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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

Last updated on November 18, 2019

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Study Location
Pfizer Investigational Site
Alabaster, Alabama, 35007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Maxillary Sinusitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00643409
Pfizer
Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

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Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Maxillary Sinusitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
    • Other: placebo
  • Experimental: 2
    Interventions:
    • Drug: levofloxacin
    • Other: placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2011)
541
Original Actual Enrollment  ICMJE
 (submitted: March 19, 2008)
504
Actual Study Completion Date  ICMJE February 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Costa Rica,   Czech Republic,   Estonia,   Germany,   India,   Lithuania,   Mexico,   Poland,   Russian Federation,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643409
Other Study ID Numbers  ICMJE A0661078
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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