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ampicillin/sulbactam

Phase 4

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

ampicillin/sulbactam development status

Highest phase Phase 4 (NCT00137007)
Phase scored for PFEPhase 3
Registered trials 1 across 1 sponsor since Aug 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

ampicillin/sulbactam clinical trials

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, BacterialUnlock trial analytics

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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Frequently asked questions about ampicillin/sulbactam

What is ampicillin/sulbactam used for?

Ampicillin/sulbactam is an antibiotic combination being studied for the treatment of bacterial pneumonia. It pairs ampicillin, a penicillin-class antibiotic, with sulbactam, which helps preserve ampicillin's activity against certain bacteria. It is being developed by Pfizer, Inc. (ticker: PFE) and is in Phase 3 clinical development.

Who makes ampicillin/sulbactam?

Ampicillin/sulbactam is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development program for this antibiotic combination.

What phase is ampicillin/sulbactam in?

Ampicillin/sulbactam is in Phase 3 clinical development. It is an investigational product and is not approved based on the information available. The Phase 3 trial has been completed, and no active trials are currently listed.

What clinical trials is ampicillin/sulbactam in?

Ampicillin/sulbactam has been evaluated in one completed Phase 3 trial, NCT01189487, titled "The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)." The trial enrolled 47 participants in Japan, included patients aged 16 years and older of all sexes, and was uncontrolled.