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Acute or Chronic Bacterial Prostatitis
Current Classification System (Drach et al)
NIH Consensus Conference on Prostatitis (1995)
NIH Consensus Conference on Prostatitis cont.
Quinolone Antimicrobials with a prostatitis indication
Disease Definitions Kunin Calvin M.: Urinary Tract Infections, Detection, Prevention, and Management. Fifth edition, 1997.
Evaluability Issues
Evaluability Issues cont..
Inclusion Criteria
Inclusion Criteria cont.
Bacteriologic Assessment #11; Sequential urine cultures (Mears and Stamey)
Bacteriologic Assessment cont.
Exclusion Criteria
Unevaluable
Baseline Visit (pre-therapy, screening and start of therapy visit)
On-therapy Visit
FDA TOC Visit #11; 5 – 9 days post-End Of Therapy (EOT)
End Of Study (EOS) Visit 4 – 6 weeks after the EOT
Outcome Assessment
Outcome Assessment cont.
Outcome Assessment Clinical #11; (TOC = 5 -9 days post-therapy)
Outcome Assessment Clinical
Outcome Assessment #11; Microbiological (TOC = 5 -9 days post-therapy)
Outcome Assessment #11; 4-6 weeks post-therapy
Outcome Assessment #11; Clinical (4 - 6 weeks post-therapy)
Microbiologic Assessment #11; (4-6 weeks post-therapy)
Proposal
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Last update: July 8, 2005
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