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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Notify MeKey information
Conditions
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
Amoxicillin/clavulanate
DrugPrimary outcomes
-
Patient reported symptom resolution at day 5
Secondary outcomes
-
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.
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