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

Last updated on April 10, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia, Lung Abscess, Peritonitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01793688
Pfizer
Completed
Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration ‐

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Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration ?
Special Use-result Surveillance Of Unasyn-s (Kit) For Intravenous Use - A Surveillance On High-dose (>6 G Daily) Administration For Pneumonia, Lung Abscess And Peritonitis ?

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
Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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
  • Pneumonia
  • Lung Abscess
  • Peritonitis
Drug: 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)).

Other Name: UNASYN-S
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.
Intervention: Drug: Sulbactam Sodium/Ampicillin Sodium
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
982
January 27, 2016
January 27, 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
15 Years to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01793688
A9231002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

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