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
• 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

• Lung Abscess
• Peritonitis
• Pneumonia

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

External Links

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