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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Community Acquired Pneumonia (CAP)

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azithromycin<br>Azithromycin switch therapy (switch from intravenous to oral) | Drug: Azithromycin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (Clinical Response, Data Review Committee Assessment) | 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. | End of Treatment, Day 15 and Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate (Clinical Response, Investigator Assessment) | 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 | End of Treatment, Day 15 and Day 29 | 
| The Tendency Toward Clinical Improvement (Investigator Assessment) | 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. | Day 3 | 
| Eradication Rate (Bacteriological Response, Data Review Committee Assessment) | 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 | Day 3, End of Treatment, Day 15 and Day 29 | 
| Eradication Rate (Bacteriological Response, Investigator Assessment) | 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 | Day 3, End of Treatment, Day 15 and Day 29 |