Trial · NCT01793688
Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -
NCT01793688, Completed, Pfizer; results first posted 2017-04-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -. Trials, record NCT01793688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01793688
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -
- NCT number
- NCT01793688
- Status
- Completed
- Enrollment
- 982 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumonia, Lung Abscess, Peritonitis
- Interventions
- Sulbactam Sodium/Ampicillin Sodium
- First posted
- 2013-02-15
- Last updated
- 2017-04-26
- Results first posted
- 2017-04-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Related Adverse Events | 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. |
| Primary | Clinical Effectiveness Rate by Indication | 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. |
| Secondary | Number of Participants With Treatment-Related Serious Adverse Events | 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. 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. |
| Secondary | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 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. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Related Adverse Events | 14 Days | 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. | Participants | NUMBER |
| PRIMARY | Clinical Effectiveness Rate by Indication | 14 Days | The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Serious Adverse Events | 14 Days | 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 14 Days | 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. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | Sulbactam Sodium/Ampicillin Sodium | 96 | Participants | ||
| Clinical Effectiveness Rate by Indication | Sulbactam Sodium/Ampicillin Sodium | With Pneumonia (n=856) | 85.1 | 95% Confidence Interval 82.4 to 87.5 | Percentage of participants |
| Clinical Effectiveness Rate by Indication | Sulbactam Sodium/Ampicillin Sodium | With Lung Abcess (n=70) | 78.5 | 95% Confidence Interval 66.5 to 87.7 | Percentage of participants |
| Clinical Effectiveness Rate by Indication | Sulbactam Sodium/Ampicillin Sodium | With Peritonitis (n=47) | 78.7 | 95% Confidence Interval 64.3 to 89.3 | Percentage of participants |
| Number of Participants With Treatment-Related Serious Adverse Events | Sulbactam Sodium/Ampicillin Sodium | 6 | Participants | ||
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | Sulbactam Sodium/Ampicillin Sodium | 30 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sulbactam Sodium/Ampicillin Sodium | 982 | |
| Overall Study | COMPLETED | Sulbactam Sodium/Ampicillin Sodium | 980 | |
| Overall Study | NOT COMPLETED | Sulbactam Sodium/Ampicillin Sodium | 2 |
Source ClinicalTrials.gov
Adverse events57
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased appetite | Metabolism and nutrition disorders | Sulbactam Sodium/Ampicillin Sodium | 9 | 980 | |
| other | Anaemia | Blood and lymphatic system disorders | Sulbactam Sodium/Ampicillin Sodium | 8 | 980 | |
| other | Aspartate aminotransferase increased | Investigations | Sulbactam Sodium/Ampicillin Sodium | 8 | 980 | |
| other | Pyrexia | General disorders | Sulbactam Sodium/Ampicillin Sodium | 7 | 980 | |
| other | Restlessness | Psychiatric disorders | Sulbactam Sodium/Ampicillin Sodium | 6 | 980 | |
| other | Delirium | Psychiatric disorders | Sulbactam Sodium/Ampicillin Sodium | 6 | 980 | |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Sulbactam Sodium/Ampicillin Sodium | 6 | 980 | |
| other | Liver disorder | Hepatobiliary disorders | Sulbactam Sodium/Ampicillin Sodium | 6 | 980 | |
| other | Alanine aminotransferase increased | Investigations | Sulbactam Sodium/Ampicillin Sodium | 6 | 980 | |
| other | Diarrhoea | Gastrointestinal disorders | Sulbactam Sodium/Ampicillin Sodium | 23 | 980 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sulbactam Sodium/Ampicillin Sodium | ||
| Total, other adverse events | Sulbactam Sodium/Ampicillin Sodium | 158 | 980 |
| Total, serious adverse events | Sulbactam Sodium/Ampicillin Sodium | 43 | 980 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01793688
GET https://conductscience.org/api/trials/v1/NCT01793688/events?page=2