Community Acquired Pneumonia (CAP)
Conditions
Brief summary
Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
Interventions
DRUGAzithromycin
The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 16 years of age or older patients with CAP. * Patients who were diagnosed as moderate in severity.
Exclusion criteria
* Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides. * Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal). * Severe renal dysfunction (creatinine clearance \< 30 ml/min). * Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation. * Severe underlying disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (Clinical Response, Data Review Committee Assessment) | End of Treatment, Day 15 and Day 29 | 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, Day 15 and Day 29 | 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 3 | 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 3, and was determined to continue the treatment. |
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 3, End of Treatment, Day 15 and Day 29 | 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 |
| Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 3, End of Treatment, Day 15 and Day 29 | 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azithromycin Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy) | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lack of Efficacy | 18 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Azithromycin |
|---|---|
| Age Continuous | 55.4 years STANDARD_DEVIATION 18.6 |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 102 |
| serious Total, serious adverse events | 8 / 102 |
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, Day 15 and Day 29
Population: Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the measured values means total participants excluding ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Response Rate (Clinical Response, Data Review Committee Assessment) | End of Treatment (n=73) | 86.3 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Data Review Committee Assessment) | Day 15 (Primary analysis ) (n=71) | 84.5 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Data Review Committee Assessment) | Day 29 (n=70) | 82.9 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
Time frame: Day 3, End of Treatment, Day 15 and Day 29
Population: Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the measured values was the total participants EXCLUDING ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 3 (n=28) | 71.4 percentage of participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | End of Treatment (n=31) | 80.6 percentage of participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 15 (n=30) | 83.3 percentage of participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 29 (n=30) | 83.3 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
Time frame: Day 3, End of Treatment, Day 15 and Day 29
Population: Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the measured values was the total participants EXCLUDING ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 3 (n=27) | 74.1 percentageof participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Investigator Assessment) | End of Treatment (n=29) | 86.2 percentageof participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 15 (n=25) | 100.0 percentageof participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 29 (n=25) | 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, Day 15 and Day 29
Population: Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the measured values means total participants excluding ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Response Rate (Clinical Response, Investigator Assessment) | End of Treatment (n=73) | 80.8 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Investigator Assessment) | Day 15 (n=62) | 98.4 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Investigator Assessment) | Day 29 (n=61) | 95.1 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 3, and was determined to continue the treatment.
Time frame: Day 3
Population: Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, 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) |
|---|---|---|
| Azithromycin | The Tendency Toward Clinical Improvement (Investigator Assessment) | 68 participants |