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)
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Prophylaxis
• Stem Cell Transplant Complications

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