Zmax Compared to Augmentin in Sinusitis

A Multicenter, Randomized, Open Label Comparative Study Of Azithromycin Extended Release (ZMAX) Versus Amoxicillin/Clavulanate Potassium In Subjects With Acute Bacterial Sinusitis (ABS) In A Physician Practice Environment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367120

Enrollment

762

Registered

2006-08-22

Start date

2006-06-30

Completion date

2007-02-28

Last updated

2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

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.

Interventions

DRUGAzithromycin Extended Release

DRUGAmoxicillin/Clavulanate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
Patient reported symptom resolution at day 5	—

Secondary

Measure	Time frame
Time to symptom resolution.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026