Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Study is planned to evaluate safety and efficacy of Levolet in patients with complicated UTI

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Levofloxacin; Ofloxacin

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