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

NCT ID: NCT00398411

Last Updated: 2015-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-12-31

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.

Detailed Description

Because fluoroquinolones have broad antimicrobial coverage, bactericidal activity, high tissue concentrations, oral bioavailability and adequate tolerability and safety profiles, they are ideal candidates as antibacterial prophylaxis in cancer patients. Randomized trials investigating the effect of an antibiotic prophylaxis on patients with intermediate neutropenia have recently been conducted with levofloxacin. The influence of moxifloxacin on the incidence of bacteremia in patients undergoing autologous hematopoetic stem cell transplantation has not been investigated. Moxifloxacin may be another promising alternative, covering a broader spectrum of gram-positive and anaerobic bacteria than first- or secondary generation fluoroquinolones and for instance it is an agent administered only once daily, thus optimizing compliance, a crucial issue in prophylaxis.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Moxifloxacin

moxifloxacin 400 mg tablets once daily

Group Type: EXPERIMENTAL

moxifloxacin

Intervention Type: DRUG

400 mg p.o. per day

Placebo

identical appearing placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

one tablet per day p.o.

Interventions

moxifloxacin

400 mg p.o. per day

Intervention Type: DRUG

placebo

one tablet per day p.o.

Intervention Type: DRUG

Other Intervention Names

Avalox; placebo preparation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Oliver Cornely, MD

Medical Director of the Center of Clinical Trials (ZKS)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver A. Cornely, MD

Role: PRINCIPAL_INVESTIGATOR

Universität zu Köln

Locations

Klinikum der Universität zu Köln

Cologne, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 22169408 (View on PubMed)

Other Identifiers

2005-003271-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

05001

Identifier Type: -

Identifier Source: org_study_id