Clinical trial NCT01189487: The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Bacterial
Keywords: ampicillin sodium/sulbactam sodium
Unasyn-S
community acquired pneumonia
bacterial pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 \[Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin \> 3 times upper limit of normal range values\].
* Severe renal dysfunction (creatinine clearance \< 30 ml/min).
* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.

Primary outcomes:
measure: Response Rate (Clinical Response, Data Review Committee Assessment)
timeFrame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Secondary outcomes:
measure: Response Rate (Clinical Response, Investigator Assessment)
timeFrame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
measure: The Tendency Toward Clinical Improvement (Investigator Assessment)
timeFrame: Day 4
measure: Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
timeFrame: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
measure: Eradication Rate (Bacteriological Response, Investigator Assessment)
timeFrame: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Other outcomes:
Locations:
city: Seto-shi
country: Japan
facility: Tosei General Hospital
state: Aichi-ken
city: Kitakyushu
country: Japan
facility: National Hospital Organization Kokura Medical Center
state: Fukuoka
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health
state: Fukuoka
city: Yanagawa
country: Japan
facility: Nagata Hospital
state: Fukuoka
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Sapporo
country: Japan
facility: National Hokkaido Medical Center
state: Hokkaido
city: Himejishi
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Takamatsu
country: Japan
facility: KKR Takamatsu Hospital
state: Kagawa
city: Kawasaki-city
country: Japan
facility: Nippon Koukan Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Koushi-shi
country: Japan
facility: National Hospital Organization Kumamoto Saishyunsou Hospital
state: Kumamoto
city: Shiogama
country: Japan
facility: Saka General Hospital/Respiratory
state: Miyagi
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital
state: Nagano
city: Isahaya
country: Japan
facility: Japanese Red Cross Nagasaki Genbaku Isahaya Hospital
state: Nagasaki
city: Nagasaki-city
country: Japan
facility: Nagasaki University School of Medicine
state: Nagasaki
city: Tsukubo-gun
country: Japan
facility: National Hospital Organization Minami-Okayama Medical Center
state: Okayama
city: Ureshino-shi
country: Japan
facility: National Hospital Organization Ureshino Medical Center
state: Saga
city: Sayama
country: Japan
facility: Sekishinkai Sayama Hospital
state: Saitama
city: Hamamatsu
country: Japan
facility: National Hospital Organization Tenryu National Hospital
state: Shizuoka
city: Fukuoka
country: Japan
facility: Fukuoka Sanno Hospital
city: Kochi
country: Japan
facility: National Hospital Organization Kochi National Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kohno S, Tateda K, Mikamo H, Kadota J, Niki Y, Itamura R. Efficacy and safety of intravenous sulbactam/ampicillin 3 g 4 times daily in Japanese adults with moderate to severe community-acquired pneumonia: a multicenter, open-label, uncontrolled study. J Infect Chemother. 2015 Mar;21(3):182-8. doi: 10.1016/j.jiac.2014.11.006. Epub 2014 Nov 20.
citation: Soto E, Shoji S, Muto C, Tomono Y, Marshall S. Population pharmacokinetics of ampicillin and sulbactam in patients with community-acquired pneumonia: evaluation of the impact of renal impairment. Br J Clin Pharmacol. 2014 Mar;77(3):509-21. doi: 10.1111/bcp.12232.