Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

NCT03850379 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 12124)
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Prophylaxis; Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (1)

• Proportion of Bloodstream Bacterial Infections

  to assess proportion 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

Study Arms (2)

Levo

EXPERIMENTAL

Levofloxacin 500 mg once daily

Drug: Levofloxacin

Cipro

ACTIVE COMPARATOR

Ciprofloxacin 500 mg BID

Drug: Ciprofloxacin

Interventions

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

Levo

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

Cipro

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prolonged QT
• Allergies to ciprofloxacin or levofloxacin

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• Farhan S, Mazur I, Hartzell S, Xie P, Neme K, German A, Mikulandric N, Patel K, Wu M, Kortam N, Yaseen A, Sweidan A, Latack K, Emole J, Peres E, Abidi MH, Ramesh M. Ciprofloxacin versus levofloxacin prophylaxis in hematopoietic stem cell transplantation: A randomized trial. Int J Infect Dis. 2024 Oct;147:107172. doi: 10.1016/j.ijid.2024.107172. Epub 2024 Jul 15.

  PMID: 39019103 RESULT

MeSH Terms

Interventions

Levofloxacin; Ciprofloxacin

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Our study has several limitations that need to be considered when interpreting the results. First, the study was randomized but open-label. This could have influenced decisions about patient care, potentially biasing the results. Second, the study only documented infections until day 60, which might not capture resistant bacterial infections that may occur later. Third, this study unfortunately lacks information on the gut microbiome, which might play a role in the observed outcomes.

Results Point of Contact

• Title: Shatha Farhan
• Organization: Henry Ford Health

sfarhan1@hfhs.org

3137133910

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: March 14, 2018
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Locations

US (1)