{"id":1869,"date":"2015-08-19T09:18:44","date_gmt":"2015-08-19T13:18:44","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1869"},"modified":"2016-04-21T21:51:08","modified_gmt":"2016-04-22T01:51:08","slug":"most-anti-infective-guidelines-get-no-respect-let-alone-use","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2015\/08\/19\/1869\/most-anti-infective-guidelines-get-no-respect-let-alone-use\/","title":{"rendered":"Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)"},"content":{"rendered":"

\"indications<\/a><\/p>\n

It is no secret that most existing antibiotic guidelines are not getting much use these days.\u00a0 The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.\u00a0 Yes, the occasional HABP\/VABP trial is being undertaken by the intrepid but no company has taken up the FDA on its offer to garner the ABOM, ABECB, or ABECS indication by running a placebo-controlled superiority trials.<\/p>\n

Here the current list of existing FDA Guidances[1]<\/a>, [2]<\/a>\u00a0which I am separating into 2 categories:<\/p>\n

    \n
  1. CLASSICAL ORGAN INDICATIONS\n
      \n
    1. Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment 10\/1\/2012\u00a0[3]<\/a><\/li>\n
    2. Acute Bacterial Sinusitis: Developing Drugs for Treatment 10\/05\/12<\/li>\n
    3. Acute Bacterial Otitis Media: Developing Drugs for Treatment 10\/2\/2012<\/li>\n
    4. Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment 10\/23\/2013<\/li>\n
    5. Acute Bacterial Sinusitis: Developing Drugs for Treatment 10\/9\/2012<\/li>\n
    6. Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment (I) 7\/22\/1998<\/li>\n
    7. Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment (I) 8\/27\/2010<\/li>\n
    8. Community-Acquired Pneumonia \u2014 Developing Antimicrobial Drugs for Treatment 1\/10\/2014<\/li>\n
    9. Complicated Intra-Abdominal Infections: Developing Drugs for Treatment 10\/1\/2012<\/li>\n
    10. Complicated Urinary Tract Infections: Developing Drugs for Treatment 2\/24\/2012<\/li>\n
    11. Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment 5\/7\/2014<\/li>\n
    12. Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment (I) 10\/15\/2007<\/li>\n<\/ol>\n<\/li>\n
    13. SINGLE PATHOGEN INDICATIONS\n
        \n
      1. Catheter-Related Bloodstream Infections – Developing Antimicrobial Drugs for Treatment (I) 10\/18\/1999<\/li>\n
      2. Uncomplicated Gonorrhea — Developing Antimicrobial Drugs for Treatment 6\/19\/2014<\/li>\n
      3. Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (I) 10\/5\/2009<\/li>\n
      4. Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post Exposure) 03\/15\/02<\/li>\n
      5. Pulmonary Tuberculosis: Developing Drugs for Treatment 11\/05\/13<\/li>\n
      6. Surprisingly, there is no Guidance for C. difficile infections although Fidaxomicin has blazed a path that others will follow.<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

        Looking at recently approved drugs and the indications they pursued shows that most companies choose the easy the path, with feasibility trumping risk-taking. The ABSSSI indication is the all-time favorite, for obvious reasons (feasibility, low cost):<\/p>\n