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The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)

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ClinicalTrials.gov Identifier: NCT01189487
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : May 18, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pneumonia, Bacterial
Intervention Drug: ampicillin sodium/sulbactam sodium
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Period Title: Overall Study
Started 47 [1]
Completed 44
Not Completed 3
Reason Not Completed
Lack of Efficacy             2
Adverse Event             1
[1]
Treated participants
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
62.3  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
21
  44.7%
Male
26
  55.3%
1.Primary Outcome
Title Response Rate (Clinical Response, Data Review Committee Assessment)
Hide Description 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.
Time Frame End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description:
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
End of treatment (n=39)
97.4
(86.5 to 99.9)
Test of cure (n=37)
94.6
(81.8 to 99.3)
Long term follow up (n=36)
94.4
(81.3 to 99.3)
2.Secondary Outcome
Title Response Rate (Clinical Response, Investigator Assessment)
Hide Description 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.
Time Frame End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description:
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Overall Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
End of treatment (n=40)
100.0
(91.2 to 100.0)
Test of cure (n=38)
100.0
(90.7 to 100.0)
Long term follow up (n=34)
100.0
(89.7 to 100.0)
3.Secondary Outcome
Title The Tendency Toward Clinical Improvement (Investigator Assessment)
Hide Description 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.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description:
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
100.0
4.Secondary Outcome
Title Eradication Rate (Bacteriological Response, Data Review Committee Assessment)
Hide Description 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.
Time Frame Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description:
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 4 (n=24)
100.0
(85.8 to 100.0)
End of treatment (n=25)
96.0
(79.6 to 99.9)
Test of cure (n=24)
91.7
(73.0 to 99.0)
Long term follow up (n=21)
95.2
(76.2 to 99.9)
5.Secondary Outcome
Title Eradication Rate (Bacteriological Response, Investigator Assessment)
Hide Description 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.
Time Frame Day 4, End of treatment, Test of cure (7 days after End of treatment), Long term follow up (7 days after Test of cure)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description:
Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentageof participants
Day 4 (n=23)
95.7
(78.1 to 99.9)
End of treatment (n=24)
100.0
(85.8 to 100.0)
Test of cure (n=23)
95.7
(78.1 to 99.9)
Long term follow up (n=19)
100.0
(82.4 to 100.0)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Ampicillin Sodium/Sulbactam Sodium
Hide Arm/Group Description Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
All-Cause Mortality
Ampicillin Sodium/Sulbactam Sodium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ampicillin Sodium/Sulbactam Sodium
Affected / at Risk (%)
Total   1/47 (2.13%) 
Infections and infestations   
Pneumonia  1  1/47 (2.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Ampicillin Sodium/Sulbactam Sodium
Affected / at Risk (%)
Total   19/47 (40.43%) 
Gastrointestinal disorders   
Constipation  1  5/47 (10.64%) 
Diarrhoea  1  3/47 (6.38%) 
General disorders   
Pyrexia  1  2/47 (4.26%) 
Infections and infestations   
Nasopharyngitis  1  3/47 (6.38%) 
Investigations   
Alanine aminotransferase increased  1  7/47 (14.89%) 
Aspartate aminotransferase increased  1  6/47 (12.77%) 
Blood alkaline phosphatase increased  1  4/47 (8.51%) 
Gamma-glutamyltransferase increased  1  3/47 (6.38%) 
Nervous system disorders   
Headache  1  2/47 (4.26%) 
Skin and subcutaneous tissue disorders   
Eczema  1  2/47 (4.26%) 
Pruritus  1  2/47 (4.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01189487     History of Changes
Other Study ID Numbers: A9231001
First Submitted: August 16, 2010
First Posted: August 26, 2010
Results First Submitted: April 19, 2012
Results First Posted: May 18, 2012
Last Update Posted: July 13, 2012