Trial Outcomes & Findings for The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP) (NCT NCT01189487)
NCT ID: NCT01189487
Last Updated: 2012-07-13
Results Overview
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.
COMPLETED
PHASE3
47 participants
End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
2012-07-13
Participant Flow
Participant milestones
| Measure |
Ampicillin Sodium/Sulbactam Sodium
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ampicillin Sodium/Sulbactam Sodium
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Baseline characteristics by cohort
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=47 Participants
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Age Continuous
|
62.3 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)Population: 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.
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.
Outcome measures
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=40 Participants
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Response Rate (Clinical Response, Data Review Committee Assessment)
End of treatment (n=39)
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
|
Response Rate (Clinical Response, Data Review Committee Assessment)
Test of cure (n=37)
|
94.6 percentage of participants
Interval 81.8 to 99.3
|
|
Response Rate (Clinical Response, Data Review Committee Assessment)
Long term follow up (n=36)
|
94.4 percentage of participants
Interval 81.3 to 99.3
|
SECONDARY outcome
Timeframe: End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)Population: 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.
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.
Outcome measures
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=40 Participants
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Response Rate (Clinical Response, Investigator Assessment)
End of treatment (n=40)
|
100.0 percentage of participants
Interval 91.2 to 100.0
|
|
Response Rate (Clinical Response, Investigator Assessment)
Test of cure (n=38)
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
|
Response Rate (Clinical Response, Investigator Assessment)
Long term follow up (n=34)
|
100.0 percentage of participants
Interval 89.7 to 100.0
|
SECONDARY outcome
Timeframe: Day 4Population: 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.
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.
Outcome measures
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=40 Participants
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
The Tendency Toward Clinical Improvement (Investigator Assessment)
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)Population: 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.
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.
Outcome measures
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=28 Participants
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Day 4 (n=24)
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
End of treatment (n=25)
|
96.0 percentage of participants
Interval 79.6 to 99.9
|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Test of cure (n=24)
|
91.7 percentage of participants
Interval 73.0 to 99.0
|
|
Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Long term follow up (n=21)
|
95.2 percentage of participants
Interval 76.2 to 99.9
|
SECONDARY outcome
Timeframe: Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)Population: 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.
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.
Outcome measures
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=28 Participants
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
Day 4 (n=23)
|
95.7 percentageof participants
Interval 78.1 to 99.9
|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
End of treatment (n=24)
|
100.0 percentageof participants
Interval 85.8 to 100.0
|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
Test of cure (n=23)
|
95.7 percentageof participants
Interval 78.1 to 99.9
|
|
Eradication Rate (Bacteriological Response, Investigator Assessment)
Long term follow up (n=19)
|
100.0 percentageof participants
Interval 82.4 to 100.0
|
Adverse Events
Ampicillin Sodium/Sulbactam Sodium
Serious adverse events
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=47 participants at risk
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Infections and infestations
Pneumonia
|
2.1%
1/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Ampicillin Sodium/Sulbactam Sodium
n=47 participants at risk
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
10.6%
5/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
14.9%
7/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
12.8%
6/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.5%
4/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.4%
3/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
2/47
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
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