Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells

NCT00398411 | Completed Phase 3 Results DMC

• 2 other identifiers: 050012005-003271-21
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hodgkin Disease; Non-Hodgkin Lymphoma; Multiple Myeloma; Bacteremia

Keywords

prophylaxis; bacteremia; moxifloxacin; stem cell transplantation; Hodgkin disease; non-Hodgkin lymphoma; multiple myeloma; solid tumor; autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinically Significant Bacteremia

  Failure was defined as clinically significant bacteraemia occurring in the period of neutropenia and an intervention with a systemic antibacterial becoming necessary. With this being a discontinuation criteria and the outcome being measured at end of treatment, only one episode is taken into account for each participant.

  end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)

Secondary Outcomes (5)

• Type of Isolates and Infections

  end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)

• Time to Occurrence of Fever >= 38°C

  end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)

• Reason for Discontinuation of Treatment

  end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)

• Type of Infection

  follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)

• Overall Survival

  follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)

Study Arms (2)

Moxifloxacin

EXPERIMENTAL

moxifloxacin 400 mg tablets once daily

Drug: moxifloxacin

Placebo

PLACEBO COMPARATOR

identical appearing placebo

Drug: placebo

Interventions

moxifloxacin DRUG

400 mg p.o. per day

Also known as: Avalox

Moxifloxacin

placebo DRUG

one tablet per day p.o.

Also known as: placebo preparation

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Klinikum der Universität zu Köln

Cologne, 50924, Germany

Location

Related Publications (1)

• Vehreschild JJ, Moritz G, Vehreschild MJ, Arenz D, Mahne M, Bredenfeld H, Chemnitz J, Klein F, Cremer B, Boll B, Kaul I, Wassmer G, Hallek M, Scheid C, Cornely OA. Efficacy and safety of moxifloxacin as antibacterial prophylaxis for patients receiving autologous haematopoietic stem cell transplantation: a randomised trial. Int J Antimicrob Agents. 2012 Feb;39(2):130-4. doi: 10.1016/j.ijantimicag.2011.10.009. Epub 2011 Dec 12.

  PMID: 22169408 RESULT

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin; Multiple Myeloma; Bacteremia

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Prof. Dr. Oliver A. Cornely
• Organization: University of Cologne

oliver.cornely@zks-koeln.de

+49 221 478 88794

Study Officials

• Oliver A. Cornely, MD

  Universität zu Köln

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the Center of Clinical Trials (ZKS)

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 10, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 29, 2015
• Results First Posted: December 11, 2013

Record last verified: 2015-06

Locations

DE (1)