Phase 3
N=102
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Community Acquired Pneumonia (CAP)
Bottom Line
View on ClinicalTrials.gov: NCT00809328 ↗Enrolled (actual)
102
Serious AEs
7.8%
Results posted
Apr 2011
Primary outcome: Primary: Response Rate (Clinical Response, Data Review Committee Assessment) — 86.3; 84.5; 82.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Azithromycin (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Clinical Response, Data Review Committee Assessment) |
86.3; 84.5; 82.9 | — |
| SECONDARY Response Rate (Clinical Response, Investigator Assessment) |
80.8; 98.4; 95.1 | — |
| SECONDARY The Tendency Toward Clinical Improvement (Investigator Assessment) |
68 | — |
| SECONDARY Eradication Rate (Bacteriological Response, Data Review Committee Assessment) |
71.4; 80.6; 83.3; 83.3 | — |
| SECONDARY Eradication Rate (Bacteriological Response, Investigator Assessment) |
74.1; 86.2; 100.0; 100.0 | — |
Summary
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
Eligibility Criteria
Inclusion Criteria
- 16 years of age or older patients with CAP.
- Patients who were diagnosed as moderate in severity.
Exclusion Criteria
- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
- Severe renal dysfunction (creatinine clearance < 30 ml/min).
- Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
- Severe underlying disease.
Data sourced from ClinicalTrials.gov (NCT00809328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.