Clinical Trials Logo
  1. Home
  2. Sinusitis
  3. NCT00236522

A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.

Sinusitis Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Levofloxacin 750 mg Once Daily for 5 Days Versus Levofloxacin 500 mg Once Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults.

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of acute bacterial sinusitis (sinus infection) in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given by mouth once daily will be compared to a 10-day course of 500 milligrams of levofloxacin given by mouth once daily.

Clinical Trial Description

When treating sinus infections (sinusitis) caused by bacteria, the traditional duration of therapy is between 10 and 14 days. In this randomized, double-blind study, 5 days of 750 milligrams of levofloxacin given once daily will be compared to 10 days of 500 milligrams of levofloxacin in the treatment of non-hospitalized adult patients who have acute bacterial sinusitis. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study. Patients will have a sinus specimen collected at the first visit. Safety evaluations will be conducted. The objective of the study is to demonstrate that, in the treatment of acute bacterial sinus infections, a 5-day course of 750 milligrams of levofloxacin given once daily is at least as effective as a 10-day course of 500 milligrams of levofloxacin given once daily and is well tolerated.

Patients will take by mouth 750 milligrams levofloxacin capsules once daily for 5 days followed by placebo capsules once daily for 5 days, or 500 milligrams levofloxacin capsules once daily for 10 days. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00236522
Study type Interventional
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status Completed
Phase Phase 3
Start date October 2002
Completion date April 2004
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03584178 - The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis N/A
Completed NCT06016335 - MRI-based Synthetic CT Images of the Head and Neck N/A
Active, not recruiting NCT02278484 - Sinus Balloon Dilation in Pediatric Patients N/A
Withdrawn NCT02071667 - Association of Periostin Levels and Chronic Sinusitis N/A
Completed NCT01420471 - Medicated Punctured-Glove-Finger Spacer Study Phase 4
Completed NCT01118312 - Study of Asthma and Nasal Steroids Phase 4
Completed NCT00645762 - Balloon REmodeling Antrostomy THErapy Study Phase 2
Completed NCT01685229 - Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Active, not recruiting NCT03943121 - The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps N/A
Withdrawn NCT02900794 - Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery N/A
Terminated NCT02630472 - Topical Irrigation Therapy for CRS Phase 1/Phase 2
Completed NCT01442740 - 15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients N/A
Completed NCT01001039 - Validation of the Facial and Cephalic Pain Inventory N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Completed NCT00242437 - Hemostatic Matrix in Endoscopic Sinus Surgery Phase 4
Completed NCT00335309 - Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis N/A
Completed NCT01717274 - Hot Saline Irrigation Study N/A
Completed NCT01166945 - Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children N/A
Completed NCT00747747 - Sinuclean's Treatment Of Sinusitis' Symptoms Phase 4
Not yet recruiting NCT00545961 - Middle Meatal Bacteriology During Acute Respiratory Infection in Children Phase 4