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 Description

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.

Condition or disease	Intervention/treatment	Phase
Community Acquired Pneumonia (CAP)	Drug: Azithromycin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: February 2009
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Azithromycin; Azithromycin switch therapy (switch from intravenous to oral)	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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.
3. 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
4. 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

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Japan

Pfizer Investigational Site

Seto-shi, Aichi-ken, Japan

Pfizer Investigational Site

Touon, Ehime, Japan

Pfizer Investigational Site

Chikushino, Fukuoka, Japan

Pfizer Investigational Site

Koga, Fukuoka, Japan

Pfizer Investigational Site

Yanagawa, Fukuoka, Japan

Pfizer Investigational Site

Higashihiroshima, Hiroshima, Japan

Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

Pfizer Investigational Site

Himejishi, Hyogo, Japan

Pfizer Investigational Site

Moriya-city, Ibaraki, Japan

Pfizer Investigational Site

Kanazawa, Ishikawa, Japan

Pfizer Investigational Site

Takamatsu, Kagawa, Japan

Pfizer Investigational Site

Kawasaki-city, Kanagawa, Japan

Pfizer Investigational Site

Tsu, Mie, Japan

Pfizer Investigational Site

Sendai, Miyagi, Japan

Pfizer Investigational Site

Matsumoto, Nagano, Japan

Pfizer Investigational Site

Emukae, Kitamatsuura, Nagasaki, Japan

Pfizer Investigational Site

Isahaya, Nagasaki, Japan

Pfizer Investigational Site

Nagasaki-city, Nagasaki, Japan

Pfizer Investigational Site

Sasebo City, Nagasaki, Japan

Pfizer Investigational Site

Niigata-shi, Niigata-ken, Japan

Pfizer Investigational Site

Oita City, Oita, Japan

Pfizer Investigational Site

Yufu, Oita, Japan

Pfizer Investigational Site

Kurashiki, Okayama, Japan

Pfizer Investigational Site

Sakai, Osaka, Japan

Pfizer Investigational Site

Ureshinoshi, Sagaken, Japan

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Pfizer Investigational Site

Meguro-Ku, Tokyo, Japan

Pfizer Investigational Site

Toshima-ku, Tokyo, Japan

Pfizer Investigational Site

Yonezawa, Yamagata, Japan

Pfizer Investigational Site

Fukuoka, Japan

Pfizer Investigational Site

Hiroshima, Japan

Pfizer Investigational Site

Kochi, Japan

Pfizer Investigational Site

Okinawa, Japan

Pfizer Investigational Site

Shiogama-city, Japan

Sponsors and Collaborators

Pfizer

Investigators

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

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

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 Posted: December 17, 2008
• Results First Posted: April 13, 2011
• Last Update Posted: May 19, 2011
• Last Verified: May 2011

Additional relevant MeSH terms:

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Azithromycin; Anti-Bacterial Agents; Anti-Infective Agents