{"id":2233,"date":"2016-01-02T03:48:37","date_gmt":"2016-01-02T08:48:37","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=2233"},"modified":"2016-03-23T04:39:08","modified_gmt":"2016-03-23T08:39:08","slug":"new-treatment-guidelines-for-candidiasis-a-major-document-to-study","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2016\/01\/02\/2233\/new-treatment-guidelines-for-candidiasis-a-major-document-to-study\/","title":{"rendered":"New Treatment Guidelines for Candidiasis \u2013 A Major Document to Study"},"content":{"rendered":"

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

In a much-quoted analysis, Lee found that most IDSA Guidelines were supported only by Level III quality data, the lowest category of evidence-based support[1]<\/a>. The article concludes that more well-designed trials were needed, and clinical judgement should ultimately guide patient management.<\/p>\n

This all sounds fine and good, and the new Candida Guideline by Pappas et. al. has a similar disclaimer[2]<\/a>.\u00a0 However, the reality of medical practice is different. A guideline is not like a textbook chapter or article but has greater formative authority.\u00a0 That said, in a litigious society like ours, any deviation from chapter and verse of this \u2018bible\u2019 becomes a potential lawsuit, with the physician having to explain why (s)he deviated from expert recommendations by omission or commission.\u00a0 In other words, use your \u2018judgement\u2019 at your own risk.<\/p>\n

It is a fallacy to blame the data situation for many poorly supported recommendations.\u00a0 We will never have \u201cwell-controlled\u201d trials in some of the rare conditions described in the Guideline, hence, treatment decisions will have to be made based on extrapolation and inference from more common conditions.\u00a0 Over 50% of recommendations are, like in the Lee review, based on rather poor data, and the next version of the Guidelines will probably be no different again.\u00a0 Common sense justifies most of the recommendations, even if these were not supportable by high quality data, low quality data, or no data at all. \u00a0Which is why, on the back of this document, we should see a banner stating the following:\u00a0 In Experts We Trust.<\/strong><\/span><\/p>\n

It should not come as a surprise that most of the \u201cstrong recommendations\u201d supported by \u201dstrong data\u201d come from registration trials conducted by industry for new antifungals. These trials were conducted in mucosal candidiasis or candidemia for which patient recruitment into well-controlled trials was feasible.<\/p>\n

It\u2019s a pity that NIH and other similar sponsors have been much less important contributors to the clinical data situation.\u00a0 As industry runs trials with the same experts that later write our Guidelines, there is potential for conflict of interest, which we all need to be aware of.<\/p>\n

FDA has a conflict of interest policy that pretty much prohibits these same experts from sitting on regulatory decision bodies, variously called AIDAC or AMDAC.\u00a0 That\u2019s a good thing and should not be changed.\u00a0 Many of my colleagues argue that this \u2018no conflict\u2019 rule robs FDA of important expertise.\u00a0 Yes and no, there is a trade-off, of course.\u00a0 Democratic societies choose to keep the executive, legislative and judicial powers separate in government.\u00a0 Our panel experts already have strong influence in the clinical arena and are often expert witnesses in the judicial system; they should not be the regulatory decision makers too.\u00a0 The conflict of interest section at the end of the Guideline is amazingly long; it would certainly take up a full page if the type font were not reduced.<\/p>\n

Thorough study of this new Guideline document easily takes a full day. IDSA should award at least 8 hours of CME credits for this 50 page monster of a document.\u00a0 Correction: the actual text is merely 38 pages long; the 560 references make up the rest.\u00a0 If you are willing to skip recommendations based on low-quality evidence, i.e., those more faith-based instead of evidence-based recommendations, you can pretty much eliminate 2\/3 of the document making it more readable and better digestible.<\/p>\n

By design, Guidelines are fairly dry and boring documents, so here some suggestions to spice it up a bit.\u00a0 Try figuring out why there are so many \u201cstrong recommendation, low quality data\u201d recommendations.\u00a0 More importantly, the sections justifying recommendations are very insightful. There are some other \u2018pearls\u2019 too.\u00a0 The comment that isavuconazole may\u00a0not have shown non-inferiority against an echinocandin is so far unpublished information.\u00a0 It explains why Cresemba is hardly mentioned in this Guidance document.<\/p>\n

Spoiler alert: In the treatment category, it\u2019s about azoles, echinocandins and AmB formulations.\u00a0 You already knew that?\u00a0 Well, you are ahead of the curve.<\/p>\n

Another spoiler alert: AmB is still toxic and should be avoided unless you have a good lawyer.<\/p>\n

Last spoiler alert: You can use fluconazole IF you can predict that it will work.\u00a0 Hmmh\u2026<\/p>\n

(Sorry folks: Garlic \/ allicin is not a treatment option for anything)<\/p>\n

 <\/p>\n

References:<\/strong>
\n[1]<\/a>\u00a0Lee, D. Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines\u00a0 JAMA Internal Medicine 2011, Vol 171, No. 1
\n[2]<\/a> Pappas, P. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America.\u00a0 Clinical Infectious Diseases Advance Access. Published Dec 16, 2015<\/p>\n","protected":false},"excerpt":{"rendered":"

In a much-quoted analysis, Lee found that most IDSA Guidelines were supported only by Level III quality data, the lowest category of evidence-based support[1]. The article concludes that more well-designed trials were needed, and clinical judgement should ultimately guide patient management. This all sounds fine and good, and the new Continue reading New Treatment Guidelines for Candidiasis \u2013 A Major Document to Study<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":2237,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[227,3,18],"tags":[778,1492,1271,1404,403,225,1499,1486,1497,1489,1490,942,1484,5,1495,1493,1583,27,1485,610,1498,1488,1496,1500,1491,1487,928],"class_list":["post-2233","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recent_literature","category-the_news","category-the_viewpoint","tag-aidac","tag-allicin","tag-allphase-pharma-consulting","tag-amdac","tag-antibiotic-blog","tag-azole","tag-candidemia","tag-candidiasis","tag-caspofungin","tag-clinical-practice-guideline","tag-conflict-of-interest","tag-cresemba","tag-echinocandin","tag-fda","tag-fluconazole","tag-garlic","tag-harald-reinhart","tag-idsa","tag-idsa-guideline","tag-isavuconazole","tag-liposomal-amphotericin-b","tag-management-of-candida-infection","tag-micafungin","tag-mucosal-candidiasis","tag-strength-of-recommendations","tag-treatment-of-candida-infection","tag-voriconazole"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/01\/InExpertsWeTrust.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-A1","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":2625,"url":"https:\/\/allphasepharma.com\/dir\/2016\/07\/13\/2625\/aspergillus_guideline-zip\/","url_meta":{"origin":2233,"position":0},"title":"Aspergillus_Guideline.ZIP","author":"Harald","date":"July 13, 2016","format":false,"excerpt":"Now, I know we should not make light of any IDSA Guidelines, far from it. 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For treatment-na\u00efve patients with GT1,\u2026","rel":"","context":"In "The Viewpoint"","block_context":{"text":"The Viewpoint","link":"https:\/\/allphasepharma.com\/dir\/category\/the_viewpoint\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":4964,"url":"https:\/\/allphasepharma.com\/dir\/2025\/08\/15\/4964\/new-idsa-cuti-guideline\/","url_meta":{"origin":2233,"position":2},"title":"NEW IDSA cUTI GUIDELINE","author":"Harald","date":"August 15, 2025","format":false,"excerpt":"A new Guideline for the treatment of cUTI just arrived.[1] First, we are glad that this somewhat mundane topic receives the attention it deserves.\u00a0 UTIs are often downplayed as minor infections, but the cUTI variety should not be taken lightly.\u00a0 Many patients still are admitted with life-threatening infections, so prompt\u2026","rel":"","context":"In "The News"","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/cUTI-classification.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/cUTI-classification.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/cUTI-classification.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/cUTI-classification.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/cUTI-classification.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":222,"url":"https:\/\/allphasepharma.com\/dir\/2014\/05\/30\/222\/hiv-therapy-guidance-recommendations-diverge-show-us-bias\/","url_meta":{"origin":2233,"position":3},"title":"HIV Therapy Guidance Recommendations Diverge, Show US Bias","author":"Harald","date":"May 30, 2014","format":false,"excerpt":"US doctors seem to be very willing to start drugs earlier in disease, while their EU colleagues are slower and more conservative.\u00a0 Recent examples: the ever-wider indication for statins, the disproportionate uptake of drugs for attention-deficit \/ hyperactivity and opioids for pain relief.\u00a0 The new US HIV treatment guidelines are\u2026","rel":"","context":"In "The Viewpoint"","block_context":{"text":"The Viewpoint","link":"https:\/\/allphasepharma.com\/dir\/category\/the_viewpoint\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":5569,"url":"https:\/\/allphasepharma.com\/dir\/2025\/10\/16\/5569\/the-antifungal-landscape-1\/","url_meta":{"origin":2233,"position":4},"title":"The Antifungal Landscape – 1","author":"Harald","date":"October 16, 2025","format":false,"excerpt":"Some newer azoles are still in development, but most only target candidiasis.\u00a0 Many years ago we saw development of nikkomycin (Nik Z), a drug mainly for coccidioidomycosis (Valley Fever).\u00a0 It has no appreciable activity against candida or aspergillus.\u00a0 Then there is ibrexafungerp, a promising new agent against C. albicans and\u2026","rel":"","context":"In "Recent Literature"","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/10\/antigungals-table.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/10\/antigungals-table.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/10\/antigungals-table.jpg?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":2396,"url":"https:\/\/allphasepharma.com\/dir\/2016\/03\/23\/2396\/the-cresemba-candidemia-gamble-rien-ne-va-plus\/","url_meta":{"origin":2233,"position":5},"title":"The Cresemba Candidemia Gamble \u2013 Rien Ne Va Plus","author":"Harald","date":"March 23, 2016","format":false,"excerpt":"Isavuconazole is a potent triazole; like Voriconazole, it has garnered an indication for invasive aspergillosis. 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