Trial | NCT03160807  Report issue

Title

Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
An Open Label Non Placebo Study to Evaluate Efficacy and Safety of Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    levofloxacin ...

  • Study Participants

    214
Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI
A complicated urinary tract infection is a urinary infection occurring in a patient with a structural or functional abnormality of the genitourinary tract.

Fluoroquinolones have been recommended as the antimicrobials of choice for the empirical treatment of complicated urinary tract. Levofloxacin is a broad spectrum agent, which is known to demonstrate good clinical efficacy against urinary tract infection (UTI).

There is no published evidence available on the empirical use of Levofloxacin 500 mg OD and its optimal duration of therapy in patients with Complicated Urinary Tract Infections (cUTI). The present study evaluates the efficacy and safety, and optimal duration of therapy of levofloxacin 500 mg OD in patients with complicated UTI.
Study Started
Apr 15
2017
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Mar 31
2018
Anticipated
Last Update
May 19
2017

Drug Levofloxacin

Levolet 500 mg OD for 5 days

  • Other names: Levolet 500

Drug Levofloxacin

Levolet 500 OD for 10 days

  • Other names: Levolet 500

Levofloxacin 5 days Experimental

Levolet 500 mg given for 5 days

Levofloxacin 10 days Active Comparator

Levolet 500 mg given for 10 days

Criteria 

Inclusion Criteria:

Men or non-pregnant women over 18 years of age with cUTI in
One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
One or more of the following underlying conditions suggestive of cUTI:
Indwelling urinary catheter.
Neurogenic bladder.
Obstructive uropathy due to lithiasis, tumor or fibrosis.
Acute urinary retention in men

Exclusion Criteria:

History of allergy to quinolones
Are unable to take oral medication
Have an intractable infection requiring > 14 days of therapy
Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
Have prostatitis or epididymitis
Have had a renal transplant
Have ileal loop or vesica- urethral reflux
Have significant liver or kidney impairment
Have a history of tendinopathy associated with fluoroquinolones
Are pregnant, nursing
Have a history of convulsions or CNS disorders
No Results Posted