Cystic Fibrosis Clinical Trial
— ATCFOfficial title:
Efficacy of Itraconazole and of Voriconazole in Patients With Cystic Fibrosis and Presenting With Persistent Positive Sputums for Aspergillus.
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study aims to assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for Aspergillus.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - Patient with cystic fibrosis, - 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: - patients with a contraindication to one of the antifungal agents evaluated, - 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. |
Country | Name | City | State |
---|---|---|---|
France | 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 | |
United Kingdom | Manchester Adult Cystic Fibrosis Centre - University Hospital of South Manchester | Manchester |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France, United Kingdom,
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. — View Citation
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) — View Citation
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/ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in percentage of patients with a negativisation of sputum cultures in 2 successive samples | The primary evaluation criterion is the percentage of patients with a negativisation of sputum cultures in 2 successive samples, according to a standardised technique | Change from baseline in persentage of patients with a negativisation of sputum cultures at 4, 8, 16, 24 weeks after initiation of therapy | |
Secondary | plasma concentrations of antifungal agents | measurement of plasma concentrations of antifungal agents and testing at 4 weeks in case of dose adjustment. | at 2 weeks after initiation of therapy | |
Secondary | safety of AFs including measurement of hepatic transaminases | safety of AFs including measurement of hepatic transaminases | at 2 weeks after initiation of therapy | |
Secondary | number of courses of steroids and antibiotics recording | number of courses of steroids and antibiotics | at 2 weeks after initiation of therapy | |
Secondary | quality of life | quality of life self-questionnaire scores, dyspnoea scale scores, 6 minute walking test, FEV1 value, and number of courses of steroids and antibiotics | at 4, 8, 16 and 24 weeks after initiation of therapy | |
Secondary | laboratory test indicators | course of different laboratory test indicators (sputum culture and PCR, IgG, total and specific IgE, eosinophilia) | at 4, 8, 16 and 24 weeks after initiation of therapy | |
Secondary | safety profiles of the antifungal agents | safety profiles of the antifungal agents : impact of anti-fungal treatments on lung and systemic inflammation | at 4, 8, 16 and 24 weeks after initiation of therapy | |
Secondary | mycological failures | analysis of mycological failures (defined as persistence of a positive culture) by a study over time of the course and outcome of fungal biodiversity of isolates (sequential study of chemosensitivity to different antifungal agents and molecular typing) | after 1 month | |
Secondary | number of adverse events recording | number of adverse events recording | at 2 weeks after initiation of therapy |
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