MedPath

Levofloxacin

Generic Name
Levofloxacin
Brand Names
Levaquin, Quinsair
Drug Type
Small Molecule
Chemical Formula
C18H20FN3O4
CAS Number
100986-85-4
Unique Ingredient Identifier
RIX4E89Y14
Background

Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic ofloxacin. It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer). Levofloxacin, along with other quinolones such as gatifloxacin and moxifloxacin, is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections.

Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.

Indication

In oral and intravenous formulations, levofloxacin is indicated in adults for the treatment of various infections caused by susceptible bacteria, including infections of the upper respiratory tract, lower respiratory tract, skin, skin structures, urinary tract, and prostate. The oral formulation is also indicated in both adults and children 6 months of age and older for the post-exposure management of inhalational anthrax caused by Bacillus anthracis and for the treatment and/or prophylaxis of plague caused by Yersinia pestis.

In its ophthalmic formulation, levofloxacin is indicated for the treatment of bacterial conjunctivitis caused by susceptible organisms. An inhalational solution available in Canada is indicated for the management of cystic fibrosis patients aged 18 years or older with chronic pulmonary Pseudomonas aeruginosa infections.

Associated Conditions
Abscesses caused by susceptible bacteria, Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible bacteria, Acute Pyelonephritis caused by Infection Due to Escherichia Coli, Bacterial Conjunctivitis caused by susceptible bacteria, Cellulitis caused by susceptible bacteria, Community Acquired Pneumonia (CAP) caused by susceptible bacteria, Furuncle caused by susceptible bacteria, Impetigo caused by susceptible bacteria, Inhalational Anthrax, Nosocomial Pneumonia caused by Pseudomonas Infections, Nosocomial Pneumonia caused by susceptible bacteria, Plague caused by Yersinia pestis, Pyoderma caused by susceptible bacteria, Wound Infections caused by susceptible bacteria, Acute bacterial sinusitis caused by susceptible bacteria, Chronic Bacterial prostatitis caused by susceptible bacteria, Chronic Pseudomonas Infections, Complicated Urinary Tract Infection caused by susceptible bacteria, Complicated skin and skin-structure infections caused by susceptible bacteria, Uncomplicated Urinary Tract Infection caused by susceptible bacteria, Uncomplicated skin and skin-structure infections caused by susceptible bacteria

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

Phase 3
Completed
Conditions
Acute Leukemias of Ambiguous Lineage
Bacterial Infection
Diarrhea
Fungal Infection
Musculoskeletal Complications
Neutropenia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Interventions
First Posted Date
2011-06-13
Last Posted Date
2020-12-07
Lead Sponsor
Children's Oncology Group
Target Recruit Count
624
Registration Number
NCT01371656
Locations
🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Loma Linda University Medical Center, Loma Linda, California, United States

🇺🇸

Michigan State University - Breslin Cancer Center, Lansing, Michigan, United States

and more 81 locations

Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study

Phase 4
Completed
Conditions
Disease Due to BK Polyomavirus
Kidney Transplant Infection
Interventions
First Posted Date
2011-05-13
Last Posted Date
2024-04-05
Lead Sponsor
Ottawa Hospital Research Institute
Target Recruit Count
154
Registration Number
NCT01353339
Locations
🇨🇦

Capital Health - University of Alberta Hospital, Edmonton, Alberta, Canada

🇨🇦

Winnipeg Health Science Center, Winnipeg, Manitoba, Canada

🇨🇦

Vancouver General Hospital, Vancouver, British Columbia, Canada

and more 8 locations

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

Phase 3
Completed
Conditions
Pyelonephritis
Complicated Urinary Tract Infection
Interventions
First Posted Date
2011-05-02
Last Posted Date
2018-10-25
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
558
Registration Number
NCT01345929

Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Phase 2
Completed
Conditions
Community-Acquired Bacterial Pneumonia
Interventions
First Posted Date
2010-07-23
Last Posted Date
2017-03-03
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
132
Registration Number
NCT01168713

Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Phase 3
Completed
Conditions
Helicobacter Pylori Infection
First Posted Date
2010-05-26
Last Posted Date
2011-08-09
Lead Sponsor
Deva Holding A.S.
Target Recruit Count
60
Registration Number
NCT01131026
Locations
🇹🇷

Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology, Kayseri, Turkey

Pharmacokinetic Evaluation of Fluoroquinolone Antibiotics Administered Intravenously in Intensive Care Patients With Normal Renal Function and With Renal Hyperfiltration

Phase 3
Completed
Conditions
Infection
Interventions
First Posted Date
2010-04-23
Last Posted Date
2021-06-29
Lead Sponsor
University Ghent
Target Recruit Count
14
Registration Number
NCT01109823
Locations
🇧🇪

University Ghent, Ghent, Belgium

🇧🇪

University Hospital Ghent, Ghent, Belgium

A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)

Phase 2
Completed
Conditions
Complicated Urinary Tract Infection
Acute Pyelonephritis
Interventions
First Posted Date
2010-03-31
Last Posted Date
2018-08-22
Lead Sponsor
Achaogen, Inc.
Target Recruit Count
145
Registration Number
NCT01096849

Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

Phase 2
Terminated
Conditions
Community Acquired Pneumonia
Interventions
First Posted Date
2010-03-05
Last Posted Date
2012-05-07
Lead Sponsor
IASO Pharma Inc.
Target Recruit Count
48
Registration Number
NCT01081964

BK Treatment Study

Phase 4
Completed
Conditions
BK Viremia
Interventions
Drug: placebo
First Posted Date
2009-12-17
Last Posted Date
2017-04-24
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
43
Registration Number
NCT01034176
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Lahey Clinic Medical Center, Burlington, Massachusetts, United States

and more 5 locations

LEVOS - Levofloxacin and Rifampicin Therapy in the Treatment of OsteoArticular Prothethic Infection

Phase 3
Terminated
Conditions
Infection
Interventions
First Posted Date
2009-05-21
Last Posted Date
2011-02-07
Lead Sponsor
Sanofi
Target Recruit Count
10
Registration Number
NCT00906048
Locations
🇫🇷

Sanofi-Aventis Administrative Office, Paris, France

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