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The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN).
Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulbactam Sodium/Ampicillin Sodium | Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) by intravenous injection or intravenous drip infusion from the first dosing date or the second dosing date: Pneumonia, Lung Abscess, Peritonitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulbactam Sodium/Ampicillin Sodium | Drug | Intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection or drip infusion. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)). Kit for intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection after dissolved in an accompanying reconstitution diluent. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator. | 14 Days |
| Clinical Effectiveness Rate by Indication | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of participants with assessable effectiveness evaluation, was presented by each indication (pneumonia, lung abcess and peritorinitis) along with the corresponding exact 2-sided 95% confidence interval. Overall effectiveness of sulbactam sodium/ampicillin sodium was determined by the investigator based on clinical symptoms and examinations at the end of high-dose (>6 g daily) treatment. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at the end of treatment. | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Serious Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with the following disease who received high doses of UNASYN (exceeding 6 g per day) from the first dosing date or the second dosing date.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total 986 subjects were registered in this study. Of the 986 subjects, 982 subjects CRFs were collected and included in the study.Of the 982 subjects, 2 subjects were excluded from the safety analysis set (SAS). In total, 980 subjects were included in the SAS as the completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulbactam Sodium/Ampicillin Sodium | The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total 986 subjects were registered in this study. Of the 986 subjects, 982 subjects CRFs were collected and included in the study.Of the 982 participants, 2 participants were excluded from the baseline analysis due to a protocol violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulbactam Sodium/Ampicillin Sodium | The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator. | The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once. | Posted | Number | Participants | 14 Days |
|
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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 | Sulbactam Sodium/Ampicillin Sodium | The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious pleural effusion | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-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 |
|---|---|
| D011014 | Pneumonia |
| D008169 | Lung Abscess |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013407 | Sulbactam |
| D000667 | Ampicillin |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
|
| 14 Days |
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator. | 14 Days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diagnosis | Number | Participants |
|
|
|
| Primary | Clinical Effectiveness Rate by Indication | Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of participants with assessable effectiveness evaluation, was presented by each indication (pneumonia, lung abcess and peritorinitis) along with the corresponding exact 2-sided 95% confidence interval. Overall effectiveness of sulbactam sodium/ampicillin sodium was determined by the investigator based on clinical symptoms and examinations at the end of high-dose (>6 g daily) treatment. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at the end of treatment. | The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once. | Posted | Number | 95% Confidence Interval | Percentage of participants | 14 Days |
|
|
|
| Secondary | Number of Participants With Treatment-Related Serious Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator. | The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once. | Posted | Number | Participants | 14 Days |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator. | The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once. | Posted | Number | Participants | 14 Days |
|
|
|
| 43 |
| 980 |
| 158 |
| 980 |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Tumour invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Adrenal disorder | Endocrine disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Postoperative thrombosis | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 18.1 | Non-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.
| D000038 |
| Abscess |
| D013492 | Suppuration |
| D059413 | Intraabdominal Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010400 | Penicillin G |
|