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Trial record 1 of 1 for:    A0661191
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The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azithromycin
Hide 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
Arm/Group Title Azithromycin
Hide 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
Hide 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%
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, Day 15 and Day 29
Hide Outcome Measure Data
Hide 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
Hide 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)
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, Day 15 and Day 29
Hide Outcome Measure Data
Hide 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
Hide 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)
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 3, and was determined to continue the treatment.
Time Frame Day 3
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Time Frame Day 3, End of Treatment, Day 15 and Day 29
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Time Frame Day 3, End of Treatment, Day 15 and Day 29
Hide Outcome Measure Data
Hide 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
Hide 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)
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
Hide 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   --/-- 
Hide 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
Hide 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
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: 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