Lung Abscess, Peritonitis, Pneumonia
Conditions
Keywords
UNASYN-S, High Dose
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.
Interventions
DRUGSulbactam 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)).
Sponsors
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | 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. |
| Clinical Effectiveness Rate by Indication | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Serious Adverse Events | 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. |
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 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. |
Participant flow
Pre-assignment details
A total 986 subjects were registered in this study. Of the 986 subjects, 982 subjects CRFs were collected and included in the study.Of the 982 subjects, 2 subjects were excluded from the safety analysis set (SAS). In total, 980 subjects were included in the SAS as the completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Sulbactam Sodium/Ampicillin Sodium The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g \[strength\] daily). | 980 |
| Total | 980 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Sulbactam Sodium/Ampicillin Sodium |
|---|---|
| Age, Customized >=15 and <65 years | 255 Participants |
| Age, Customized ˃=65 years | 725 Participants |
| Diagnosis Lung Abscess | 71 Participants |
| Diagnosis Peritonitis | 48 Participants |
| Diagnosis Pneumonia | 861 Participants |
| Sex: Female, Male Female | 296 Participants |
| Sex: Female, Male Male | 684 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 158 / 980 |
| serious Total, serious adverse events | 43 / 980 |
Outcome results
Primary
Clinical Effectiveness Rate by Indication
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.
Time frame: 14 Days
Population: The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sulbactam Sodium/Ampicillin Sodium | Clinical Effectiveness Rate by Indication | With Pneumonia (n=856) | 85.1 Percentage of participants |
| Sulbactam Sodium/Ampicillin Sodium | Clinical Effectiveness Rate by Indication | With Lung Abcess (n=70) | 78.5 Percentage of participants |
| Sulbactam Sodium/Ampicillin Sodium | Clinical Effectiveness Rate by Indication | With Peritonitis (n=47) | 78.7 Percentage of participants |
Primary
Number of Participants With Treatment-Related Adverse Events
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.
Time frame: 14 Days
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sulbactam Sodium/Ampicillin Sodium | Number of Participants With Treatment-Related Adverse Events | 96 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
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.
Time frame: 14 Days
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sulbactam Sodium/Ampicillin Sodium | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 30 Participants |
Secondary
Number of Participants With Treatment-Related Serious Adverse Events
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.
Time frame: 14 Days
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sulbactam Sodium/Ampicillin Sodium | Number of Participants With Treatment-Related Serious Adverse Events | 6 Participants |