Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia

NCT01032694 | Terminated Results

• 1 other identifier: A0661200
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare compliance between patients with CAP 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 CAP in outpatient clinic practice.

Conditions

Community-Acquired Pneumonia

Keywords

Community-Acquired Pneumonia; Azithromycin SR; Amoxiclav

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'.

  Days 11-12

Secondary Outcomes (2)

• Percent Compliance With the Prescribed Treatment Regimen

  Days 11-12

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

  Days 11-12

Study Arms (2)

Z-max treated group

Patients with Community-Acquired Pneumonia

Drug: Azithromycin SR

Amoxiclav treated group

Patients with Community-Acquired Pneumonia

Drug: Amoxiclav

Interventions

Azithromycin SR DRUG

Azithromycin SR, 2.0 g PO x 1 dose for treatment period

Z-max treated group

Amoxiclav DRUG

Amoxiclav 1000 x twice daily, 10 days duration

Amoxiclav treated group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Community-Acquired Pneumonia.

You may qualify if:

• Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:
• Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
• Body temperature \>38 degrees C.

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

Community-Acquired Pneumonia

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

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 CONTROL
• 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: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 21, 2011
• Results First Posted: December 21, 2011

Record last verified: 2011-11