Pneumonia, Community-Acquired
Conditions
Brief summary
To evaluate the clinical efficacy and safety in patients with mild or moderate community-acquired pneumonia receiving a dose of 2 g of azithromycin in the SR formulation.
Interventions
DRUGAzithromycin SR
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who were diagnosed as mild or moderate in severity by the classification of pneumonia Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy (established in 2000).
Exclusion criteria
* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases. (Severe assessed by the Severity of underlying diseases and complications of Clinical evaluation methods for new antimicrobial agents to treat respiratory infections (draft) by the Japan Society of Chemotherapy (1997)).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is Data Review Committee's Clinical efficacy at Day 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Data Review Committee's clinical efficacy (at Day 15 and 29) Investigator's clinical efficacy (at Day 8, 15 and 29), and the tendency toward clinical improvement (at Day 4) Bacteriological efficacy (at Day 4, 8, 15 and 29) | — |
| Adverse events and safety Laboratory data | — |
Countries
Japan
Outcome results
None listed