The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00809328
First received: December 16, 2008
Last updated: May 16, 2011
Last verified: May 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Community Acquired Pneumonia (CAP) |
Drug: Azithromycin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Response Rate (Clinical Response, Data Review Committee Assessment) [ Time Frame: End of Treatment, Day 15 and Day 29 ] [ Designated as safety issue: No ]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:
- Response Rate (Clinical Response, Investigator Assessment) [ Time Frame: End of Treatment, Day 15 and Day 29 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Enrollment: | 102 |
| Study Start Date: | February 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809328
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:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00809328 History of Changes |
| Other Study ID Numbers: | A0661191 |
| Study First Received: | December 16, 2008 |
| Results First Received: | March 22, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Azithromycin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013