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Drug Use Investigation Of Sulbactam/Ampicillin (UNASYN) 12g (Regulatory Post Marketing Commitment Plan)

Pneumonia Clinical Trial

Official title:
Drug Use Investigation Of Sulbactam/Ampicillin 12g

Clinical Trial Summary

The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN).

1. Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction)

2. Incidence status of adverse drug reactions

3. Factors that may affect the safety and effectiveness

Clinical Trial Description

Implemented as a Special Investigation by a central registration system ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01793688
Study type Observational
Source Pfizer
Contact
Status Completed
Phase N/A
Start date March 2013
Completion date September 2015
View Details
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