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OpenTrials
Completed

NCT Number: NCT03850379

Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henry Ford

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin

Drug

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

Drug

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 outcomes

  1. Proportion of Bloodstream Bacterial Infections

    Time frame: 60 days post stem cell transplant

    to assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2019
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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