Clinical trial NCT00398411: Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
Official title: Double-blind, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2006-11-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of Clinically Significant Bacteremia
timeFrame: 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:
measure: Type of Isolates and Infections
timeFrame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
measure: Time to Occurrence of Fever >= 38°C
timeFrame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
measure: Reason for Discontinuation of Treatment
timeFrame: end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
measure: Type of Infection
timeFrame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
measure: Overall Survival
timeFrame: follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Klinikum der Universität zu Köln
Study officials:
affiliation: Universität zu Köln
name: Oliver A. Cornely, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.