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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Tosei General Hospital
Seto-shi, Aichi-ken, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Pneumonia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-79 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- Severe underlying disease; patients in which drug clinical evaluation is difficult
because of confounding diseases.

NCT01189487
Pfizer
Completed
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

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The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pneumonia, Bacterial
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
Experimental: ampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV
Intervention: Drug: ampicillin sodium/sulbactam sodium


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
April 2011
April 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 79 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01189487
A9231001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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