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Drug Use Investigation Of Sulbactam/Ampicillin (UNASYN) 12g (Regulatory Post Marketing Commitment Plan)

Last updated on March 30, 2020

FOR MORE INFORMATION
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 olde

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
Drug Use Investigation Of Sulbactam/Ampicillin (UNASYN) 12g (Regulatory Post Marketing Commitment Plan)

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Descriptive Information
Brief Title Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration ?
Official Title 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 ?
Brief 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
Detailed Description Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

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
Condition
  • Pneumonia
  • Lung Abscess
  • Peritonitis
Intervention 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
Study Groups/Cohorts 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
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 15, 2017)
982
Original Estimated Enrollment
 (submitted: February 14, 2013)
1000
Actual Study Completion Date January 27, 2016
Actual Primary Completion Date January 27, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01793688
Other Study ID Numbers A9231002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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