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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

982 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-12

Study Completion Date

2016-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

NCT01189487

Pneumonia, Bacterial

COMPLETED PHASE3

A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization

NCT00797108

Pneumonia, Bacterial

COMPLETED PHASE2

Piperacillin Sodium and Sulbactam Sodium for Injection (2:1) for Treatment of Respiratory and Urinary Tract Infection

NCT01897831

Respiratory Tract Infections Urinary Tract Infections

UNKNOWN PHASE4

Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection

NCT01760109

Respiratory Tract Infections Urinary Tract Infections

COMPLETED PHASE4

Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

NCT02940626

Pneumonia, Ventilator-associated Pneumonia, Staphylococcal

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumonia Lung Abscess Peritonitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sulbactam Sodium/Ampicillin Sodium

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.

Sulbactam Sodium/Ampicillin Sodium

Intervention Type DRUG

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)).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sulbactam Sodium/Ampicillin Sodium

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)).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

UNASYN-S

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No