Trial · NCT01189487
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
NCT01189487, Phase 3, Completed, Pfizer; results first posted 2012-05-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP). Trials, record NCT01189487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01189487
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
- NCT number
- NCT01189487
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 47 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumonia, Bacterial
- Interventions
- ampicillin sodium/sulbactam sodium
- First posted
- 2010-08-26
- Last updated
- 2012-07-13
- Results first posted
- 2012-05-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (Clinical Response, Data Review Committee Assessment) | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100. |
| Secondary | Response Rate (Clinical Response, Investigator Assessment) | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants EXCLUDING ones assessed as indeterminate" multiplied by 100. |
| Secondary | The Tendency Toward Clinical Improvement (Investigator Assessment) | Day 4 | The number of participants who showed tendency toward clinical improvement based on the assessment of temperature, white blood cell count, C-reactive protein, clinical symptoms on Day 4 and was determined to continue the treatment. |
| Secondary | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication, presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. |
| Secondary | Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication or microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100. Microbial substitution means the appearance of new pathogens other than the original pathogens in a specimen from the same location with signs and symptoms of infection after the original pathogens were eradicated by treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate (Clinical Response, Data Review Committee Assessment) | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants EXCLUDING ones assessed as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Response Rate (Clinical Response, Investigator Assessment) | End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. n in the Measure Values means total participants excluding ones assessed as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | The Tendency Toward Clinical Improvement (Investigator Assessment) | Day 4 | Clinical per protocol set consisted of all participants who received at least one dose, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. | percentage of participants | NUMBER |
| SECONDARY | Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate. | percentage of participants | NUMBER |
| SECONDARY | Eradication Rate (Bacteriological Response, Investigator Assessment) | Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure) | Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. n in the Measure Values was the total participants EXCLUDING ones assessed as indeterminate. | percentageof participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Clinical Response, Data Review Committee Assessment) | Ampicillin Sodium/Sulbactam Sodium | End of treatment (n=39) | 97.4 | 95% Confidence Interval 86.5 to 99.9 | percentage of participants |
| Response Rate (Clinical Response, Data Review Committee Assessment) | Ampicillin Sodium/Sulbactam Sodium | Test of cure (n=37) | 94.6 | 95% Confidence Interval 81.8 to 99.3 | percentage of participants |
| Response Rate (Clinical Response, Data Review Committee Assessment) | Ampicillin Sodium/Sulbactam Sodium | Long term follow up (n=36) | 94.4 | 95% Confidence Interval 81.3 to 99.3 | percentage of participants |
| Response Rate (Clinical Response, Investigator Assessment) | Ampicillin Sodium/Sulbactam Sodium | End of treatment (n=40) | 100.0 | 95% Confidence Interval 91.2 to 100.0 | percentage of participants |
| Response Rate (Clinical Response, Investigator Assessment) | Ampicillin Sodium/Sulbactam Sodium | Test of cure (n=38) | 100.0 | 95% Confidence Interval 90.7 to 100.0 | percentage of participants |
| Response Rate (Clinical Response, Investigator Assessment) | Ampicillin Sodium/Sulbactam Sodium | Long term follow up (n=34) | 100.0 | 95% Confidence Interval 89.7 to 100.0 | percentage of participants |
| The Tendency Toward Clinical Improvement (Investigator Assessment) | Ampicillin Sodium/Sulbactam Sodium | 100.0 | percentage of participants | ||
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Ampicillin Sodium/Sulbactam Sodium | Day 4 (n=24) | 100.0 | 95% Confidence Interval 85.8 to 100.0 | percentage of participants |
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Ampicillin Sodium/Sulbactam Sodium | End of treatment (n=25) | 96.0 | 95% Confidence Interval 79.6 to 99.9 | percentage of participants |
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | Ampicillin Sodium/Sulbactam Sodium | Test of cure (n=24) | 91.7 | 95% Confidence Interval 73.0 to 99.0 | percentage of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ampicillin Sodium/Sulbactam Sodium | 47 | |
| Overall Study | COMPLETED | Ampicillin Sodium/Sulbactam Sodium | 44 | |
| Overall Study | NOT COMPLETED | Ampicillin Sodium/Sulbactam Sodium | 3 |
Source ClinicalTrials.gov
Adverse events12
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 | Constipation | Gastrointestinal disorders | Ampicillin Sodium/Sulbactam Sodium | 5 | 47 | |
| other | Diarrhoea | Gastrointestinal disorders | Ampicillin Sodium/Sulbactam Sodium | 3 | 47 | |
| other | Pyrexia | General disorders | Ampicillin Sodium/Sulbactam Sodium | 2 | 47 | |
| other | Nasopharyngitis | Infections and infestations | Ampicillin Sodium/Sulbactam Sodium | 3 | 47 | |
| other | Alanine aminotransferase increased | Investigations | Ampicillin Sodium/Sulbactam Sodium | 7 | 47 | |
| other | Aspartate aminotransferase increased | Investigations | Ampicillin Sodium/Sulbactam Sodium | 6 | 47 | |
| other | Blood alkaline phosphatase increased | Investigations | Ampicillin Sodium/Sulbactam Sodium | 4 | 47 | |
| other | Gamma-glutamyltransferase increased | Investigations | Ampicillin Sodium/Sulbactam Sodium | 3 | 47 | |
| other | Headache | Nervous system disorders | Ampicillin Sodium/Sulbactam Sodium | 2 | 47 | |
| other | Eczema | Skin and subcutaneous tissue disorders | Ampicillin Sodium/Sulbactam Sodium | 2 | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ampicillin Sodium/Sulbactam Sodium | ||
| Total, other adverse events | Ampicillin Sodium/Sulbactam Sodium | 19 | 47 |
| Total, serious adverse events | Ampicillin Sodium/Sulbactam Sodium | 1 | 47 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01189487
GET https://conductscience.org/api/trials/v1/NCT01189487/registered