Pelvic Inflammatory Disease
Conditions
Brief summary
Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.
Interventions
DRUGAzithromycin
The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Both of following symptoms should be observed. * Lower abdominal pain and/or lower abdominal tenderness. * Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).
Exclusion criteria
Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides. Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | 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 inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | 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 inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy. |
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | End of treatment, Day 15, Day 29 | Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy. |
| Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | End of treatment, Day 15, Day 29 | Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Azithromycin Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy) | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 5 |
Baseline characteristics
| Characteristic | Azithromycin |
|---|---|
| Age Continuous | 32.2 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 76 |
| serious Total, serious adverse events | 3 / 76 |
Outcome results
Primary
Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
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 inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Time frame: End of Treatment, Day 15 and Day 29
Population: Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | End of Treatment (n=51) | 94.1 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 15 (n=51) | 94.1 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 29 (n=46) | 93.5 percentage of participants |
Secondary
Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Eradication Rate was calculated from the following formula, the number of participants assessed as eradication, presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Time frame: End of treatment, Day 15, Day 29
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 Categories was the total participants EXCLUDING ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | End of treatment (n=31) | 77.4 percentage of participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 15 (n=34) | 85.3 percentage of participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 29 (n=31) | 83.9 percentage of participants |
Secondary
Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Eradication Rate was calculated from the following formula, the number of participants assessed as eradication , presumed eradication and microbial substitution over total participants excluding ones assessed as indeterminate multiplied by 100. The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Time frame: End of treatment, Day 15, Day 29
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 Categories was the total participants EXCLUDING ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | End of treatment (n=14) | 85.7 percentageof participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 15 (n=11) | 85.7 percentageof participants |
| Azithromycin | Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 29 (n=19) | 89.5 percentageof participants |
Secondary
Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
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 inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Time frame: End of Treatment, Day 15 and Day 29
Population: Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Categories means total participants excluding ones assessed as indeterminate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Azithromycin | Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | End of Treatment (n=51) | 92.2 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 15 (n=48) | 100 percentage of participants |
| Azithromycin | Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Day 29 (n=46) | 100 percentage of participants |