Ciprofloxacin Versus Levofloxacin and Rate of Breakthrough Infections in Hematopoietic Stem Cell Transplant Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 308
- Locations
- 1
- Primary Endpoint
- Proportion of Bloodstream Bacterial Infections
Study Overview
Brief Summary
Ciprofloxacin and levofloxacin are both in guidelines to use for prophylaxis in autologous and allogeneic Stem cell transplant.Ciprofloxacin was recently replaced by levofloxacin as the preferred agent in some transplant centers. In some small retrospective studies ciprofloxacin prophylaxis was associated with a higher rate of breakthrough gram positive bloodstream infections. However, the optimum oral agent for antibacterial prophylaxis in transplant recipients remains uncertain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients 18-75 years of age with a diagnosis of a hematological malignancy. Meet the stem cell transplant program criteria to undergo autologous or allogeneic hematopoietic stem cell transplantation.
Exclusion Criteria
- •Prolonged QT
- •Allergies to ciprofloxacin or levofloxacin
Arms & Interventions
Levo
Levofloxacin 500 mg once daily
Intervention: Levofloxacin (Drug)
Cipro
Ciprofloxacin 500 mg BID
Intervention: Ciprofloxacin (Drug)
Outcomes
Primary Outcomes
Proportion of Bloodstream Bacterial Infections
Time Frame: 60 days post stem cell transplant
to assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant
Secondary Outcomes
No secondary outcomes reported
Investigators
Shatha Farhan
Principal Investigator
Henry Ford Health System