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NCT01793688 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT01793688
Other study ID # A9231002
Secondary ID
Status Completed
Phase N/A
First received February 4, 2013
Last updated December 7, 2015
Start date March 2013
Est. completion date September 2015

Study information
Verified date December 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

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

Description:

Implemented as a Special Investigation by a central registration system

Recruitment information / eligibility
Status Completed
Enrollment 986
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 99 Years
Eligibility Inclusion Criteria:

- Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis

- Patients aged 15 years or olde

Exclusion Criteria:

- Patients with the following disease who received high doses of UNASYN (less than 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis

- Patients aged less than 15 years.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Sulbactam Sodium (SBT)/Ampicillin Sodium (ABPC)
Intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection or drip infusion. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)). Kit for intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection after dissolved in an accompanying reconstitution diluent. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Clinical Benefit 14 days No
Secondary C-Reactive Protein (CRP) 14 days No
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