Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Overview

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.

Full Title of Study: “Ciprofloxacin Versus Levofloxacin and Rate of Breakthrough Infections in Hematopoietic Stem Cell Transplant Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2024

Interventions

  • Drug: Levofloxacin
    • This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000
  • Drug: Ciprofloxacin
    • This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000

Arms, Groups and Cohorts

  • Experimental: Levo
    • Levofloxacin 500 mg once daily
  • Active Comparator: Cipro
    • Ciprofloxacin 500 mg BID

Clinical Trial Outcome Measures

Primary Measures

  • incidence of bloodstream bacterial infections
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Henry Ford Health System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shatha Farhan, Principal Investigator – Henry Ford Health System

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