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 (PROSTO)

Pfizer

Status: Terminated

Conditions: Community-Acquired Pneumonia

Treatments: Drug: Azithromycin SR; Drug: Amoxiclav

Study type: Observational

Funder types: Industry

Identifiers

NCT01032694

A0661200

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  1. Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
  2. Body temperature >38 degrees C.

Exclusion criteria

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

Trial design

30 participants in 2 patient groups

Z-max treated group

Description:

Patients with Community-Acquired Pneumonia

Treatment:

Drug: Azithromycin SR

Amoxiclav treated group

Description:

Patients with Community-Acquired Pneumonia

Treatment:

Drug: Amoxiclav