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

NCT01032174 | Completed Results

• 1 other identifier: A0661199
• Study Type: observational
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Maxillary Sinusitis

Keywords

Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response of Very Convenient or Somewhat Convenient

  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'.

  Day 11

Secondary Outcomes (2)

• Percent Compliance With Prescribed Treatment Regimen

  Day 11

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

  Day 11

Study Arms (2)

Azithromycin SR

Acute Bacterial Maxillary Sinusitis

Drug: Azithromycin SR

Amoxiclav 1000 mg

Acute Bacterial Maxillary Sinusitis

Drug: Amoxiclav 1000 mg

Interventions

Azithromycin SR DRUG

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

Azithromycin SR

Amoxiclav 1000 mg DRUG

Amoxiclav 1000 mg x twice daily, 10 days

Amoxiclav 1000 mg

Eligibility Criteria

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

Study Population

Patients with Acute Maxillary Sinusitis

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Maxillary Sinusitis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: April 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 16, 2012
• Results First Posted: March 22, 2012

Record last verified: 2012-04