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Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration ‐

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ClinicalTrials.gov Identifier: NCT01793688
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Conditions Pneumonia
Lung Abscess
Peritonitis
Intervention Drug: Sulbactam Sodium/Ampicillin Sodium
Enrollment 982
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Sulbactam Sodium/Ampicillin Sodium
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 982
Completed 980
Not Completed 2
Reason Not Completed
Protocol Violation             2
Arm/Group Title Sulbactam Sodium/Ampicillin Sodium
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 980
Hide Baseline Analysis Population Description
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.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 980 participants
>=15 and <65 years 255
˃=65 years 725
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 980 participants
Female
296
  30.2%
Male
684
  69.8%
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 980 participants
Pneumonia 861
Lung Abscess 71
Peritonitis 48
1.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events
Hide Description 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.
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sulbactam Sodium/Ampicillin Sodium
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 980
Measure Type: Number
Unit of Measure: Participants
96
2.Primary Outcome
Title Clinical Effectiveness Rate by Indication
Hide Description 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.
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once.
Arm/Group Title Sulbactam Sodium/Ampicillin Sodium
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 978
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
With Pneumonia (n=856)
85.1
(82.4 to 87.5)
With Lung Abcess (n=70)
78.5
(66.5 to 87.7)
With Peritonitis (n=47)
78.7
(64.3 to 89.3)
3.Secondary Outcome
Title Number of Participants With Treatment-Related Serious Adverse Events
Hide Description 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.
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sulbactam Sodium/Ampicillin Sodium
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 980
Measure Type: Number
Unit of Measure: Participants
6
4.Secondary Outcome
Title Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Hide Description 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.
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sulbactam Sodium/Ampicillin Sodium
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 980
Measure Type: Number
Unit of Measure: Participants
30
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sulbactam Sodium/Ampicillin Sodium
Hide Arm/Group Description 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).
All-Cause Mortality
Sulbactam Sodium/Ampicillin Sodium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sulbactam Sodium/Ampicillin Sodium
Affected / at Risk (%)
Total   43/980 (4.39%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation * 1  2/980 (0.20%) 
Cardiac disorders   
Atrial fibrillation * 1  1/980 (0.10%) 
Endocrine disorders   
Adrenal disorder * 1  1/980 (0.10%) 
Gastrointestinal disorders   
Gastric ulcer * 1  1/980 (0.10%) 
Upper gastrointestinal haemorrhage * 1  1/980 (0.10%) 
Pancreatitis * 1  1/980 (0.10%) 
General disorders   
Disease progression * 1  2/980 (0.20%) 
Multi-organ failure * 1  1/980 (0.10%) 
Hepatobiliary disorders   
Cholecystitis * 1  1/980 (0.10%) 
Infections and infestations   
Infectious pleural effusion * 1  1/980 (0.10%) 
Bronchopulmonary aspergillosis * 1  1/980 (0.10%) 
Varicella * 1  1/980 (0.10%) 
Septic shock * 1  1/980 (0.10%) 
Pneumonia * 1  2/980 (0.20%) 
Lung infection * 1  2/980 (0.20%) 
Lung abscess * 1  2/980 (0.20%) 
Injury, poisoning and procedural complications   
Postoperative thrombosis * 1  1/980 (0.10%) 
Investigations   
White blood cell count increased * 1  1/980 (0.10%) 
Metabolism and nutrition disorders   
Marasmus * 1  1/980 (0.10%) 
Malnutrition * 1  1/980 (0.10%) 
Dehydration * 1  1/980 (0.10%) 
Hypokalaemia * 1  1/980 (0.10%) 
Hypocalcaemia * 1  1/980 (0.10%) 
Hyperkalaemia * 1  1/980 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer pain * 1  1/980 (0.10%) 
Tumour invasion * 1  1/980 (0.10%) 
Lung neoplasm malignant * 1  2/980 (0.20%) 
Nervous system disorders   
Hypoxic-ischaemic encephalopathy * 1  1/980 (0.10%) 
Cerebral infarction * 1  1/980 (0.10%) 
Hemiplegia * 1  1/980 (0.10%) 
Renal and urinary disorders   
Acute kidney injury * 1  1/980 (0.10%) 
Renal impairment * 1  1/980 (0.10%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  1/980 (0.10%) 
Respiratory failure * 1  5/980 (0.51%) 
Hypercapnia * 1  1/980 (0.10%) 
Asphyxia * 1  2/980 (0.20%) 
Chronic obstructive pulmonary disease * 1  3/980 (0.31%) 
Skin and subcutaneous tissue disorders   
Rash * 1  1/980 (0.10%) 
Vascular disorders   
Hypotension * 1  1/980 (0.10%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.50%
Sulbactam Sodium/Ampicillin Sodium
Affected / at Risk (%)
Total   158/980 (16.12%) 
Blood and lymphatic system disorders   
Anaemia * 1  8/980 (0.82%) 
Gastrointestinal disorders   
Diarrhoea * 1  23/980 (2.35%) 
Constipation * 1  10/980 (1.02%) 
General disorders   
Pyrexia * 1  7/980 (0.71%) 
Hepatobiliary disorders   
Liver disorder * 1  6/980 (0.61%) 
Hepatic function abnormal * 1  11/980 (1.12%) 
Investigations   
Aspartate aminotransferase increased * 1  8/980 (0.82%) 
Alanine aminotransferase increased * 1  6/980 (0.61%) 
Protein total decreased * 1  5/980 (0.51%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  9/980 (0.92%) 
Hypokalaemia * 1  12/980 (1.22%) 
Hypoalbuminaemia * 1  5/980 (0.51%) 
Psychiatric disorders   
Restlessness * 1  6/980 (0.61%) 
Delirium * 1  6/980 (0.61%) 
Insomnia * 1  11/980 (1.12%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  6/980 (0.61%) 
Cough * 1  14/980 (1.43%) 
Skin and subcutaneous tissue disorders   
Rash * 1  5/980 (0.51%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01793688     History of Changes
Other Study ID Numbers: A9231002
First Submitted: February 4, 2013
First Posted: February 15, 2013
Results First Submitted: November 28, 2016
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017