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ampicillin/sulbactam

Phase 3

Pneumonia, Bacterial | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Jul 13, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

ampicillin/sulbactam · 1 trial · 1 indication

Phase 3 1
NCT01189487The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)Pneumonia, Bacterial
COMPLETED47 Analytics
PHASE3COMPLETED
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Pneumonia, Bacterial
NCT0118948747
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Study Endpoints

Primary Endpoints

Response Rate (Clinical Response, Data Review Committee Assessment)
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.

Secondary Endpoints

Response Rate (Clinical Response, Investigator Assessment)
End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
The Tendency Toward Clinical Improvement (Investigator Assessment)
Day 4
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ampicillin sodium/sulbactam sodiumEXPERIMENTALampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV

Interventions

NameTypeDescription
ampicillin sodium/sulbactam sodiumDRUGampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
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Eligibility Criteria

Age Range16 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites22

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 sodiu...

Countries:Japan
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