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Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ampicillin sodium/sulbactam sodium | Experimental | ampicillin sodium/sulbactam sodium 12g/day (3 g four times a day) IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ampicillin sodium/sulbactam sodium | Drug | ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days |
|
| 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, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
| 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, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
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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 |
|---|---|---|---|---|---|---|
| Tosei General Hospital | Seto-shi | Aichi-ken | Japan | |||
| Fukuoka Sanno Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25533886 | Derived | Kohno S, Tateda K, Mikamo H, Kadota J, Niki Y, Itamura R. Efficacy and safety of intravenous sulbactam/ampicillin 3 g 4 times daily in Japanese adults with moderate to severe community-acquired pneumonia: a multicenter, open-label, uncontrolled study. J Infect Chemother. 2015 Mar;21(3):182-8. doi: 10.1016/j.jiac.2014.11.006. Epub 2014 Nov 20. | |
| 24102758 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ampicillin Sodium/Sulbactam Sodium | Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ampicillin Sodium/Sulbactam Sodium | Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. "n" in the Measure Values means total participants EXCLUDING ones assessed as indeterminate. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
|
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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 | Ampicillin Sodium/Sulbactam Sodium | Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D018410 | Pneumonia, Bacterial |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D013407 | Sulbactam |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
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|
| 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 4 and was determined to continue the treatment. | Day 4 |
| 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. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
| 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. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
| Fukuoka |
| Fukuoka |
| Japan |
| National Hospital Organization Kokura Medical Center | Kitakyushu | Fukuoka | Japan |
| University of Occupational and Environmental Health | Kitakyushu | Fukuoka | Japan |
| Nagata Hospital | Yanagawa | Fukuoka | Japan |
| National Hospital Organization Asahikawa Medical Center | Asahikawa | Hokkaido | Japan |
| National Hokkaido Medical Center | Sapporo | Hokkaido | Japan |
| National Hospital Organization Himeji Medical Center | Himejishi | Hyōgo | Japan |
| KKR Takamatsu Hospital | Takamatsu | Kagawa-ken | Japan |
| Nippon Koukan Hospital | Kawasaki | Kanagawa | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Yokohama | Kanagawa | Japan |
| National Hospital Organization Kochi National Hospital | Kochi | Kochi | Japan |
| National Hospital Organization Kumamoto Saishyunsou Hospital | Koushi-shi | Kumamoto | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Kumamoto | Japan |
| Saka General Hospital/Respiratory | Shiogama | Miyagi | Japan |
| National Hospital Organization Matsumoto Medical Center Chushin Matsumoto Hospital | Matsumoto | Nagano | Japan |
| Japanese Red Cross Nagasaki Genbaku Isahaya Hospital | Isahaya | Nagasaki | Japan |
| Nagasaki University School of Medicine | Nagasaki | Nagasaki | Japan |
| National Hospital Organization Minami-Okayama Medical Center | Tsukubo-gun | Okayama-ken | Japan |
| National Hospital Organization Ureshino Medical Center | Ureshino-shi | Saga-ken | Japan |
| Sekishinkai Sayama Hospital | Sayama | Saitama | Japan |
| National Hospital Organization Tenryu National Hospital | Hamamatsu | Shizuoka | Japan |
| Soto E, Shoji S, Muto C, Tomono Y, Marshall S. Population pharmacokinetics of ampicillin and sulbactam in patients with community-acquired pneumonia: evaluation of the impact of renal impairment. Br J Clin Pharmacol. 2014 Mar;77(3):509-21. doi: 10.1111/bcp.12232. |
| years |
|
| Sex: Female, Male | Count of Participants | 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. | Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. "n" in the Measure Values means total participants excluding ones assessed as indeterminate. | Posted | Number | 95% Confidence Interval | percentage of participants | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
|
|
|
| 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 4 and was determined to continue the treatment. | Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. | Posted | Number | percentage of participants | Day 4 |
|
|
|
| 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. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. | 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 Values was the total participants EXCLUDING ones assessed as indeterminate. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
|
|
|
| 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. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. | 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 Values was the total participants EXCLUDING ones assessed as indeterminate. | Posted | Number | 95% Confidence Interval | percentageof participants | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) |
|
|
|
| 1 |
| 47 |
| 19 |
| 47 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | 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.
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017714 | Community-Acquired Infections |
| Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|
| Title | Measurements |
|---|---|
|
| Long term follow up (n=21) |
|
| Title | Measurements |
|---|---|
|
| Long term follow up (n=19) |
|