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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 66
Healthy volunteers: no

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.

Arms:
arm 1: moxifloxacin 400 mg tablets once daily arm 2: identical appearing placebo

Interventions: intervention 1: moxifloxacin intervention 2: placebo
Intervention descriptions: intervention 1: 400 mg p.o. per day intervention 2: one tablet per day p.o.

Protocol document: