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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

NCT00643409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 541

Last updated 2011-05-11

No results posted yet for this study

Summary

The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.

Conditions

  • Maxillary Sinusitis

Interventions

DRUG

azithromycin SR (Zithromax; compound: CP-62,993)

Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose

OTHER

placebo

placebo

DRUG

levofloxacin

levofloxacin 500 mg capsule by mouth qd x 10 days

OTHER

placebo

placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Completion
2004-02-29

Countries

  • United States
  • Argentina
  • Chile
  • Costa Rica
  • Czechia
  • Estonia
  • Germany
  • India
  • Lithuania
  • Mexico
  • Poland
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643409 on ClinicalTrials.gov