Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT00871494
Status:
COMPLETED
Last Update Posted:
2011-11-03
First Post:
2009-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}], 'ancestors': [{'id': 'D034161', 'term': 'Pelvic Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Azithromycin', 'description': '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)', 'otherNumAtRisk': 76, 'otherNumAffected': 35, 'seriousNumAtRisk': 76, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ovulation pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ovarian haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '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)'}], 'classes': [{'title': 'End of Treatment (n=51)', 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '98.8'}]}]}, {'title': 'Day 15 (n=51)', 'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '98.8'}]}]}, {'title': 'Day 29 (n=46)', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '98.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment, Day 15 and Day 29', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '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)'}], 'classes': [{'title': 'End of Treatment (n=51)', 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '81.1', 'upperLimit': '97.8'}]}]}, {'title': 'Day 15 (n=48)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}]}]}, {'title': 'Day 29 (n=46)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.3', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment, Day 15 and Day 29', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '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)'}], 'classes': [{'title': 'End of treatment (n=31)', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '58.9', 'upperLimit': '90.4'}]}]}, {'title': 'Day 15 (n=34)', 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '95.0'}]}]}, {'title': 'Day 29 (n=31)', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000', 'lowerLimit': '66.3', 'upperLimit': '94.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 15, Day 29', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '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)'}], 'classes': [{'title': 'End of treatment (n=14)', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '57.2', 'upperLimit': '98.2'}]}]}, {'title': 'Day 15 (n=11)', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '63.7', 'upperLimit': '97.0'}]}]}, {'title': 'Day 29 (n=19)', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '98.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 15, Day 29', 'description': '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.\n\nThe 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.', 'unitOfMeasure': 'percentageof participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azithromycin', 'description': '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)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin', 'description': '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)'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.2', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-28', 'studyFirstSubmitDate': '2009-03-27', 'resultsFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2009-03-27', 'lastUpdatePostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-28', 'studyFirstPostDateStruct': {'date': '2009-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'End of Treatment, Day 15 and Day 29', 'description': '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.\n\nThe 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.'}], 'secondaryOutcomes': [{'measure': 'Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)', 'timeFrame': 'End of Treatment, Day 15 and Day 29', 'description': '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.\n\nThe 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.'}, {'measure': '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)', 'timeFrame': 'End of treatment, Day 15, Day 29', 'description': '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.\n\nThe 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.'}, {'measure': 'Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)', 'timeFrame': 'End of treatment, Day 15, Day 29', 'description': '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.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pelvic Inflammatory Disease']}, 'referencesModule': {'references': [{'pmid': '24787738', 'type': 'DERIVED', 'citation': 'Mikamo H, Iwasaku K, Yamagishi Y, Matsumizu M, Nagashima M. Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women. J Infect Chemother. 2014 Jul;20(7):429-35. doi: 10.1016/j.jiac.2014.04.001. Epub 2014 Apr 29.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661192&StudyName=Study%20Of%20Azithromycin%20Intravenous%20Formulation%20Against%20Pelvic%20Inflammatory%20Disease%20%28PID%29%20In%20Japan', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBoth of following symptoms should be observed.\n\n* Lower abdominal pain and/or lower abdominal tenderness.\n* Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).\n\nExclusion Criteria:\n\nKnown or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.\n\nHepatic dysfunction (AST, ALT, total bilirubin \\> 3 times institutional normal).'}, 'identificationModule': {'nctId': 'NCT00871494', 'briefTitle': 'Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Pelvic Inflammatory Disease (PID) Requiring Initial Intravenous Therapy', 'orgStudyIdInfo': {'id': 'A0661192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azithromycin switch therapy (switch from intravenous to oral).', 'interventionNames': ['Drug: Azithromycin']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Azithromycin switch therapy (switch from intravenous to oral).']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi-gun', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Ichinomiya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'city': 'Nagoya-city Naka-ku', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Tanba-gun Fusou-chou', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'city': 'Niihama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.96047, 'lon': 133.30522}}, {'city': 'Kasuga', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52594, 'lon': 130.4611}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kitakyushu-shi, Yahatanishi-ku', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Chuou-ku', 'state': 'Fukuoka-city', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Fukushima', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Takasaki-shi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Hakodate-shi Goryoukaku-cho', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Hakodate-shi Hon-cho', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Chuo-ku', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kounoike Shinmachi', 'state': 'Kagoshima-city', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kamigyou-ku', 'state': 'Kyoto-city', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Nagano', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Suzaka-shi', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Okayama', 'state': 'Okayama-city', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Koshigaya', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'city': 'Aoba-ku', 'state': 'Sendai-city', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Nakaku', 'state': 'Yokohama-city Kanagawa', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.44985, 'lon': 141.22304}}, {'city': 'Fukushima', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}