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Fluoroquinolone Antibiotic

Ciprofloxacin vs Levofloxacin for Stem Cell Transplant Prophylaxis

Phase 2
Waitlist Available
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days post stem cell transplant
Awards & highlights

Study Summary

This trialstudied 2 antibiotics for prophylaxis in stem cell transplants. Results suggest one may be better than the other, but more research is needed.

Who is the study for?
This trial is for adults aged 18-75 who are about to receive a stem cell transplant due to blood cancers and meet the specific program criteria. It's not open to those with allergies to ciprofloxacin or levofloxacin, or individuals with prolonged QT interval, which is an abnormality seen on heart tests.Check my eligibility
What is being tested?
The study compares two antibiotics: Ciprofloxacin and Levofloxacin, used as preventive treatments in patients undergoing stem cell transplants. The goal is to determine which one better prevents infections without causing significant complications.See study design
What are the potential side effects?
Possible side effects of both antibiotics include digestive issues like nausea and diarrhea, potential allergic reactions, nerve damage that can cause pain or weakness, and changes in heartbeat rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old and have been diagnosed with a blood cancer.
Select...
I am eligible for a stem cell transplant according to the program's criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days post stem cell transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days post stem cell transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sepsis

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LevoExperimental Treatment1 Intervention
Levofloxacin 500 mg once daily
Group II: CiproActive Control1 Intervention
Ciprofloxacin 500 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levofloxacin
2011
Completed Phase 4
~8180

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
298 Previous Clinical Trials
2,098,439 Total Patients Enrolled
1 Trials studying Stem Cell Transplant Complications
255 Patients Enrolled for Stem Cell Transplant Complications

Media Library

Ciprofloxacin (Fluoroquinolone Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03850379 — Phase 2
Stem Cell Transplant Complications Research Study Groups: Levo, Cipro
Stem Cell Transplant Complications Clinical Trial 2023: Ciprofloxacin Highlights & Side Effects. Trial Name: NCT03850379 — Phase 2
Ciprofloxacin (Fluoroquinolone Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03850379 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability for volunteers to participate in this experiment?

"According to the clinicaltrials.gov database, this research endeavour has been continuously recruiting since its initial post on March 14th 2018 and was last updated October 24th 2022."

Answered by AI

How many participants are currently receiving treatment in this medical experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical trial is currently enrolling, having first appeared on March 14th 2018 and been updated as recently as October 24th 2022. The study necessitates 308 patients to join from a single site."

Answered by AI

Is participation in this medical study open to new enrollees?

"This research project seeks to recruit 308 patients aged between 18 and 75 that are undergoing prophylaxis. In addition, the following prerequisites must be satisfied: having a hematological malignancy, meeting stem cell transplant program criteria for autologous/allogeneic hematopoietic stem cell transplantation."

Answered by AI

Is this research project extending its recruitment to individuals aged 35 and over?

"This medical trial is open to individuals aged 18 and above, up to a maximum of 75."

Answered by AI

Has the FDA authorized Levofloxacin for public use?

"Given the lack of efficacy data for this Phase 2 trial, our team at Power assigned Levofloxacin a safety rating of 2."

Answered by AI

What applications does Levofloxacin have for medical treatment?

"Levofloxacin is the usual treatment for otitis externa, as well as pyoderma, entercococcus faecalis-caused UTI and abdominal infection."

Answered by AI
~4 spots leftby Apr 2024