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

Pfizer102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Community Acquired Pneumonia (CAP)

Interventions

AzithromycinDRUG

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

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

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.

Time frame: End of Treatment, Day 15 and Day 29

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: Day 3, End of Treatment, Day 15 and Day 29

Eradication Rate (Bacteriological Response, Investigator Assessment)

Time frame: Day 3, End of Treatment, Day 15 and Day 29

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Seto-shi, Aichi-ken, Japan

Pfizer Investigational Site

Touon, Ehime, Japan

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Pfizer Investigational Site

Koga, Fukuoka, Japan

Pfizer Investigational Site

Yanagawa, Fukuoka, Japan

Pfizer Investigational Site

Higashihiroshima, Hiroshima, Japan

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

Pfizer Investigational Site

Himejishi, Hyōgo, Japan

...and 24 more locations