Treatment of Acute Otitis Media With Azithromycin

11/8/01


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Table of Contents

Treatment of Acute Otitis Media With Azithromycin

Azithromycin for Acute Otitis Media Rationale

Azithromycin for Acute Otitis Media Rationale

Azithromycin for Acute Otitis Media Rationale

Azithromycin for Acute Otitis Media Rationale

Advantages of Single Dose Azithromycin

Azithromycin for Acute Otitis Media

Azithromycin: The First Azalide Antibiotic

Azithromycin Uptake by White Blood Cells

Acute Otitis Media Histopathology

Azithromycin Serum and Middle Ear Fluid Levels in Children

Azithromycin for Acute Otitis Media

Azithromycin: In Vitro Activity

Azithromycin: In Vitro Activity

Antimicrobial Resistance to S. pneumoniae According to Penicillin Susceptibility, 1998

Antimicrobial Susceptibility of S. pneumoniae by Age Group

Susceptibility of S. pneumoniae to Macrolides and Penicillin in the U.S. From Surveillance Studies

Azithromycin Bactericidal Activity Against Streptococcus pneumoniae*

Azithromycin Bactericidal Activity Against Haemophilus influenzae*

Azithromycin Chinchilla Model of AOM due to H. influenzae

Azithromycin Chinchilla Middle Ear Fluid Concentrations

Azithromycin Chinchilla Model of AOM due to H. influenzae

Azithromycin Chinchilla Model of AOM due to H. influenzae

Azithromycin for Acute Otitis Media

Azithromycin 5 Day Program Clinical Outcome at Day 30*

Azithromycin 5 Day Program Clinical Success by Baseline Pathogen at Day 30

Azithromycin 5 Day Program Treatment Related Adverse Events*

Azithromycin for Acute Otitis Media

Regimens Used in Azithromycin Clinical Program for Treatment of Acute Otitis Media

1998 FDA Guidance Acute Otitis Media

Azithromycin Overview of Single Dose and Three Day Programs

Single Dose Program

Single Dose Program Inclusion Criteria: Symptoms

Single Dose Program Inclusion Criteria: Signs of Tympanic Membrane Disease

Single Dose Program Key Exclusion Criteria

Single Dose Program Statistical Methods

Single Dose Program Statistical Methods

Single Dose Program Definition of Cure

Study 95-001

Study 95-001 Methods

Study 95-001 Experimental Design

Study 95-001 Patient Disposition

Study 95-001 Demographics

Study 95-001 Results

Study 95-001 Clinical Efficacy Population

Study 95-001 Clinical Outcome at Day 28 by Age

Study 95-001 Susceptibility

Study 95-001 Clinical Cure Per Baseline Pathogen at Day 28

Study 95-001 Treatment Related Adverse Events*

Study R-0581

Study R-0581

Study R-0581 Visits and Assessments

Study R-0581 Patient Disposition

Study R-0581 Demographics

Study R-0581 Results

Study R-0581 Clinical Outcome

Study R-0581 Clinical Outcome at Day 28 by Age

Study R-0581 Compliance

Study R-0581 Treatment Related Adverse Events*

Study 1015

Study 1015

Study 1015 Visits and Assessments

Study 1015 Endpoints

Study 1015 Patient Disposition

Study 1015 Demographics

Study 1015 Results

Study 1015 Clinical Outcome

Study 1015 Clinical Outcome at Day 28 by Age

Study 1015 Clinical Outcome - Per Baseline Pathogen

Study 1015 MIC Distribution for S. pneumoniae (N=67)

Study 1015 Resistant S. Pneumoniae

Study 1015 Day 28 Outcome and MIC Distribution for S. pneumoniae (N=66)

Study 1015 Patient 0067 Failed Therapy

Study 1015 Strains From Patient 0067 Are Clonally Distinct

Study 1015 Outcome of S. pneumoniae AOM by Penicillin Susceptibility

Study 1015 Outcome of S. pneumoniae AOM by Penicillin Susceptibility

Study 1015 Treatment Related Adverse Events*

Study 1014

Study 1014

Study 1014 Inclusion Criteria: Symptoms

Study 1014 Inclusion Criteria: Signs of Tympanic Membrane Involvement

Study 1014 Key Exclusion Criteria

Study 1014 Visits and Assessments

Study 1014 Statistical Methods

Study 1014 Statistical Methods

Study 1014 Definition of Cure

Study 1014 Patient Disposition

Study 1014 Demographics

Study 1014 Results

Study 1014 Clinical Outcome

Study 1014 Clinical Outcome at Day 28 by Age

Study 1014 Compliance

Study 1014 Treatment Related Adverse Events*

Summary of Clinical Data

Acute Otitis Media Summary Clinical Cure at Day 28

Effect of Age on Clinical Outcome < 2 years of age

Summary of Clinical Trials Clinical Cure by Baseline Pathogen at Day 28

Treatment Related Adverse Events Azithromycin Regimens for AOM Vs. Comparator*

Treatment Related Adverse Events Azithromycin Regimens for AOM Vs. Comparator*

Azithromycin for Acute Otitis Media

Focus on Selected Topics

The Influence of Vomiting on Outcome of Single Dose Therapy

Patients Who Vomited Single Dose Therapy

Azithromycin AUC Values Following 2g and 3g Single Doses

Historical Comparison of Cure Rates at Test of Cure Visit (Day 28)

Azithromycin Vs Beta-lactams Comparative Trials for AOM: Clinical Cure at Day 28

S. pneumoniae Clinical Outcome Test of Cure Visit (Day 17-35)*

H. influenzae Clinical Outcome Test of Cure Visit (Day 17-35)*

Timing of Clinical Assessment

Time to Additional Antibiotic Use

Percent Patients on Analgesics/Antipyretics By Study Day – R-0581

Percent Patients on Analgesics/Antipyretics By Study Day – 1014

Study R-0581 Parental Questionnaire

Timing of Clinical Assessment

Azithromycin Vs Beta-lactams Comparative Trials for AOM: Clinical Success at Day 14

Timing of Clinical Assessment

H. influenzae Clinical Outcome End of Therapy (Day 7-15)*

Azithromycin for Acute Otitis Media

Conclusions Azithromycin for Acute Otitis Media

 Author: COSB