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NCT03850379 Clinical Trial

Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Stem Cell Transplant Complications Clinical Trial

Official title:
Ciprofloxacin Versus Levofloxacin and Rate of Breakthrough Infections in Hematopoietic Stem Cell Transplant Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03850379
Other study ID # 12124)
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date March 14, 2018
Est. completion date August 30, 2024

Study information
Verified date April 2024
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 308
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
United States Henry Ford Detroit Michigan

Sponsors (1)
Lead Sponsor Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of bloodstream bacterial infections to assess incidence of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant 60 days post stem cell transplant
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