ProphylaxisPhase 2NCT03850379

Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

A Phase 2 study testing Levofloxacin and Ciprofloxacin in people with Prophylaxis and Stem Cell Transplant Complications, run by Henry Ford Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Prophylaxis, Stem Cell Transplant Complications
What is being tested?: Levofloxacin and Ciprofloxacin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 308 participants
Where: 1 siteUnited States
Study dates: 14 Mar 2018to 30 Aug 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Prolonged QT
Allergies to ciprofloxacin or levofloxacin

Trial locations and contacts

1 site in 1 country.

United States1 site

Henry Ford
Detroit, Michigan, 48202

Other trials in United States

About this study

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

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
Being tested: Levofloxacin, Ciprofloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevofloxacinDrug
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
CiprofloxacinDrug
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

Study groups in NCT03850379
Study group	Role	What they receive
Levo	Experimental	Levofloxacin 500 mg once daily Receives: Drug: Levofloxacin
Cipro	Active comparator	Ciprofloxacin 500 mg BID Receives: Drug: Ciprofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 60 days post stem cell transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 201830 Aug 2024

First posted21 Feb 2019
Study start14 Mar 2018
Primary completion30 Aug 2024
Study completion30 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ProphylaxisStudies of the same condition, open and under way.
More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03850379
Sponsor's protocol ID: 12124)
Status last verified: Oct 2025
First submitted: 20 Feb 2019
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 39019103

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ciprofloxacin Versus Levofloxacin and Rate of Breakthrough Infections in Hematopoietic Stem Cell Transplant Patients
ClinicalTrials.gov ID: NCT03850379
Acronym / sponsor ID: 12124)
Conditions: Prophylaxis, Stem Cell Transplant Complications
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 308 participants (actual)
Lead sponsor: Henry Ford Health SystemUniversity, hospital or other
Study start: 14 Mar 2018 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 30 Aug 2024 (actual)
First posted: 21 Feb 2019 (actual)
Results: Posted 20 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Levo	Experimental	Drug: LevofloxacinLevofloxacin 500 mg once daily
Cipro	Active comparator	Drug: CiprofloxacinCiprofloxacin 500 mg BID

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (2 listed)

Prolonged QT
Allergies to ciprofloxacin or levofloxacin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LevofloxacinThis 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	Drug	Levo
CiprofloxacinThis 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	Drug	Cipro

Primary outcome

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

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levo	154	154
Cipro	154	154

Primary outcome: Proportion of Bloodstream Bacterial Infections

Time frame: 60 days post stem cell transplant. Number. Unit: participants

Measure	Levo n = 154	Cipro n = 154
Value	18	18

Adverse events

Time frame: 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levo	23 of 154 (14.9%)	0 of 154 (0%)	42 of 154
Cipro	20 of 154 (13%)	0 of 154 (0%)	54 of 154

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39019103Farhan 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levofloxacin and Ciprofloxacin in people with Prophylaxis and Stem Cell Transplant Complications, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Bloodstream Bacterial Infections (time frame: 60 days post stem cell transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850379, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.