The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
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ClinicalTrials.gov Identifier: NCT01189487 |
Recruitment Status :
Completed
First Posted : August 26, 2010
Results First Posted : May 18, 2012
Last Update Posted : July 13, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumonia, Bacterial | Drug: ampicillin sodium/sulbactam sodium | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
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Drug: ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Other Name: Unasyn-S |
- Response Rate (Clinical Response, Data Review Committee Assessment) [ Time Frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) ]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.
- Response Rate (Clinical Response, Investigator Assessment) [ Time Frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) ]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.
- The Tendency Toward Clinical Improvement (Investigator Assessment) [ Time Frame: Day 4 ]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.
- Eradication Rate (Bacteriological Response, Data Review Committee Assessment) [ Time Frame: 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 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.
- Eradication Rate (Bacteriological Response, Investigator Assessment) [ Time Frame: 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 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.
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Ages Eligible for Study: | 16 Years to 79 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189487
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01189487 |
Other Study ID Numbers: |
A9231001 |
First Posted: | August 26, 2010 Key Record Dates |
Results First Posted: | May 18, 2012 |
Last Update Posted: | July 13, 2012 |
Last Verified: | July 2012 |
ampicillin sodium/sulbactam sodium Unasyn-S community acquired pneumonia bacterial pneumonia |
Pneumonia Pneumonia, Bacterial Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Bacterial Infections Bacterial Infections and Mycoses |
Ampicillin Sulbactam Anti-Bacterial Agents Anti-Infective Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |