Zmax Compared to Augmentin in Sinusitis

NCT ID: NCT00367120

Last Updated: 2010-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 762 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2007-02-28

Brief Summary

This study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the study is to compare early resolution of symptoms between the two treatments. Patients will report resolution of their sinusitis symptoms through a daily questionnaire. There will be two follow-up telephone interviews on days 12 and 28 to evaluate quality of life, satisfaction with therapy, and use of healthcare services.

Conditions

Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Azithromycin Extended Release

Intervention Type: DRUG

Amoxicillin/Clavulanate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 days:
• Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
• Presence of one or more of the following signs:
• Discolored (yellow-green) nasal discharge
• Discolored (yellow-green) drainage in the posterior pharynx
• Discolored (yellow-green) discharge from the maxillary sinus orifice
• Two or more of the following symptoms are present:
• Fever, as defined by:
• Oral temperature: >38C or >100.4F, or
• Tympanic temperature: >38.5C or >101.2F
• Frequent coughing
• Nasal congestion,
• Post-nasal drainage.

Exclusion Criteria

• Treatment with any systemic antibiotic within 30 days prior to enrollment
• Symptoms of sinusitis lasting for longer than 30 days;
• Four or more episodes of acute sinusitis within the preceding 12 months;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661180&StudyName=Zmax+Compared+to+Augmentin+in+Sinusitis

To obtain contact information for a study center near you, click here.

Other Identifiers

A0661180

Identifier Type: -

Identifier Source: org_study_id