Phase 3
Completed N=47
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Pneumonia, Bacterial
Source: ClinicalTrials.gov NCT01189487 ↗
Enrolled (actual)
47
Serious AEs
2.1%
Results posted
May 2012
Primary outcomePrimary: Response Rate (Clinical Response, Data Review Committee Assessment) — 97.4; 94.6; 94.4 percentage of participants
Summary
Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Clinical Response, Data Review Committee Assessment) |
97.4; 94.6; 94.4 | — |
| SECONDARY Response Rate (Clinical Response, Investigator Assessment) |
100.0; 100.0; 100.0 | — |
| SECONDARY The Tendency Toward Clinical Improvement (Investigator Assessment) |
100.0 | — |
| SECONDARY Eradication Rate (Bacteriological Response, Data Review Committee Assessment) |
100.0; 96.0; 91.7; 95.2 | — |
| SECONDARY Eradication Rate (Bacteriological Response, Investigator Assessment) |
95.7; 100.0; 95.7; 100.0 | — |
Eligibility Criteria
Inclusion Criteria
- 16 years of age or older.
- Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.
Exclusion Criteria
- Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems.
- Hepatic dysfunction [Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin > 3 times upper limit of normal range values].
- Severe renal dysfunction (creatinine clearance < 30 ml/min).
- Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Data sourced from ClinicalTrials.gov (NCT01189487). 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. Informational only — not medical advice.