The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Bacterial
Intervention: ampicillin sodium/sulbactam sodium (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
Unasyn-S 12g/day (3g,QID) 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 (3g, q. i.d. ) IV.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The clinical efficacy assessed by Data Review CommitteeThe clinical efficacy assessed by Data Review Committee
Secondary outcome: The clinical efficacy assessed by Data Review CommitteeThe clinical efficacy assessed by Data Review Committee The clinical efficacy assessed by Investigator The clinical efficacy assessed by Investigator The clinical efficacy assessed by Investigator The tendency toward clinical improvement assessed by Investigator The bacteriological efficacy assessed by Data Review Committee The bacteriological efficacy assessed by Data Review Committee The bacteriological efficacy assessed by Data Review Committee The bacteriological efficacy assessed by Data Review Committee The bacteriological efficacy assessed by Investigator The bacteriological efficacy assessed by Investigator The bacteriological efficacy assessed by Investigator The bacteriological efficacy assessed by Investigator Safety; AEs, laboratory test values and vital sign PPK analysis
Eligibility
Minimum age: 16 Years.
Maximum age: 79 Years.
Gender(s): Both.
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 (AST, 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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Nagata Hospital, Yanagawa, Fukuoka, Japan
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2010
Last updated: October 4, 2010
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