Breast Cancer Clinical Trial
Official title:
Randomized, Double Blinded, Placebo-Controlled Trial of Antibacterial Prophylaxis for the Prevention of Bacterial Infections in the Post-Engraftment Phase After Allogeneic Hematopoeitic Stem Cell Transplantation
Verified date | May 2017 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 240 |
Est. completion date | December 2012 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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®) |
Country | Name | City | State |
---|---|---|---|
United States | Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute | National Cancer Institute (NCI) |
United States,
Bubalo JS, Leis JF, Curtin PT, et al.: A randomized, double-blinded, pilot trial of aprepitant added to standard antiemetics during conditioning therapy for hematopoietic stem cell transplant (HSCT). [Abstract] J Clin Oncol 25 (Suppl 18): A-9112, 520s, 20
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability | 1 to 120 days post bone marrow transplant | ||
Secondary | Incidence of bacteremia | 1 to 120 days post bone marrow transplant | ||
Secondary | Incidence and severity of graft-versus-host disease | 1 to 120 days post bone marrow transplant | ||
Secondary | Infection-related mortality | 1 to 120 days post bone marrow transplant | ||
Secondary | Overall mortality | 1 to 120 days post bone marrow transplant |
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