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

An observational study of Pneumonia and Lung Abscess, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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). 1. Read more about this study

Who is it for?: Ages 15 to 99 years
Conditions the study is for: Pneumonia, Lung Abscess, Peritonitis
What is being tested?: Sulbactam Sodium/Ampicillin Sodium
Type of treatment: Injection or infusion
How many people: 982 participants
Where: No sites listed yet
Study dates: 12 Mar 2013to 27 Jan 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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. 1. Pneumonia 2. Lung Abscess 3. Peritonitis

Who may be able to join

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. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
Patients aged 15 years or more

Who cannot join

Patients with the following disease who received high doses of UNASYN (less than 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
Patients aged less than 15 years.

About this study

Official title: Special Use-result Surveillance Of Unasyn-s (Kit) For Intravenous Use - A Surveillance On High-dose (>6 G Daily) Administration For Pneumonia, Lung Abscess And Peritonitis -

Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction)
Incidence status of adverse drug reactions
Factors that may affect the safety and effectiveness

Read the detailed description

Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.

Conditions: Pneumonia, Lung Abscess, Peritonitis
Being tested: Sulbactam Sodium/Ampicillin Sodium
Keywords: UNASYN-S, High Dose
Medical subject headings: Pneumonia, Lung Abscess, Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sulbactam Sodium/Ampicillin SodiumDrug
Also called UNASYN-S
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)).

Study groups in NCT01793688
Study group	Role	What they receive
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. Receives: Drug: Sulbactam Sodium/Ampicillin Sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 14 Days

Secondary outcomes (2)

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.
Measured: 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.
Measured: 14 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 201327 Jan 2016

First posted15 Feb 2013 (estimated)
Study start12 Mar 2013
Primary completion27 Jan 2016
Study completion27 Jan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PneumoniaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 982 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01793688
Sponsor's protocol ID: A9231002
Status last verified: Mar 2017
First submitted: 4 Feb 2013
Last updated: 26 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Use-result Surveillance Of Unasyn-s (Kit) For Intravenous Use - A Surveillance On High-dose (>6 G Daily) Administration For Pneumonia, Lung Abscess And Peritonitis -
ClinicalTrials.gov ID: NCT01793688
Acronym / sponsor ID: A9231002
Conditions: Pneumonia, Lung Abscess, Peritonitis
Keywords: UNASYN-S, High Dose
Study type: Observational
Recruitment status: Completed
Enrolment: 982 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 12 Mar 2013 (actual)
Primary completion: 27 Jan 2016 (actual)
Study completion: 27 Jan 2016 (actual)
First posted: 15 Feb 2013 (estimated)
Results: Posted 26 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Adverse Drug Reaction(s) that cannot be expected from precautions (Unexpected Adverse Drug Reaction)
Incidence status of adverse drug reactions
Factors that may affect the safety and effectiveness

Detailed description

Implemented as a Special Investigation by a central registration system. Secondary data collection. Safety and effectiveness of UNASYN-S under Japanese medical practice.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Sulbactam Sodium/Ampicillin Sodium	–	Drug: Sulbactam Sodium/Ampicillin SodiumPatients 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.

Who may qualify

Ages: 15 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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. 1. Pneumonia 2. Lung Abscess 3. Peritonitis

Key inclusion criteria (2 listed)

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. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
Patients aged 15 years or more

Key exclusion criteria (2 listed)

Patients with the following disease who received high doses of UNASYN (less than 6 g per day) from the first dosing date or the second dosing date. 1) Pneumonia, 2) Lung Abscess, 3) Peritonitis
Patients aged less than 15 years.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sulbactam Sodium/Ampicillin SodiumAlso: UNASYN-SIntravenous 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)).	Drug	Sulbactam Sodium/Ampicillin Sodium

Primary outcome

Number of Participants With Treatment-Related Adverse Events
Time frame: 14 Days
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.
Clinical Effectiveness Rate by Indication
Time frame: 14 Days
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.

2 secondary outcomes

Number of Participants With Treatment-Related Serious Adverse Events
Time frame: 14 Days
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Time frame: 14 Days

Results and safety

Results posted to the registry on 26 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sulbactam Sodium/Ampicillin Sodium	982	980

Primary outcome: Number of Participants With Treatment-Related Adverse Events

Time frame: 14 Days. Number. Unit: Participants

Measure	Sulbactam Sodium/Ampicillin Sodium n = 980
Value	96

Population analysed: 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.

Primary outcome: Clinical Effectiveness Rate by Indication

Time frame: 14 Days. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Sulbactam Sodium/Ampicillin Sodium n = 978
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)

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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0.50% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sulbactam Sodium/Ampicillin Sodium	43 of 980 (4.4%)	158 of 980 (16.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumonia and Lung Abscess, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Related Adverse Events (time frame: 14 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01793688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.