Study Results
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Basic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2014-06-30
2015-11-30
Brief Summary
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Detailed Description
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The ATCF study is a prospective, multicenter, randomized, open-label, controlled phase II trial, performed in patients with cystic fibrosis with persistent Aspergillus positive cultures.
The primary outcome is to assess the efficacy of itraconazole and voriconazole on the course and outcome of the negativisation of the sputum cultures for Aspergillus on two consecutive cultures.
Secondary objectives include the effects of azole therapy on quality of life, FEV1, co-prescription of antibiotic and steroids, plasma concentrations of antifungal agents, speed of negativisation of sputum culture for Aspergillus, outcome of other diagnostic criteria (Aspergillus detection by PCR, precipiting antibodies, total and specific IgE, eosinophilia), and the safety profiles of the two products. Mycological failures, and impact of anti-fungal treatments on lung and systemic inflammation will also be assessed.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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itraconazole
* itraconazole 10 mg/mL oral solution
* patients \> 40 kg body weight : 200 mg morning and evening.
* patients \< 40 kg body weight : 100 mg morning and evening.
* dosage out of meal.
* Without a loading dose
Itraconazole/voriconazole
The two treatments will be administered orally for 6 months One doage of treatment permitted based on plasma levels will be performed after two weeks of treatment.
voriconazole
* voriconazole 40 mg/mL oral suspension :
* patients \> 40 kg body weight : 200 mg morning and evening.
* patients \< 40 kg body weight : 100 mg morning and evening.
* dosage out of meal.
* Without a loading dose
Itraconazole/voriconazole
The two treatments will be administered orally for 6 months One doage of treatment permitted based on plasma levels will be performed after two weeks of treatment.
Interventions
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Itraconazole/voriconazole
The two treatments will be administered orally for 6 months One doage of treatment permitted based on plasma levels will be performed after two weeks of treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* men or women,
* age equal greater to 12 years,
* presenting with a positive sputum culture for Aspergillus confirmed twice within 6 months before study entry and at initial visit,
* written informed consent.
Exclusion Criteria
* pregnant women or nursing mothers,
* absence of an effective method of contraception in women of child-bearing potential,
* patients with signs or symptoms of invasive aspergillosis,
* patients with signs or symptoms of aspergilloma,
* patients with an infection caused by Burkholderia complex Cepacia or to mycobacteria,
* lung transplant patients, registered on a transplantation waiting list or whose registration is imminent,
* patients who received systemic antifungal therapy for more than 5 days within 2 months prior to inclusion,
* patients currently enrolled in another clinical drug trial,
* ongoing treatment with medicinal products contraindicated with itraconazole and voriconazole or with major interactions which reduce azole concentrations,
* patients treated by medication known to prolong QT interval, or with known prolongation of QTc interval \> 450 msec in men and \> 470 msec in women,
* Inability to follow or to understand the study procedures.
12 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jean-Pierre Gangneux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service de parasito-mycologie - Rennes University Hospital
Locations
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CRCM Adulte et Pédiatrie - Hôpital Nord
Amiens, , France
CRCM adulte - Centre Robert Debré
Angers, , France
Pediatry - Centre Robert Debré
Angers, , France
Pediatric penumologic - Groupe hospitalier de Pellegrin
Bordeaux, , France
Pneumology pediatric - Hôpital Femme-Mère-Enfants
Bron, , France
CRCM - Pediatry - CHI Créteil
Créteil, , France
Service de Pneumologie-Immuno-Allergologie / Hôpital Calmette
Lille, , France
Hôpital Nord - Pneumology
Marseille, , France
Pneumologie Infantile - Hôpital des enfants
Nancy, , France
CRCM - Hôpital Sud
Rennes, , France
Pneumology - Hôpital Pontchaillou
Rennes, , France
CRCM Pédiatrique - Hôpital de Hautepierre
Strasbourg, , France
Pédiatrie - Pneumologie, Allergologie - Hôpital des enfants
Toulouse, , France
Pneumology - CH Bretagne-Atlantique
Vannes, , France
Manchester Adult Cystic Fibrosis Centre - University Hospital of South Manchester
Manchester, , United Kingdom
Countries
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References
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Gangneux JP, Godet C, Denning DW. Allergic diseases and fungal exposome: Prevention is better than cure. Allergy. 2022 Nov;77(11):3182-3184. doi: 10.1111/all.15436. No abstract available.
Guegan H, Prat E, Robert-Gangneux F, Gangneux JP. Azole Resistance in Aspergillus fumigatus: A Five-Year Follow Up Experience in a Tertiary Hospital With a Special Focus on Cystic Fibrosis. Front Cell Infect Microbiol. 2021 Feb 18;10:613774. doi: 10.3389/fcimb.2020.613774. eCollection 2020.
Guegan H, Poirier W, Ravenel K, Dion S, Delabarre A, Desvillechabrol D, Pinson X, Sergent O, Gallais I, Gangneux JP, Giraud S, Gastebois A. Deciphering the Role of PIG1 and DHN-Melanin in Scedosporium apiospermum Conidia. J Fungi (Basel). 2023 Jan 18;9(2):134. doi: 10.3390/jof9020134.
Other Identifiers
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2011-005799-41
Identifier Type: -
Identifier Source: org_study_id
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