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

NCT03160807 | Unknown Phase 4

• 1 other identifier: EM_KZ_LEVOLET
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with clinical cure rates at test of cure visit (TOC) defined as follows- Cure: a complete resolution of clinically significant signs & symptoms

  Cure: a complete resolution of clinically significant signs \& symptoms

  Baseline to 5 days

Secondary Outcomes (4)

• Percentage of patients with microbiological eradication at test of cure visit (TOC)

  Baseline to 5 days and upto 10 days

• No. of adverse events in entire study duration

  Baseline to EOT visit (Baseline to 15 days)

• Percentage of patient compliant to therapy in each study arm.

  Baseline to EOT visit (Baseline to 15 days)

• Percentage of patient samples sensitive to levofloxacin in each study arm.

  Baseline to EOT (Baseline to 15 days)

Study Arms (2)

Levofloxacin 5 days

EXPERIMENTAL

Levolet 500 mg given for 5 days

Drug: Levofloxacin

Levofloxacin 10 days

ACTIVE COMPARATOR

Levolet 500 mg given for 10 days

Drug: Levofloxacin

Interventions

Levofloxacin DRUG

Levolet 500 mg OD for 5 days

Also known as: Levolet 500

Levofloxacin 5 days

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street,

Almaty, 050060, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr Ilyas Tungiskhanovich

  Scientific Centre of Urology named after B.U Dzharbusynov 2, Basenov street, Almaty 050060, Republic of Kazakhstan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUHAS S KHANDARKAR

CONTACT

04049002419; suhassk@drreddys.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: May 19, 2017
• Study Start: April 15, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

KA (1)