Levofloxacin for Prophylaxis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Henry Ford, Detroit, MI
Prophylaxis+1 More
Levofloxacin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether ciprofloxacin or levofloxacin is more effective for preventing bacterial infections in individuals who have undergone a stem cell transplant.

See full description

Eligible Conditions

  • Prophylaxis
  • Stem Cell Transplant Complications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prophylaxis

Study Objectives

This trial is evaluating whether Levofloxacin will improve 1 primary outcome in patients with Prophylaxis. Measurement will happen over the course of 60 days post stem cell transplant.

Day 60
incidence of bloodstream bacterial infections

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Prophylaxis

Trial Design

2 Treatment Groups

Cipro
1 of 2
Levo
1 of 2
Active Control
Experimental Treatment

This trial requires 308 total participants across 2 different treatment groups

This trial involves 2 different treatments. Levofloxacin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Levo
Drug
Levofloxacin 500 mg once daily
Cipro
Drug
Ciprofloxacin 500 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levofloxacin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days post stem cell transplant
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 60 days post stem cell transplant for reporting.

Who is running the study

Principal Investigator
S. F.
Shatha Farhan, Principal Investigator
Henry Ford Health System

Closest Location

Henry Ford - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

What are common treatments for prophylaxis?

"The most common intervention for prevention of acute rejection/bacterial infections is prophylactic antibiotic administration, especially in organ transplants. Other common interventions are prophylactic anticoagulant, thrombolytic therapy, and pre-transplant immunosuppressive therapies. A few other common interventions are also identified." - Anonymous Online Contributor

Unverified Answer

What is prophylaxis?

"Prophylaxis is the practice of taking specific precautions to reduce the risk of or delay the onset of disease. This includes not only preventing sickness and disease in the individual, but also preventing the spread or re-infection of specific illnesses in communities or other populations. Those who are vaccinated are considered to have received prophylaxis when vaccines are administered for the purpose of preventing contagious diseases, but can be considered to be 'on prophylaxis' by virtue of having been at risk of such diseases." - Anonymous Online Contributor

Unverified Answer

Can prophylaxis be cured?

"Although no single test has been shown to be able to predict if a preventive strategy will confer a long-term benefit, evidence does support the benefits of screening for, and offering, preventive treatments in order to reduce the incidence of both CVD and osteoporosis." - Anonymous Online Contributor

Unverified Answer

How many people get prophylaxis a year in the United States?

"Only 25% of persons with [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) receive prophylaxis, and it is recommended that everyone with CRC should receive prophylaxis. Given the high number of colorectal cancer cases and high rate of CRC mortality in the United States, prophylaxis is an urgent need to decrease CRC incidence. Additional studies are needed to determine the optimal use of prophylaxis in patients with stage II, III, and IV CRC with no occult rectal cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of prophylaxis?

"There is a tendency for younger men, who have not previously been screened for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), to have fewer symptoms than older men. Older men tend to underestimate their symptom score; thus, younger and healthier men may be more likely to undergo repeat prostate screening." - Anonymous Online Contributor

Unverified Answer

What causes prophylaxis?

"The prevention of venous thromboembolism is a preventive intervention. In terms of secondary prevention, the usefulness of heparin prophylaxis in patients on warfarin has been debated. There is not enough evidence to suggest when or how often aspirin should be used. Low-molecular-weight heparin is used routinely, although evidence to support these conclusions is limited. It has been suggested that, in women with familial risk, routine thromboprophylaxis with low-molecular-weight heparin is warranted once per year." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating prophylaxis?

"We expect that there will be many new medications that will help to treat and hopefully prevent certain types of prophylaxis. Unfortunately, it will be many years before any of these new medications will become widely used treatments and used for prevention." - Anonymous Online Contributor

Unverified Answer

Has levofloxacin proven to be more effective than a placebo?

"We did not find a reduction in exacerbation of exacerbations of COPD, which is a new type of research in COPD. On the contrary, our study suggested levofloxacin to be more effective than a placebo. Levofloxacin is a first-choice antibiotic for the treatment of patients with AECB." - Anonymous Online Contributor

Unverified Answer

Is levofloxacin typically used in combination with any other treatments?

"Patients taking levofloxacin had no significant difference in effectiveness in the treatment of ABVD-responsive or ABVD-resistant CVA in comparison to patients treated with any other second-line or third-line antifungal agent. Patients at increased risk of adverse drug reactions should be closely monitored during the first four weeks of therapy with levofloxacin." - Anonymous Online Contributor

Unverified Answer

How does levofloxacin work?

"Results from a recent paper do support its potential as a good prophylactic agent. Future, larger, randomised-controlled, placebo-controlled and multi-center clinical trials evaluating the prophylactic activity of levofloxacin are warranted." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prophylaxis?

"The use of prophylaxis in both early and late stages of life has been studied several times in the past several years. It has been shown that in patients with schizophrenia, the use of prophylaxis in early stages of life reduces the duration of positive symptoms and can also decrease the risk of relapse after 6 years of prophylaxis.\nAlso in patients with bipolar disorders, the use of anti-depressants prophylaxis has been shown to be effective in reducing symptoms of bipolar depression and relapse rates as well as decreasing suicide rates and improving quality of life." - Anonymous Online Contributor

Unverified Answer

What is levofloxacin?

"There are two main forms of levofloxacin: a standard oral tablet, which is licensed for oral use, and fosfloxacin, which is licensed for intravenous use. The main differences to determine the optimal form of levofloxacin for prophylaxis and treatment of bacterial prostatitis are dose and interval between doses. Oral treatment using levofloxacin is effective for prophylaxis against sepsis and prostate cancer at both dosages, but there is insufficient clinical evidence to determine the optimal dose for treatment of infection." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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