StudyConsiderationsAcuteBacterialOtitisMedia.pptVIP

FDA AIDAC 7/11/02 Study Considerations: Acute Bacterial Otitis Media Recurrent / Treatment Failure Rosemary Johann-Liang, M.D. Division of Special Pathogen and Immunological Drug Products Study Considerations: Revisiting the Guidance Targeted Populations: AOM Current Draft Guidance Proposal for change Discussion of definitions Types of Trials Items for Discussion 1998 Draft Guidance / 1992 Points-to-Consider One indication: AOM Exclusion Criteria includes systemic anti-infective drug product in the previous 7 days prior to enrollment (clinical-only study) systemic anti-infective drug product in the previous 3 days prior to enrollment (clinical/microbiological study) patient receiving antimicrobial prophylaxis for recurrent otitis media penicillins/aminopenicillins, cephalosporins, macrolides approved with all-comers with above exclusions Proposal for change Recent AIDAC Advice Dr. Leggett (11/2001) “...there was a thing about not being able to use antibiotics within the last 7 days of the last month. I think that would be another way to actually enrich the resistant population because isn’t that who we have the trouble with, the more severe illness and the more resistant pathogens?” Dr. Wald (11/2001) “....I think that groups of children that we should be studying are children with severe disease..” Proposal for change Challenge of antibiotic resistance Underlying factor: PRSP (diagram not to scale) Proposal for change  Proposal for change Drug Development, “High-Dose”Augmentin Developed w/ PRSP in mind Some enrichment stategies used to maximize patients with bacterial AOM esp. PRSP Label: Augmentin ES-600? “..is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media .........characterized by the following risk factors: antibiotic exposure for AOM within the preceding 3 months, AND either of the following: age 2 years, daycare attendance” This “recurrent or persistent” sub-population not pre-defined