Design of Clinical Trials of Antibiotic Therapy for Acute Otitis Media

11/8/01


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Table of Contents

Design of Clinical Trials of Antibiotic Therapy for Acute Otitis Media

Outcomes in Trials of Antibacterial Drugs for AOM

Timing of Clinical Outcomes in Trials of Antibiotic Therapy for Acute Otitis Media

Effect of Antibiotic Treatment on Earache in Severe AOM

Treatment of Severe AOM

Amoxicillin vs Placebo for Non-severe AOM

Bacteriology of Clinical Recurrences of AOM 1 Month After Completion of Treatment

Clinical Recurrences of Acute Otitis Media After Therapy

Correlation of Bacteriologic and Clinical Outcomes in Acute Otitis Media after 3-6 days of Antibiotic Therapy

Early eradication of pathogens from middle ear fluid during antibiotic treatment of acute otitis media is associated with improved clinical outcome

Clinical Success Rates in Acute Otitis Media

The Pollyanna Phenomenon Measuring the Efficacy of Anti-bacterial Drugs in Acute Otitis Media

The Pollyanna Phenomenon Measuring the Efficacy of Anti-bacterial Drugs in Acute Otitis Media

Sample Sizes Required to Detect Differences Between Antibacterial Drugs for Acute Otitis Media (AOM): Comparison of Bacteriologic Versus Clinical Outcomes in a Trial of 2 Drugs With Varying Bacteriologic Efficacy (Half the patients would be in each arm of a study)

Parameters Used in Sample Size Calculations

PPT Slide

Sample Sizes Required to Detect Differences Between an Antibacterial Drug with 90% Bacteriologic Efficacy and Drugs with Fair Efficacy (70%), Poor Efficacy (50%), or Tap water (30%) in Clinical Trials of Acute Otitis Media

Sample Size Calculations for Clinical Outcomes

Sample Sizes Required to Detect Differences Between an Antibacterial Drug with 90% Bacteriologic Efficacy and Drugs with No Efficacy (30%) Poor Efficacy (50%), Poor Efficacy (70%), or in Clinical Trials of Acute Otitis Media

Bacteriologic, Symptomatic and “Test of Cure” ** Outcomes in Trials of Antibacterial Therapy in Acute Otitis Media

Sample Sizes Required to Detect Differences Between an Antibacterial Drug with 90% Bacteriologic Efficacy and Drugs with Fair Efficacy (70%), Poor Efficacy (50%), or Tap water (30%) in Clinical Trials of Acute Otitis Media

Timing of Outcomes in Trials Correlating Clinical and Bacterriologic Endpoints in Acute Otitis Media

Bacterial AOM: Bacteriologic, Bacteriologic/Clinical and Clinical Outcomes (“Double Tap”, “Tap and Tap of Clinical Failures”, and “Single Tap” with Clinical End of Therapy and Test of Cure Outcomes)

Sample Sizes Required to Detect Differences Between an Antibacterial Drug with 90% Bacteriologic Efficacy and Drugs with No Efficacy (30%) Poor Efficacy (50%), Fair Efficacy (70%), in Clinical Trials of Bacterial AOM (Tympanocentesis Trials)

Clinical Impact of Drug Efficacy

Clinical Trial Sizes to Distinguish Between Drugs with 90% and 30% Bacteriologic Efficacy The Tap Water Standard

Clinical Trial Sizes to Distinguish Between Drugs with 90% and 30% Bacteriologic Efficacy The Tap Water Standard

Clinical Trial Sizes to Distinguish Between Drugs with 90% and 50% Bacteriologic Efficacy The Poor Drug Standard

Clinical Trial Sizes to Distinguish Between Drugs with 90% and 50% Bacteriologic Efficacy The Poor Drug Standard

Clinical Trial Sizes to Distinguish Between Drugs with 90% and 70% Bacteriologic Efficacy The Fair Drug Standard

Clinical Trial Sizes to Distinguish Between Drugs with 90% and 70% Bacteriologic Efficacy The Fair Drug Standard

Conclusions

Conclusions

Conclusions

Recommendations

Recommendations

Recommendations

Recommendations

Author: Colin D. Marchant, M.D.