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

Phase 3

Completed

• Conditions: Community Acquired Pneumonia (CAP)
• Interventions: Drug: Azithromycin

• Registration Number: NCT00809328
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Study Start: 2009-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-03-22
• Results First Submitted QC: 2011-03-22
• Results First Posted: 2011-04-13
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azithromycin	Azithromycin	Azithromycin switch therapy (switch from intravenous to oral)

Primary Outcome Measures

Name	Time	Method
Response Rate (Clinical Response, Data Review Committee Assessment)	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

Name	Time	Method
Response Rate (Clinical Response, Investigator Assessment)	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)	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)	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)	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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Shiogama-city, Japan