The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Unblinded, Non-Comparative Study Of Unasyn-S 12 G/Day Evaluating The Safety And Efficacy In Japanese Adult Subjects With Community Acquired Pneumonia

Conditions
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Pneumonia, Bacterial

Intervention / Treatment
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* Drug: ampicillin sodium/sulbactam sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ampicillin sodium/sulbactam sodium<br>ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV | Drug: ampicillin sodium/sulbactam sodium<br>* ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days<br>* Other names: Unasyn-S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (Clinical Response, Data Review Committee Assessment) | Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100. | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (Clinical Response, Investigator Assessment) | Response rate was calculated from the following formula, the number of participants assessed as effective over total participants EXCLUDING ones assessed as indeterminate multiplied by 100. | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | 
| The Tendency Toward Clinical Improvement (Investigator Assessment) | The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment. | Day 4 | 
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | 
| Eradication Rate (Bacteriological Response, Investigator Assessment) | Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ampicillin sodium/sulbactam sodium, Unasyn-S, community acquired pneumonia, bacterial pneumonia