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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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Hodgkin Disease, Non-Hodgkin Lymphoma, Multiple Myeloma, Bacteremia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

incidence of clinically significant bacteremia

Outcome Time Frame:

during treatment

Safety Issue:

No

Principal Investigator

Oliver A. Cornely, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universität zu Köln

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

05001

NCT ID:

NCT00398411

Start Date:

October 2006

Completion Date:

December 2008

Related Keywords:

  • Hodgkin Disease
  • Non-Hodgkin Lymphoma
  • Multiple Myeloma
  • Bacteremia
  • prophylaxis
  • bacteremia
  • moxifloxacin
  • stem cell transplantation
  • Hodgkin disease
  • non-Hodgkin lymphoma
  • multiple myeloma
  • solid tumor
  • autologous stem cell transplantation
  • Bacteremia
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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