Pneumonia
Conditions
Brief summary
The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.
Interventions
DRUGclarithromycin extended release (ER)
7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
DRUGazithromycin SR
Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC \>10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).
Exclusion criteria
Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population | Test of Cure (TOC) visit (Day 14-21) |
Secondary
| Measure | Time frame |
|---|---|
| investigator assessment of clinical response in the Clinical Per Protocol population | TOC visit |
| sponsor assessment of clinical response by baseline pathogen | End of Treatment (EOT) visit (Day 8-11) and TOC visit |
| sponsor assessment of clinical response in the non-primary population | EOT visit and TOC visit |
| sponsor assessment of clinical responses in the Clinical Per Protocol population | EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35) |
| bacteriologic response (eradication rate) in the Bacteriological Per Protocol population | TOC visit |
| adverse events | Continuous |
| vital signs | Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit |
| physical examination | Baseline |
| clinical laboratory assessments (blood chemistry and hematology) | Baseline and TOC visit |
| susceptibilities of baseline pathogens | Study endpoint |
Countries
Argentina, Canada, Estonia, India, Lithuania, Russia, United States
Outcome results
None listed