Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: A donor stem cell transplant can lower the body's immune system, making it difficult to fight off infection. Giving antibiotics, such as moxifloxacin, may help prevent bacterial infections in patients who have recently undergone donor stem cell transplant. It is not yet known whether moxifloxacin is more effective than a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.

PURPOSE: This randomized phase III trial is studying moxifloxacin to see how well it works compared with a placebo in preventing bacterial infections in patients who have recently undergone donor stem cell transplant.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

DISEASE CHARACTERISTICS:

• Must be planning to undergo or have completed allogeneic stem cell transplantation (ASCT)

• Must not be undergoing a nonmyeloablative ASCT

• Must not require antibiotic prophylaxis against bacterial pathogens during the post-engraftment phase as per ASCT protocol

• No known colonization with an antimicrobial-resistant organism normally sensitive to quinolones that is known to increase infection incidence (i.e., ciprofloxacin-resistant Pseudomonas not allowed; vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus aureus allowed)

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 100 days

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Negative pregnancy test

• No known hypersensitivity to fluoroquinolones

• No prolonged QTc interval on EKG (i.e., QTc > 440 milliseconds)

• No uncontrolled hypokalemia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No concurrent class IA (e.g., quinidine or procainamide) or class III (e.g., amiodarone or sotalol) antiarrhythmics

• No concurrent intravenous antibiotics for pre-enrollment infections except vancomycin, linezolid, dalfopristin, or quinupristin (Synercid®)