Trial Outcomes & Findings for Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration - (NCT NCT01793688)

NCT ID: NCT01793688

Last Updated: 2017-04-26

Results Overview

Recruitment status

COMPLETED

Target enrollment

982 participants

Primary outcome timeframe

14 Days

Results posted on

2017-04-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	982
Overall Study COMPLETED	980
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Protocol Violation	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sulbactam Sodium/Ampicillin Sodium n=980 Participants 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).
Age, Customized >=15 and <65 years	255 Participants n=5 Participants
Age, Customized ˃=65 years	725 Participants n=5 Participants
Sex: Female, Male Female	296 Participants n=5 Participants
Sex: Female, Male Male	684 Participants n=5 Participants
Diagnosis Pneumonia	861 Participants n=5 Participants
Diagnosis Lung Abscess	71 Participants n=5 Participants
Diagnosis Peritonitis	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 Days

Population: 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.

Outcome measures

Outcome measures
Measure	Sulbactam Sodium/Ampicillin Sodium n=980 Participants 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).
Number of Participants With Treatment-Related Adverse Events	96 Participants

PRIMARY outcome

Timeframe: 14 Days

Population: The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once.

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.

Outcome measures

Outcome measures
Measure	Sulbactam Sodium/Ampicillin Sodium n=978 Participants 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).
Clinical Effectiveness Rate by Indication With Pneumonia (n=856)	85.1 Percentage of participants Interval 82.4 to 87.5
Clinical Effectiveness Rate by Indication With Lung Abcess (n=70)	78.5 Percentage of participants Interval 66.5 to 87.7
Clinical Effectiveness Rate by Indication With Peritonitis (n=47)	78.7 Percentage of participants Interval 64.3 to 89.3

SECONDARY outcome

Timeframe: 14 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sulbactam Sodium/Ampicillin Sodium n=980 Participants 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).
Number of Participants With Treatment-Related Serious Adverse Events	6 Participants

SECONDARY outcome

Timeframe: 14 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sulbactam Sodium/Ampicillin Sodium n=980 Participants 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).
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	30 Participants

Adverse Events

Sulbactam Sodium/Ampicillin Sodium

Serious events: 43 serious events

Other events: 158 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sulbactam Sodium/Ampicillin Sodium n=980 participants at risk 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).
Infections and infestations Infectious pleural effusion	0.10% 1/980
Infections and infestations Bronchopulmonary aspergillosis	0.10% 1/980
Infections and infestations Varicella	0.10% 1/980
Infections and infestations Septic shock	0.10% 1/980
Infections and infestations Pneumonia	0.20% 2/980
Infections and infestations Lung infection	0.20% 2/980
Infections and infestations Lung abscess	0.20% 2/980
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.10% 1/980
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	0.10% 1/980
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.20% 2/980
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.20% 2/980
Endocrine disorders Adrenal disorder	0.10% 1/980
Metabolism and nutrition disorders Marasmus	0.10% 1/980
Metabolism and nutrition disorders Malnutrition	0.10% 1/980
Metabolism and nutrition disorders Dehydration	0.10% 1/980
Metabolism and nutrition disorders Hypokalaemia	0.10% 1/980
Metabolism and nutrition disorders Hypocalcaemia	0.10% 1/980
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.10% 1/980
Nervous system disorders Cerebral infarction	0.10% 1/980
Nervous system disorders Hemiplegia	0.10% 1/980
Cardiac disorders Atrial fibrillation	0.10% 1/980
Vascular disorders Hypotension	0.10% 1/980
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.10% 1/980
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.51% 5/980
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.10% 1/980
Respiratory, thoracic and mediastinal disorders Asphyxia	0.20% 2/980
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.31% 3/980
Gastrointestinal disorders Gastric ulcer	0.10% 1/980
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.10% 1/980
Gastrointestinal disorders Pancreatitis	0.10% 1/980
Hepatobiliary disorders Cholecystitis	0.10% 1/980
Skin and subcutaneous tissue disorders Rash	0.10% 1/980
Renal and urinary disorders Acute kidney injury	0.10% 1/980
Renal and urinary disorders Renal impairment	0.10% 1/980
General disorders Disease progression	0.20% 2/980
General disorders Multi-organ failure	0.10% 1/980
Investigations White blood cell count increased	0.10% 1/980
Injury, poisoning and procedural complications Postoperative thrombosis	0.10% 1/980
Metabolism and nutrition disorders Hyperkalaemia	0.10% 1/980

Other adverse events

Other adverse events
Measure	Sulbactam Sodium/Ampicillin Sodium n=980 participants at risk 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).
Metabolism and nutrition disorders Decreased appetite	0.92% 9/980
Blood and lymphatic system disorders Anaemia	0.82% 8/980
Investigations Aspartate aminotransferase increased	0.82% 8/980
General disorders Pyrexia	0.71% 7/980
Psychiatric disorders Restlessness	0.61% 6/980
Psychiatric disorders Delirium	0.61% 6/980
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.61% 6/980
Hepatobiliary disorders Liver disorder	0.61% 6/980
Investigations Alanine aminotransferase increased	0.61% 6/980
Gastrointestinal disorders Diarrhoea	2.3% 23/980
Respiratory, thoracic and mediastinal disorders Cough	1.4% 14/980
Metabolism and nutrition disorders Hypokalaemia	1.2% 12/980
Psychiatric disorders Insomnia	1.1% 11/980
Hepatobiliary disorders Hepatic function abnormal	1.1% 11/980
Gastrointestinal disorders Constipation	1.0% 10/980
Metabolism and nutrition disorders Hypoalbuminaemia	0.51% 5/980
Skin and subcutaneous tissue disorders Rash	0.51% 5/980
Investigations Protein total decreased	0.51% 5/980

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER