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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: moxifloxacin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin<br>moxifloxacin 400 mg tablets once daily | Drug: moxifloxacin<br>* 400 mg p.o. per day<br>* Other names: Avalox;|
| Placebo Comparator: Placebo<br>identical appearing placebo | Drug: placebo<br>* one tablet per day p.o.<br>* Other names: placebo preparation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Absolute neutrophil count (ANC) recovered to > 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever >= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prophylaxis, bacteremia, moxifloxacin, stem cell transplantation, Hodgkin disease, non-Hodgkin lymphoma, multiple myeloma, solid tumor, autologous stem cell transplantation