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

University of Cologne

Status and phase: Completed; Phase 3

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

Treatments: Drug: placebo; Drug: moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00398411

2005-003271-21 (EudraCT Number)

05001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

Moxifloxacin

Experimental group

Description:

moxifloxacin 400 mg tablets once daily

Treatment:

Drug: moxifloxacin

Placebo

Placebo Comparator group

Description:

identical appearing placebo

Treatment:

Drug: placebo