CompletedNot Applicable

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

982 participantsStarted 2013-03-12

Plain-language 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

Who can participate

Age range15 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Treatment-Related Adverse Events

Timeframe: 14 Days

Clinical Effectiveness Rate by Indication

Timeframe: 14 Days

Trial details

NCT IDNCT01793688

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-01-27

Results submitted2016-11-28

View on ClinicalTrials.gov More Pneumonia trials