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OpenTrials
Completed

NCT Number: NCT00367120

Zmax Compared to Augmentin in Sinusitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

Azithromycin Extended Release

Drug

Amoxicillin/clavulanate

Drug

Primary outcomes

  1. Patient reported symptom resolution at day 5

Secondary outcomes

  1. Time to symptom resolution.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Aug 22, 2006
Registry last updated
Mar 16, 2010

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.

Published trials that share one or more normalized conditions with this study.