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

Phase 3

Completed

Conditions: Hodgkin Disease
Multiple Myeloma
Non-Hodgkin Lymphoma
Bacteremia

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	identical appearing placebo
Moxifloxacin	moxifloxacin	moxifloxacin 400 mg tablets once daily

Primary Outcome Measures

Name	Time	Method
Incidence of Clinically Significant Bacteremia	end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)
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)	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
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)
Type of Infection	follow up visit (at discharge from hospital up to a maximum of 28 days after transplantation)