Zmax Compared to Augmentin in Sinusitis

NCT00367120 | Completed Phase 4

• 1 other identifier: A0661180
• Study Type: interventional
• Target: 762
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Patient reported symptom resolution at day 5

Secondary Outcomes (1)

• Time to symptom resolution.

Interventions

Azithromycin Extended Release DRUG

Amoxicillin/Clavulanate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Sinusitis

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 22, 2006
• Study Start: June 1, 2006
• Study Completion: February 1, 2007
• Last Updated: March 16, 2010

Record last verified: 2010-03