Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Sponsor

Henry Ford Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT03850379

Collaborator

(none)

308

Enrollment

Location

Arms

53.6

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 14, 2018

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford	Detroit	Michigan	United States	48202

Sponsors and Collaborators

Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shatha Farhan, Principal Investigator, Henry Ford Health System

ClinicalTrials.gov Identifier:

NCT03850379

Other Study ID Numbers:

12124)

First Posted:

Feb 21, 2019

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ciprofloxacin

Levofloxacin

Ofloxacin

Study Results

No Results Posted as of Jul 21, 2022