Skip to main content
OpenTrials
Completed

NCT Number: NCT01032174

Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or nor pregnant or lactating female outpatients, 18 years of age or older.
  • A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 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:

i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice

  • A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:
  • complete or partial opacification
  • an air/fluid level

Two or more of the following:

  • fever, as defined by temperature: >38ºC
  • leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;
  • headache,
  • nasal congestion and post nasal drainage.

Exclusion criteria

  • Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.

Treatment and study plan

Azithromycin SR

Drug

Azithromycin SR, 2.0 g by mouth (PO) x 1

Amoxiclav 1000 mg

Drug

Amoxiclav 1000 mg x twice daily, 10 days

Primary outcomes

  1. Percentage of Participants With Response of Very Convenient or Somewhat Convenient

    Time frame: Day 11

    Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.

Secondary outcomes

  1. Percent Compliance With Prescribed Treatment Regimen

    Time frame: Day 11

    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).

  2. Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen

    Time frame: Day 11

    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Acronym: EASY

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2009
Registry last updated
Apr 16, 2012

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.