Limitations of outpatient clinical studies in respiratory tract infections

7/19/02


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Table of Contents

PPT Slide

Limitations of outpatient clinical studies in respiratory tract infections

1977 FDA Guidance on AOM

Objectives

Impact of limited clinical data and increasing pathogen resistance on choice of antibacterial therapy

Evaluating antibacterial efficacy using pharmacokinetics and pharmacodynamics

PPT Slide

Drug Pharmacokinetics in blood

Pharmacokinetic Parameters

Patterns of antibacterial activity

Time Above MIC: ?-Lactams

Relationship between Time above MIC and efficacy in animal infection models infected with S. pneumoniae

24-hr AUC/MIC and Peak/MIC Ratios Correlation of serum pharmacokinetics with MIC (susceptibility) of an organism

Relationship between 24 Hr AUC/MIC and mortality for fluoroquinolones against S. pneumoniae in immunocompetent animals

S. pneumoniae and H. influenzae pneumonia in rats: ED50 based on ? 3 log10 reduction in cfu/lung

PPT Slide

Relationship between Time above MIC and bacterial eradication with ?-lactams in otitis media

Relationship between Time above MIC and bacterial eradication with ?-lactams in maxillary sinusitis

PPT Slide

Pharmacodynamic breakpoints (g/ml) for oral agents used for RTIs

Pharmacodynamic vs. NCCLS breakpoints (values in g/ml)

Susceptibility of US Isolates at PK/PD breakpoints

Amoxicillin-clavulanate

Cefaclor

Cefuroxime axetil

Cefprozil

Cefixime

Azithromycin

Clarithromycin

Clindamycin

Telithromycin

Doxycycline

Ciprofloxacin

Levofloxacin

Trimethoprim-sulfamethoxazole

Conclusions: antibacterial choice for empiric use in RTI

1977 FDA Guidance on AOM

New FDA Guidance on AOM