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

Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

Phase 3
Completed
Conditions
Community-Acquired Infections
Bacterial Pneumonia
Cross Infection
First Posted Date
2004-04-19
Last Posted Date
2013-02-08
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
434
Registration Number
NCT00081575

Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia

Phase 3
Conditions
Fever, Sweats, and Hot Flashes
Infection
Leukemia
Lymphoma
Neutropenia
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2004-03-17
Last Posted Date
2013-12-19
Lead Sponsor
Jonsson Comprehensive Cancer Center
Registration Number
NCT00020865
Locations
🇺🇸

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma

Phase 3
Completed
Conditions
Brain and Central Nervous System Tumors
Breast Cancer
Extragonadal Germ Cell Tumor
Infection
Lung Cancer
Lymphoma
Ovarian Cancer
Small Intestine Cancer
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2003-01-27
Last Posted Date
2013-08-02
Lead Sponsor
Cancer Research Campaign Clinical Trials Centre
Registration Number
NCT00005590
Locations
🇬🇧

University of Birmingham, Birmingham, England, United Kingdom

Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

Phase 4
Completed
Conditions
Community-Acquired Pneumonia (CAP)
Interventions
First Posted Date
2002-05-06
Last Posted Date
2017-03-10
Lead Sponsor
Pfizer
Target Recruit Count
219
Registration Number
NCT00035347
Locations
🇪🇸

Pfizer Investigational Site, Tarrasa, Cataluna, Spain

A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting

Phase 3
Completed
Conditions
Pneumonia
First Posted Date
2002-05-03
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
691
Registration Number
NCT00034736

A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.

Not Applicable
Completed
Conditions
HIV Infections
Tuberculosis
First Posted Date
2001-08-31
Last Posted Date
2021-11-03
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
525
Registration Number
NCT00000796
Locations
🇺🇸

Montefiore Drug Treatment Ctr / Bronx Municipal Hosp, Bronx, New York, United States

🇺🇸

Cook County Hosp, Chicago, Illinois, United States

🇺🇸

Bronx Lebanon Hosp Ctr, Bronx, New York, United States

and more 18 locations

The Treatment of Tuberculosis in HIV-Infected Patients

Phase 3
Completed
Conditions
HIV Infections
Tuberculosis
First Posted Date
2001-08-31
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
650
Registration Number
NCT00001033
Locations
🇺🇸

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States

🇺🇸

Univ. of Miami AIDS CRS, Miami, Florida, United States

🇺🇸

Cook County Hosp. CORE Ctr., Chicago, Illinois, United States

and more 9 locations

A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin

Phase 1
Completed
Conditions
HIV Infections
Tuberculosis
First Posted Date
2001-08-31
Last Posted Date
2008-08-08
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
44
Registration Number
NCT00000778
Locations
🇺🇸

Tulane Univ Med School, New Orleans, Louisiana, United States

🇺🇸

UCLA Med Ctr, Los Angeles, California, United States

🇺🇸

Harbor - UCLA Med Ctr, Torrance, California, United States

and more 7 locations

A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

Phase 1
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
R W Johnson Pharmaceutical Research Institute
Registration Number
NCT00002249
Locations
🇺🇸

R W Johnson Pharmaceutical Research Institute, Raritan, New Jersey, United States

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