dose chemotherapy followed by peripheral autologous stem cell transplantation
Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid tumor

Exclusion Criteria:

Allogenic stem cell transplantation
Aplastic anemia
Antibiotic treatment within seven days prior to randomization
Signs and symptoms of current infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398411

Locations

Germany
Klinikum der Universität zu Köln
Köln, Germany, 50924

Sponsors and Collaborators

University of Cologne

Investigators

Principal Investigator:

Oliver A. Cornely, MD

Universität zu Köln

More Information

No publications provided

Responsible Party:	Prof. Dr. med. Oliver Cornely, University Hospital of Cologne
ClinicalTrials.gov Identifier:	NCT00398411 History of Changes
Other Study ID Numbers:	05001, EudraCT-No. 2005-003271-21
Study First Received:	November 8, 2006
Last Updated:	March 11, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:

prophylaxis
bacteremia
moxifloxacin
stem cell transplantation
Hodgkin disease

non-Hodgkin lymphoma
multiple myeloma
solid tumor
autologous stem cell transplantation

Additional relevant MeSH terms:

Bacteremia
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012