Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -

Pfizer

Status: Completed

Conditions: Peritonitis; Lung Abscess; Pneumonia

Treatments: Drug: Sulbactam Sodium/Ampicillin Sodium

Study type: Observational

Funder types: Industry

Identifiers

NCT01793688

A9231002

Details and patient eligibility

About

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

Full description

Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.

Enrollment: 982 patients

Sex: All

Ages: 15 to 99 years old

Volunteers: No Healthy Volunteers

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 more

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.

Trial design

982 participants in 1 patient group

Sulbactam Sodium/Ampicillin Sodium

Description:

Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) by intravenous injection or intravenous drip infusion from the first dosing date or the second dosing date: Pneumonia, Lung Abscess, Peritonitis.

Treatment:

Drug: Sulbactam Sodium/Ampicillin Sodium