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

• 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: Pfizer
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ampicillin Sodium/Sulbactam Sodium
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

Baseline Characteristics

Arm/Group Title		Ampicillin Sodium/Sulbactam Sodium
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
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%

Outcome Measures

1. Primary Outcome

Title	Response Rate (Clinical Response, Data Review Committee Assessment)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)
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)

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kohno S, Tateda K, Mikamo H, Kadota J, Niki Y, Itamura R. Efficacy and safety of intravenous sulbactam/ampicillin 3 g 4 times daily in Japanese adults with moderate to severe community-acquired pneumonia: a multicenter, open-label, uncontrolled study. J Infect Chemother. 2015 Mar;21(3):182-8. doi: 10.1016/j.jiac.2014.11.006. Epub 2014 Nov 20.

Soto E, Shoji S, Muto C, Tomono Y, Marshall S. Population pharmacokinetics of ampicillin and sulbactam in patients with community-acquired pneumonia: evaluation of the impact of renal impairment. Br J Clin Pharmacol. 2014 Mar;77(3):509-21. doi: 10.1111/bcp.12232.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01189487
• 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