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Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT03850379
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Shatha Farhan, 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.

Condition or disease Intervention/treatment Phase
Prophylaxis Stem Cell Transplant Complications Drug: Levofloxacin Drug: Ciprofloxacin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Ciprofloxacin Versus Levofloxacin and Rate of Breakthrough Infections in Hematopoietic Stem Cell Transplant Patients
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levo
Levofloxacin 500 mg once daily
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

Active Comparator: Cipro
Ciprofloxacin 500 mg BID
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850379


Contacts
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Contact: shatha farhan, MD 313 713 3910 SFARHAN1@HFHS.ORG
Contact: Nlaini Janakiraman 313 916 5002

Locations
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United States, Michigan
Henry Ford Recruiting
Detroit, Michigan, United States, 48202
Contact: shatha farhan         
Sponsors and Collaborators
Henry Ford Health System

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Responsible Party: Shatha Farhan, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03850379     History of Changes
Other Study ID Numbers: 12124)
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Levofloxacin
Ofloxacin
Ciprofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors