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
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Author: Colin D. Marchant, M.D.
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