Trial · NCT00871494
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
NCT00871494, Phase 3, Completed, Pfizer; results first posted 2011-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan. Trials, record NCT00871494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00871494
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
- NCT number
- NCT00871494
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 76 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pelvic Inflammatory Disease
- Interventions
- Azithromycin
- First posted
- 2009-03-30
- Last updated
- 2011-11-03
- Results first posted
- 2011-11-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | 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 | 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. |
| 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) | 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. |
| 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) | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | End of Treatment, Day 15 and Day 29 | 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. | percentage of participants | NUMBER |
| 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) | End of Treatment, Day 15 and Day 29 | 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. | percentage of participants | NUMBER |
| 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) | End of treatment, Day 15, Day 29 | 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. | percentage of participants | NUMBER |
| 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) | End of treatment, Day 15, Day 29 | 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. | percentageof participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Azithromycin | End of Treatment (n=51) | 94.1 | 95% Confidence Interval 83.8 to 98.8 | percentage of participants |
| 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) | Azithromycin | Day 15 (n=51) | 94.1 | 95% Confidence Interval 83.8 to 98.8 | percentage of participants |
| 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) | Azithromycin | Day 29 (n=46) | 93.5 | 95% Confidence Interval 82.1 to 98.6 | percentage of participants |
| Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Azithromycin | End of Treatment (n=51) | 92.2 | 95% Confidence Interval 81.1 to 97.8 | percentage of participants |
| Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Azithromycin | Day 15 (n=48) | 100 | 95% Confidence Interval 92.6 to 100 | percentage of participants |
| Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Azithromycin | Day 29 (n=46) | 100 | 95% Confidence Interval 92.3 to 100 | percentage of participants |
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) | Azithromycin | End of treatment (n=31) | 77.4 | 95% Confidence Interval 58.9 to 90.4 | percentage of participants |
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) | Azithromycin | Day 15 (n=34) | 85.3 | 95% Confidence Interval 68.9 to 95.0 | percentage of participants |
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) | Azithromycin | Day 29 (n=31) | 83.9 | 95% Confidence Interval 66.3 to 94.5 | percentage of participants |
| Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) | Azithromycin | End of treatment (n=14) | 85.7 | 95% Confidence Interval 57.2 to 98.2 | percentageof participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin | 76 | |
| Overall Study | COMPLETED | Azithromycin | 62 | |
| Overall Study | NOT COMPLETED | Azithromycin | 14 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Azithromycin | 2 | 76 | |
| other | Abdominal tenderness | Gastrointestinal disorders | Azithromycin | 3 | 76 | |
| other | Constipation | Gastrointestinal disorders | Azithromycin | 3 | 76 | |
| other | Diarrhoea | Gastrointestinal disorders | Azithromycin | 10 | 76 | |
| other | Gastritis | Gastrointestinal disorders | Azithromycin | 2 | 76 | |
| other | Nausea | Gastrointestinal disorders | Azithromycin | 4 | 76 | |
| other | Injection site pain | General disorders | Azithromycin | 5 | 76 | |
| other | Nasopharyngitis | Infections and infestations | Azithromycin | 4 | 76 | |
| other | Vaginitis bacterial | Infections and infestations | Azithromycin | 2 | 76 | |
| other | Vulvovaginal candidiasis | Infections and infestations | Azithromycin | 2 | 76 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin | ||
| Total, other adverse events | Azithromycin | 35 | 76 |
| Total, serious adverse events | Azithromycin | 3 | 76 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24787738 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00871494
GET https://conductscience.org/api/trials/v1/NCT00871494/events?page=2