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Completed

NCT Number: NCT00643409

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

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.

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Key information

Conditions

Maxillary Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.

Exclusion criteria

Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.

Treatment and study plan

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

Drug

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

Placebo

Other

placebo

Levofloxacin

Drug

levofloxacin 500 mg capsule by mouth qd x 10 days

Primary outcomes

  1. sponsor assessment of clinical response for the Clinical per Protocol population

    Time frame: Test of Cure (TOC) visit (Day 17-24)

Secondary outcomes

  1. sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population

    Time frame: EOT visit and TOC visit

  2. investigator assessment of clinical response for the Clinical per Protocol population

    Time frame: TOC visit

  3. bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population

    Time frame: TOC visit

  4. summary of baseline susceptibilities

    Time frame: Study endpoint

  5. adverse events

    Time frame: Continuous

  6. laboratory abnormalities

    Time frame: during and post-treatment

  7. sponsor assessment of clinical response for the Clinical per Protocol population

    Time frame: End of Treatment (EOT) visit (Day 11-13)

  8. sponsor assessment of clinical response for the remaining study populations

    Time frame: EOT visit and TOC visit

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration

Important dates

Study start
2003
Study completion
2004
First posted
Mar 26, 2008
Registry last updated
May 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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