Pneumonia, Bacterial
Conditions
Keywords
ampicillin sodium/sulbactam sodium, Unasyn-S, community acquired pneumonia, bacterial pneumonia
Brief summary
Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
Interventions
DRUGampicillin sodium/sulbactam sodium
ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 16 years of age or older. * Patients who were diagnosed as moderate to severe community acquired pneumonia requiring initial intravenous therapy and hospitalization.
Exclusion criteria
* Known or suspected hypersensitivity or intolerance to ampicillin sodium/sulbactam sodium, other penicillins, or cephems. * Hepatic dysfunction \[Aspartate Aminotransferase(AST), Alanine Aminotransferase (ALT), total bilirubin \> 3 times upper limit of normal range values\]. * Severe renal dysfunction (creatinine clearance \< 30 ml/min). * Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (Clinical Response, Data Review Committee Assessment) | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (Clinical Response, Investigator Assessment) | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Response rate was calculated from the following formula, the number of participants assessed as effective over total participants EXCLUDING ones assessed as indeterminate multiplied by 100. |
| The Tendency Toward Clinical Improvement (Investigator Assessment) | Day 4 | The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment. |
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. |
| Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ampicillin Sodium/Sulbactam Sodium Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | Ampicillin Sodium/Sulbactam Sodium |
|---|---|
| Age Continuous | 62.3 years STANDARD_DEVIATION 16.4 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 47 |
| serious Total, serious adverse events | 1 / 47 |
Outcome results
Primary
Response Rate (Clinical Response, Data Review Committee Assessment)
Response rate was calculated from the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100.
Time frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Population: Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants EXCLUDING ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ampicillin Sodium/Sulbactam Sodium | Response Rate (Clinical Response, Data Review Committee Assessment) | End of treatment (n=39) | 97.4 percentage of participants |
| Ampicillin Sodium/Sulbactam Sodium | Response Rate (Clinical Response, Data Review Committee Assessment) | Test of cure (n=37) | 94.6 percentage of participants |
| Ampicillin Sodium/Sulbactam Sodium | Response Rate (Clinical Response, Data Review Committee Assessment) | Long term follow up (n=36) | 94.4 percentage of participants |
Secondary
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment.
Time frame: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Population: Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Test of cure (n=24) | 91.7 percentage of participants |
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 4 (n=24) | 100.0 percentage of participants |
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | End of treatment (n=25) | 96.0 percentage of participants |
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Long term follow up (n=21) | 95.2 percentage of participants |
Secondary
Eradication Rate (Bacteriological Response, Investigator Assessment)
Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication or microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment.
Time frame: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Population: Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 4 (n=23) | 95.7 percentageof participants |
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Investigator Assessment) | End of treatment (n=24) | 100.0 percentageof participants |
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Investigator Assessment) | Test of cure (n=23) | 95.7 percentageof participants |
| Ampicillin Sodium/Sulbactam Sodium | Eradication Rate (Bacteriological Response, Investigator Assessment) | Long term follow up (n=19) | 100.0 percentageof participants |
Secondary
Response Rate (Clinical Response, Investigator Assessment)
Response rate was calculated from the following formula, the number of participants assessed as effective over total participants EXCLUDING ones assessed as indeterminate multiplied by 100.
Time frame: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Population: Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants excluding ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ampicillin Sodium/Sulbactam Sodium | Response Rate (Clinical Response, Investigator Assessment) | End of treatment (n=40) | 100.0 percentage of participants |
| Ampicillin Sodium/Sulbactam Sodium | Response Rate (Clinical Response, Investigator Assessment) | Test of cure (n=38) | 100.0 percentage of participants |
| Ampicillin Sodium/Sulbactam Sodium | Response Rate (Clinical Response, Investigator Assessment) | Long term follow up (n=34) | 100.0 percentage of participants |
Secondary
The Tendency Toward Clinical Improvement (Investigator Assessment)
The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment.
Time frame: Day 4
Population: Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ampicillin Sodium/Sulbactam Sodium | The Tendency Toward Clinical Improvement (Investigator Assessment) | 100.0 percentage of participants |