Development of Antibiotics for Otitis Media: Past, Present, and Future. Janice Soreth, M.D. Director Division of Anti-Infective Drug Products. Outline of the Past and Present. 1977 Guidance 1992 Points-to-Consider Document 1992 IDSA/FDA Guidelines 1998 FDA Draft Guidance.
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Janice Soreth, M.D.
Division of Anti-Infective Drug Products
single v. multiple?
Bottom line: What do we need, to know the drug works and is safe for children with otitis media?
62% > 1 episode AOM; 17 % > 3
80% > 1 episode AOM; 46 % > 3
“In the absence of culture of middle ear fluid, no specific claim can be made regarding the effectiveness of any anti-infective drug.”
- “clinical only” study (no tympanocentesis at baseline) to establish equivalence to an approved product
- one clinical/microbiologic study with tympanocentesis at baseline
The open micro study should establish acceptable microbial and clinical outcome in at least 25 patients with H. influenzae, in at least 25 patients with S. pneumoniae, and in at least 15 patients with M. catarrhalis.
- a micro study (100 patients)
- a comparative clinical trial (tap optional); double-blind
- a micro study, non-comparative; increase numbers
- a comparative clinical trial
With regard to the microbiologic endpoint:
1998: “Tympanocentesis obtained at the on-therapy visit should not be considered evidence of documented eradication. Rather, a negative culture result may represent antimicrobial suppression.”
2001: “Tympanocentesis obtained on therapy should be the primary microbiologic endpoint.”
Timing of assessment of clinical outcome:
Most informative tap:
Clinical only and Micro studies:
baseline/on-therapy/at time of failure
Question of the day:
What do we need to know,
what constitutes substantial evidence,
that a novel antimicrobial drug works and
is safe for children with otitis media?