Status:
TERMINATED
Moxifloxacin in Preventing Bacterial Infections in Patients Who Have Undergone Donor Stem Cell Transplant
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Assess the safety and tolerability of giving prophylactic moxifloxacin hydrochloride during the post-engraftment phase in patients who have undergone allogeneic stem cell trans...
Eligibility Criteria
Inclusion
- 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®)
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00324324
Start Date
May 1 2006
End Date
December 1 2012
Last Update
May 9 2017
Active Locations (1)
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1
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098