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

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ClinicalTrials.gov Identifier: NCT01793688
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Pneumonia Lung Abscess Peritonitis Drug: Sulbactam Sodium/Ampicillin Sodium

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.

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Study Type : Observational
Actual Enrollment : 982 participants
Observational Model: Case-Control
Time Perspective: Prospective
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 ‐
Actual Study Start Date : March 12, 2013
Actual Primary Completion Date : January 27, 2016
Actual Study Completion Date : January 27, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Pneumonia

Group/Cohort Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events [ Time Frame: 14 Days ]
    A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.

  2. Clinical Effectiveness Rate by Indication [ Time Frame: 14 Days ]
    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of participants with assessable effectiveness evaluation, was presented by each indication (pneumonia, lung abcess and peritorinitis) along with the corresponding exact 2-sided 95% confidence interval. Overall effectiveness of sulbactam sodium/ampicillin sodium was determined by the investigator based on clinical symptoms and examinations at the end of high-dose (>6 g daily) treatment. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at the end of treatment.


Secondary Outcome Measures :
  1. Number of Participants With Treatment-Related Serious Adverse Events [ Time Frame: 14 Days ]
    A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.

  2. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: 14 Days ]
    A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.



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Ages Eligible for Study:   15 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793688


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01793688     History of Changes
Other Study ID Numbers: A9231002
First Posted: February 15, 2013    Key Record Dates
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017
Last Verified: March 2017

Keywords provided by Pfizer:
UNASYN-S
High Dose

Additional relevant MeSH terms:
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Ampicillin
Pneumonia
Abscess
Peritonitis
Lung Abscess
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Suppuration
Infection
Inflammation
Pathologic Processes
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Sulbactam
Sultamicillin
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action