[PDF] Thesaurus for off-label indications for systemic antifungal agents

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Un thésaurus pour les indications hors AMM des antifongiques systémiques Thesaurus for off-label indications for systemic antifungal agents

AL Bienvenu

1,2,9*, M Aussedat1, F Maldonado3, R Kavafian3, C Barbieri1, M Tod1,9, C Paillet3,4, L

Juillard

3,5,6, C Chidiac7,8,9, G Leboucher1,9

1 Service Pharmacie, Groupement Hospitalier Nord, Hospices Civils de Lyon, Lyon

2UMR-CNRS 5246, Campus Lyon La Doua, Université de Lyon, Lyon

3 Commission du Médicament et des Dispositifs Médicaux Stériles, Hospices Civils de Lyon, Lyon 4Service Pharmacie, Groupement Hospitalier Centre, Hospices Civils de Lyon, Lyon

5Service de Néphrologie, Groupement Hospitalier Centre, Hospices Civils de Lyon, Lyon 6Univ Lyon1, Université de Lyon, Lyon

7Service des Mal adies In fectieuses et Trop icales, Groupement Hospitalier N ord, Hospices

Civils de Lyon, Lyon

8Université Claude Bernard Lyon 1, UFR Lyon Sud Charles Mérieux, Université de Lyon, Lyon

9Comité des Anti-Infectieux, Hospices Civils de Lyon, Lyon

*Corresponding author: A nne-Lise Bienvenu, 103 Grande Rue de la Croix-R ousse, 69004 Lyon. Email address: anne-lise.bienvenu@chu-lyon.fr (AL. Bienvenu) Mots clés : antifongiques, bon usage des antifongiques

Keywords: antifungals, antifungal stewardship

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2 Tr dvidc gTumeoT2id'TWoTrWduTivTildTgWe."TWpuekeue oaT

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fkWe.WP. Tvdic@T muuro@JJ222a. RevdWnp aRilkavdJWvvepms 0u agiMpegs 0u NO3=:sEPs77777758L5GC

T>Wpp oo gT

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T>Wpp oo gT

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g oTorhpeW.euhoTrmWdcWp luetl oaTfkWe.WP. Tvdic@TT muuro@JJ222a. RevdWnp aRilkavdJ .eJg pd uJ5745J*J,iJu 0u

T >Wpp oo gT frde.T

3<6T *hpd uT nKT 574GI gQWch.eidWueinTg T.WTtlW.euhT uTg T.Q vvepe np Tg oToienoT muuro@JJ222a. RevdWnp aRilkavdJ .eJg pd uJ574GJ8J57Jf:bb4G7>C4C*J,iJu 0u T >Wpp oo gT frde.TWording

Liposomal

amphotericin B

Inhaled

amphotericin B caspofungin fluconazole itraconazole micafungin posaconazole voriconazole

References

"Prophylaxis for invasive fungal infections in at-risk patients, especially in patients presenting with prolonged neutropenia (>10 days)"

Strong recommendation, high quality

evidence Sung AH, Marcella SW, Xie Y. An update to the cost- effectiveness of posaconazole vs fluconazole or itraconazole in the prevention of invasive fungal disease among neutropenic patients in the United States. J Med Econ 2015;18:341-8. Ebinger M, Schwarze CP, et al. Antifungal prophylaxis with posaconazole vs. fluconazole or itraconazole in pediatric patients with neutropenia. Eur J Clin Microbiol Infect Dis

2015;34:1189-200.

Duarte RF, López-Jiménez J, Cornely OA, Laverdiere M, Helfgott D, Haider S, et al. Phase 1b study of new posaconazole tablet for prevention of invasive fungal infections in high-risk patients with neutropenia. Antimicrob

Agents Chemother 2014;58:5758-65.

"Prophylaxis of invasive candidiasis in at-risk patients*, especially in intensive care units or in case of solid organ transplant" *Candida colonization, disease severity, exposure to broad- spectrum antibiotics, major and recent surgery especially at the abdominal level, necrotizing pancreatitis, dialysis, parenteral nutrition, corticosteroids, presence of a central venous catheter (Pappas PG, 2016)

Weak recommendation, moderate

quality evidence / ESCMID BI Pappas PG, Kauffman CA, Andes DR, Clancy CJ, Marr KA, Ostrosky-Zeichner L, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis 2016;62:e1-50. Cornely OA, Bassetti M, Calandra T, Garbino J, Kullberg BJ, Lortholary O, et al. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: non-neutropenic adult patients. Clin Microbiol Infect 2012;18 Suppl 7:19-37. Quality evidence: BI

Recommendations and quality evidence levels are from the Clinical Practice Guidelines of the Infectious Diseases Society of America (IDSA)

"Prophylaxis of invasive pulmonary aspergillosis in patients who underwent lung transplant or on a case-by-case basis in at-risk patients**, mainly in construction sites" **Refractory leukemia, solid tumors, solid organ transplants, corticosteroid treatment, COPD with progression of infiltrates despite antibiotic therapy, patients presenting with septic shock (Patterson TF, 2016)

Strong recommendation, moderate quality

evidence

Weak recommendation, low quality evidence

Strong recommendation, moderate quality

evidence

Weak recommendation, low quality evidence

Strong recommendation, moderate quality

evidence Patterson TF, Thompson GR 3rd, Denning DW, Fishman JA, Hadley S, Herbrecht R, et al. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis

2016;63:e1-e60.

Koval C. Echinocandins for antifungal prophylaxis in liver transplant recipients: Advance in the field or variation on a theme? Liver Transpl. 2016; 22:396-8. Xing T, Zhong L, Peng Z. Safety and effectiveness of antifungal prophylaxis in preventing fungal infection after liver transplantation: a meta-analysis of randomized clinical trials.

Int J Clin Pharmacol Ther 2016;54:564-71.

Chen YC, Huang TS, Wang YC, Cheng CH, Lee CF, Wu TJ, Chou HS, Chan KM, Lee WC, Soong RS. Effect of Prophylactic Antifungal Protocols on the Prognosis of Liver Transplantation: A Propensity Score Matching and Multistate Model Approach. Biomed Res Int 2016; 2016:6212503. Tableau 2. Thésaurus hors AMM des antifongiques en préemptif et empirique Table 2. Off-label thesaurus for preemptive and empirical antifungal therapies

Wording

Liposomal

amphotericin B

Inhaled

amphotericin B caspofungin fluconazole itraconazole micafungin posaconazole voriconazole

References

"Preemptive treatment of invasive fungal infections in asymptomatic or febrile at-risk patients, with positive biomarker, especially in patients presenting with prolonged neutropenia (>10 days) or in patients who underwent lung transplant" X X

Tan BH, Low JG, Chlebicka NL, Kurup A, Cheah FK, Lin RT, et al. Galactomannan-guided preemptive vs. empirical antifungals in the persistently febrile

neutropenic patient: a prospective randomized study. Int J Infect Dis 2011;15:e350-6. Cordonnier C, Pautas C, Maury S, Vekhoff A, Farhat H, Suarez F, et al. Empirical versus preemptive antifungal therapy for high-risk, febrile, neutropenic patients: a randomized, controlled trial. Clin Infect Dis 2009; 48:1042-51.

Maertens J, Theunissen K, Verhoef G,

Verschakelen J, Lagrou K, Verbeken E, et al.

Galactomannan and computed tomography-

based preemptive antifungal therapy in neutropenic patients at high risk for invasive fungal infection: a prospective feasibility study.

Clin Infect Dis 2005;41:1242-50.

Recommendations and quality evidence levels are from the Clinical Practice Guidelines of the Infectious Diseases Society of America (IDSA)

"Preemptive treatment of invasive candidiasis in asymptomatic or febrile at-risk patients*, with positive biomarker, especially in intensive care units

or in case of solid organ transplant" *Candida colonization, disease severity, exposure to broad-spectrum antibiotics, major and recent surgery especially at the abdominal level, necrotizing pancreatitis, dialysis, parenteral nutrition, corticosteroids, presence of a central venous catheter (Pappas PG, 2016)

Strong recommendation,

moderate quality evidence

Pappas PG, Kauffman CA, Andes DR, Clancy CJ, Marr KA, Ostrosky-Zeichner L, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis 2016;62:e1-50.

quotesdbs_dbs33.pdfusesText_39

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