The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

• ClinicalTrials.gov Identifier: NCT00809328
• Recruitment Status: Completed
• First Posted: December 17, 2008
• Results First Posted: April 13, 2011
• Last Update Posted: May 19, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Community Acquired Pneumonia (CAP)
• Intervention: Drug: Azithromycin
• Enrollment: 102

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
Period Title: Overall Study
Started	102
Completed	73
Not Completed	29
Reason Not Completed
Lack of Efficacy	18
Adverse Event	6
Protocol Violation	3
Withdrawal by Subject	2

Baseline Characteristics

Arm/Group Title		Azithromycin
Arm/Group Description		Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
Overall Number of Baseline Participants		102
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	102 participants
		55.4 (18.6)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	102 participants
	Female	39 38.2%
	Male	63 61.8%

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, Day 15 and Day 29

Outcome Measure Data

Analysis Population Description

Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. "n " in the measured values means total participants excluding ones assessed as indeterminate.

Arm/Group Title	Azithromycin
Arm/Group Description:	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
Overall Number of Participants Analyzed	73
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
End of Treatment (n=73)	86.3; (76.2 to 93.2)
Day 15 (Primary analysis ) (n=71)	84.5; (74.0 to 92.0)
Day 29 (n=70)	82.9; (72.0 to 90.8)

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, Day 15 and Day 29

Outcome Measure Data

Analysis Population Description

Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. "n " in the measured values means total participants excluding ones assessed as indeterminate.

Arm/Group Title	Azithromycin
Arm/Group Description:	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
Overall Number of Participants Analyzed	73
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
End of Treatment (n=73)	80.8; (69.9 to 89.1)
Day 15 (n=62)	98.4; (91.3 to 100.0)
Day 29 (n=61)	95.1; (86.3 to 99.0)

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 3, and was determined to continue the treatment.
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

Clinical per protocol set consisted of all subjects who received at least one dose of the study drug, have no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data.

Arm/Group Title	Azithromycin
Arm/Group Description:	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
Overall Number of Participants Analyzed	73
Measure Type: Number; Unit of Measure: participants
	68

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
Time Frame	Day 3, End of Treatment, Day 15 and Day 29

Outcome Measure Data

Analysis Population Description

Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. "n " in the measured values was the total participants EXCLUDING ones assessed as indeterminate.

Arm/Group Title	Azithromycin
Arm/Group Description:	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
Overall Number of Participants Analyzed	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Day 3 (n=28)	71.4; (51.3 to 86.8)
End of Treatment (n=31)	80.6; (62.5 to 92.5)
Day 15 (n=30)	83.3; (65.3 to 94.4)
Day 29 (n=30)	83.3; (65.3 to 94.4)

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
Time Frame	Day 3, End of Treatment, Day 15 and Day 29

Outcome Measure Data

Analysis Population Description

Bacteriologic per protocol set consisted of all subjects in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. "n " in the measured values was the total participants EXCLUDING ones assessed as indeterminate.

Arm/Group Title	Azithromycin
Arm/Group Description:	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
Overall Number of Participants Analyzed	33
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentageof participants
Day 3 (n=27)	74.1; (53.7 to 88.9)
End of Treatment (n=29)	86.2; (68.3 to 96.1)
Day 15 (n=25)	100.0; (86.3 to 100.0)
Day 29 (n=25)	100.0; (86.3 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	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
All-Cause Mortality
	Azithromycin
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Azithromycin
	Affected / at Risk (%)
Total	8/102 (7.84%)
Cardiac disorders
Cardiac failure congestive † 1	1/102 (0.98%)
Infections and infestations
Peritonsillar abscess † 1	1/102 (0.98%)
Pneumonia † 1	3/102 (2.94%)
Investigations
Prothrombin time prolonged † 1	1/102 (0.98%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant † 1	1/102 (0.98%)
Respiratory, thoracic and mediastinal disorders
Organising pneumonia † 1	1/102 (0.98%)
Pneumothorax † 1	1/102 (0.98%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 12.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	2%
	Azithromycin
	Affected / at Risk (%)
Total	33/102 (32.35%)
Gastrointestinal disorders
Constipation † 1	8/102 (7.84%)
Diarrhoea † 1	15/102 (14.71%)
General disorders
Injection site erythema † 1	3/102 (2.94%)
Injection site pain † 1	6/102 (5.88%)
Musculoskeletal and connective tissue disorders
Back pain † 1	3/102 (2.94%)
Nervous system disorders
Headache † 1	8/102 (7.84%)
Psychiatric disorders
Insomnia † 1	6/102 (5.88%)
Respiratory, thoracic and mediastinal disorders
Haemoptysis † 1	3/102 (2.94%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 12.1

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, Kadota J, Fujita J, Niki Y, Watanabe A, Nagashima M. Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia. J Infect Chemother. 2014 Mar;20(3):199-207. doi: 10.1016/j.jiac.2013.10.010. Epub 2013 Dec 11.

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• ClinicalTrials.gov Identifier: NCT00809328
• Other Study ID Numbers: A0661191
• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Results First Submitted: March 22, 2011
• Results First Posted: April 13, 2011
• Last Update Posted: May 19, 2011