Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant
Phase 2
Active, not recruiting
- Conditions
- ProphylaxisStem Cell Transplant Complications
- Interventions
- Registration Number
- NCT03850379
- Lead Sponsor
- Henry Ford Health System
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 308
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levo Levofloxacin Levofloxacin 500 mg once daily Cipro Ciprofloxacin Ciprofloxacin 500 mg BID
- Primary Outcome Measures
Name Time Method incidence of bloodstream bacterial infections 60 days post stem cell transplant to assess incidence of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Henry Ford
🇺🇸Detroit, Michigan, United States