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

Tracking Information

• First Submitted Date: December 16, 2008
• First Posted Date: December 17, 2008
• Results First Submitted Date: March 22, 2011
• Results First Posted Date: April 13, 2011
• Last Update Posted Date: May 19, 2011
• Study Start Date: February 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 22, 2011)

Response Rate (Clinical Response, Data Review Committee Assessment) [ Time Frame: End of Treatment, Day 15 and Day 29 ]

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.

• Original Primary Outcome Measures (submitted: December 16, 2008): The clinical efficacy assessed by Data Review Committee [ Time Frame: at day 15 ]

Current Secondary Outcome Measures (submitted: May 16, 2011)

• Response Rate (Clinical Response, Investigator Assessment) [ Time Frame: End of Treatment, Day 15 and Day 29 ]
  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
• The Tendency Toward Clinical Improvement (Investigator Assessment) [ Time Frame: Day 3 ]
  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.
• Eradication Rate (Bacteriological Response, Data Review Committee Assessment) [ Time Frame: Day 3, End of Treatment, Day 15 and Day 29 ]
  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
• Eradication Rate (Bacteriological Response, Investigator Assessment) [ Time Frame: Day 3, End of Treatment, Day 15 and Day 29 ]
  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

Original Secondary Outcome Measures (submitted: December 16, 2008)

• Data Review Committee's clinical efficacy [ Time Frame: at EOT and Day 29 ]
• Investigator's clinical efficacy [ Time Frame: at EOT, Day 15 and Day 29 ]
• Data Review Committee's bacteriologic efficacy [ Time Frame: at Day 3, EOT, Day 15 and Day 29 ]
• Investigator's bacteriologic efficacy [ Time Frame: at Day 3, EOT, Day 15 and Day 29 ]
• Investigator's the tendency toward clinical improvement [ Time Frame: at Day 3 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
• Official Title: A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Community Acquired Pneumonia (CAP) Requiring Initial Intravenous Therapy
• Brief Summary: Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• 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

The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.

Study Arms

Experimental: Azithromycin

Azithromycin switch therapy (switch from intravenous to oral)

Intervention: Drug: Azithromycin

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2010): 102
• Original Estimated Enrollment (submitted: December 16, 2008): 100
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 16 years of age or older patients with CAP.
• Patients who were diagnosed as moderate in severity.

Exclusion Criteria:

• Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
• Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
• Severe renal dysfunction (creatinine clearance < 30 ml/min).
• Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
• Severe underlying disease.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00809328
• Other Study ID Numbers: A0661191
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2011