Aspergillosis and Haematological Malignancy Clinical Trial
— OPTIFILOfficial title:
PET/CT Guided Antifungal Stewardship in Invasive Pulmonary Aspergillosis
| Verified date | October 2022 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
OPTIFIL is a pilot prospective multicenter study based over the hypothesis that the normalization of the functional imaging 18F-FDG-PET/CT during the Invasive pulmonary aspergillosis (IPA) could occur earlier than that of conventional imaging. This study evaluates the therapeutic response through a systematic 18F-FDG-PET/CT at week 6. The latter response will be correlated with the kinetics of selected biomarkers including antigens (galactomannan, β-D glucans), circulating Aspergillus DNA and anti-Aspergillus host response markers in addition to the conventional imaging tools obtained at weeks 6 and 12.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | May 2, 2022 |
| Est. primary completion date | May 2, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients =18 years-old - Patient with hematological malignancy - Proven or probable invasive pulmonary aspergillosis according to EORTC/MSG modified criteria - Inclusion = 4 days (= 5 days in case of week end) after IPA diagnosis - Possibility to perform 18F-FDG-PET/CT scanner within the 7 subsequent days following diagnosis - Informed consent form signed - Affiliation to French social insurance Exclusion Criteria: - Pregnancy or breastfeeding women - Life expectancy < 3 months - Fungal or mycobacterial lung co infection at time of IPA diagnosis - Haematological malignancy with lung location - Proven or probable mold infection in 6 previous months - Disseminated aspergillosis (lung and sinus aspergillosis can be included) |
| Country | Name | City | State |
|---|---|---|---|
| France | Department of Infectious Diseases and Tropical Medicine, Necker enfants malades hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Institut Pasteur, Paris France |
France,
Baxter CG, Marshall A, Roberts M, Felton TW, Denning DW. Peripheral neuropathy in patients on long-term triazole antifungal therapy. J Antimicrob Chemother. 2011 Sep;66(9):2136-9. doi: 10.1093/jac/dkr233. Epub 2011 Jun 17. — View Citation
Bitar D, Lortholary O, Le Strat Y, Nicolau J, Coignard B, Tattevin P, Che D, Dromer F. Population-based analysis of invasive fungal infections, France, 2001-2010. Emerg Infect Dis. 2014 Jul;20(7):1149-55. doi: 10.3201/eid2007.140087. — View Citation
Chamilos G, Macapinlac HA, Kontoyiannis DP. The use of 18F-fluorodeoxyglucose positron emission tomography for the diagnosis and management of invasive mould infections. Med Mycol. 2008 Feb;46(1):23-9. doi: 10.1080/13693780701639546. — View Citation
Epaulard O, Villier C, Ravaud P, Chosidow O, Blanche S, Mamzer-Bruneel MF, Thiébaut A, Leccia MT, Lortholary O. A multistep voriconazole-related phototoxic pathway may lead to skin carcinoma: results from a French nationwide study. Clin Infect Dis. 2013 Dec;57(12):e182-8. doi: 10.1093/cid/cit600. Epub 2013 Sep 17. — View Citation
Herbrecht R, Caillot D, Cordonnier C, Auvrignon A, Thiébaut A, Brethon B, Michallet M, Mahlaoui N, Bertrand Y, Preziosi P, Ruiz F, Gorin NC, Gangneux JP. Indications and outcomes of antifungal therapy in French patients with haematological conditions or recipients of haematopoietic stem cell transplantation. J Antimicrob Chemother. 2012 Nov;67(11):2731-8. doi: 10.1093/jac/dks266. Epub 2012 Jul 31. — View Citation
Hot A, Maunoury C, Poiree S, Lanternier F, Viard JP, Loulergue P, Coignard H, Bougnoux ME, Suarez F, Rubio MT, Mahlaoui N, Dupont B, Lecuit M, Faraggi M, Lortholary O. Diagnostic contribution of positron emission tomography with [18F]fluorodeoxyglucose for invasive fungal infections. Clin Microbiol Infect. 2011 Mar;17(3):409-17. doi: 10.1111/j.1469-0691.2010.03301.x. — View Citation
Lortholary O, Gangneux JP, Sitbon K, Lebeau B, de Monbrison F, Le Strat Y, Coignard B, Dromer F, Bretagne S; French Mycosis Study Group. Epidemiological trends in invasive aspergillosis in France: the SAIF network (2005-2007). Clin Microbiol Infect. 2011 Dec;17(12):1882-9. doi: 10.1111/j.1469-0691.2011.03548.x. Epub 2011 Jun 10. — View Citation
Marr KA, Schlamm HT, Herbrecht R, Rottinghaus ST, Bow EJ, Cornely OA, Heinz WJ, Jagannatha S, Koh LP, Kontoyiannis DP, Lee DG, Nucci M, Pappas PG, Slavin MA, Queiroz-Telles F, Selleslag D, Walsh TJ, Wingard JR, Maertens JA. Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med. 2015 Jan 20;162(2):81-9. doi: 10.7326/M13-2508. Erratum in: Ann Intern Med. 2015 Mar 17;162(6):463. Ann Intern Med. 2019 Feb 5;170(3):220. — View Citation
Moon WJ, Scheller EL, Suneja A, Livermore JA, Malani AN, Moudgal V, Kerr LE, Ferguson E, Vandenberg DM. Plasma fluoride level as a predictor of voriconazole-induced periostitis in patients with skeletal pain. Clin Infect Dis. 2014 Nov 1;59(9):1237-45. doi: 10.1093/cid/ciu513. Epub 2014 Jul 3. — View Citation
Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, Sobel J, Viscoli C, Walsh TJ, Maertens J, Patterson TF, Perfect JR, Dupont B, Wingard JR, Calandra T, Kauffman CA, Graybill JR, Baden LR, Pappas PG, Bennett JE, Kontoyiannis DP, Cordonnier C, Viviani MA, Bille J, Almyroudis NG, Wheat LJ, Graninger W, Bow EJ, Holland SM, Kullberg BJ, Dismukes WE, De Pauw BE. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clin Infect Dis. 2008 Sep 1;47(5):674-83. doi: 10.1086/590566. Review. — View Citation
Tedja R, El-Sherief A, Olbrych T, Gordon S. Multifocal periostitis as a complication of chronic use of voriconazole in a lung transplant recipient. Transpl Infect Dis. 2013 Aug;15(4):424-9. doi: 10.1111/tid.12088. Epub 2013 May 13. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response rate according to 18F-FDG-PET/CT (PET/CT response) | 6 weeks | ||
| Secondary | Response rate according to EORTC/MSG criteria (Segal response). | 6 weeks | ||
| Secondary | Response rate according to EORTC/MSG criteria (Segal response). | 12 weeks | ||
| Secondary | Response rate according to PET/CT | 12 weeks or at the end of treatment | ||
| Secondary | Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions | 6 weeks | ||
| Secondary | Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions | 12 weeks | ||
| Secondary | Number of patients for whom 18F-FDG-PET/CT has evidenced extra pulmonary attributable lesions in initial work-up | first day | ||
| Secondary | Patient mortality rate | overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies | 6 weeks | |
| Secondary | Patient mortality rate | overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies | 12 weeks | |
| Secondary | Patient mortality rate | overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies | 24 weeks | |
| Secondary | Patient mortality rate | overall mortality and relationship with Invasive Pulmonary Aspergillosis or Haematological Malignancies | 48 weeks |