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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 Committee

The clinical efficacy assessed by Data Review Committee

Secondary outcome:

The clinical efficacy assessed by Data Review Committee

The 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

Page last updated: October 04, 2010

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