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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | Azithromycin switch therapy (switch from intravenous to oral) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of Treatment, Day 15 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | End of Treatment, Day 15 and Day 29 |
| The Tendency Toward Clinical Improvement (Investigator Assessment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Seto-shi | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24477328 | Derived | Kohno S, Tateda K, Kadota J, Fujita J, Niki Y, Watanabe A, Nagashima M. Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia. J Infect Chemother. 2014 Mar;20(3):199-207. doi: 10.1016/j.jiac.2013.10.010. Epub 2013 Dec 11. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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. |
| Day 3 |
| 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 | Day 3, End of Treatment, Day 15 and Day 29 |
| 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 | Day 3, End of Treatment, Day 15 and Day 29 |
| Touon |
| Ehime |
| Japan |
| Pfizer Investigational Site | Chikushino-shi | Fukuoka | Japan |
| Pfizer Investigational Site | Fukuoka | Fukuoka | Japan |
| Pfizer Investigational Site | Koga | Fukuoka | Japan |
| Pfizer Investigational Site | Yanagawa | Fukuoka | Japan |
| Pfizer Investigational Site | Higashihiroshima | Hiroshima | Japan |
| Pfizer Investigational Site | Hiroshima | Hiroshima | Japan |
| Pfizer Investigational Site | Asahikawa | Hokkaido | Japan |
| Pfizer Investigational Site | Himejishi | Hyōgo | Japan |
| Pfizer Investigational Site | Moriya | Ibaraki | Japan |
| Pfizer Investigational Site | Kanazawa | Ishikawa-ken | Japan |
| Pfizer Investigational Site | Takamatsu | Kagawa-ken | Japan |
| Pfizer Investigational Site | Kawasaki | Kanagawa | Japan |
| Pfizer Investigational Site | Kochi | Kochi | Japan |
| Pfizer Investigational Site | Tsu | Mie-ken | Japan |
| Pfizer Investigational Site | Sendai | Miyagi | Japan |
| Pfizer Investigational Site | Matsumoto | Nagano | Japan |
| Pfizer Investigational Site | Emukae, Kitamatsuura | Nagasaki | Japan |
| Pfizer Investigational Site | Isahaya | Nagasaki | Japan |
| Pfizer Investigational Site | Nagasaki | Nagasaki | Japan |
| Pfizer Investigational Site | Sasebo | Nagasaki | Japan |
| Pfizer Investigational Site | Niigata | Niigata | Japan |
| Pfizer Investigational Site | Ōita | Oita Prefecture | Japan |
| Pfizer Investigational Site | Yufu | Oita Prefecture | Japan |
| Pfizer Investigational Site | Kurashiki | Okayama-ken | Japan |
| Pfizer Investigational Site | Okinawa | Okinawa | Japan |
| Pfizer Investigational Site | Sakai | Osaka | Japan |
| Pfizer Investigational Site | Ureshinoshi | Saga-ken | Japan |
| Pfizer Investigational Site | Hamamatsu | Shizuoka | Japan |
| Pfizer Investigational Site | Meguro-Ku | Tokyo | Japan |
| Pfizer Investigational Site | Toshima-ku | Tokyo | Japan |
| Pfizer Investigational Site | Yonezawa | Yamagata | Japan |
| Pfizer Investigational Site | Shiogama | Japan |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Treatment, Day 15 and Day 29 |
|
|
| ||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Treatment, Day 15 and Day 29 |
|
| |||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | participants | Day 3 |
|
| ||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 3, End of Treatment, Day 15 and Day 29 |
|
| |||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | 95% Confidence Interval | percentageof participants | Day 3, End of Treatment, Day 15 and Day 29 |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 8 | 102 | 33 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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