ATCF (Azole Therapy in Cystic Fibrosis)
Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis; Aspergillus Infections
Intervention: Itraconazole/voriconazole (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Rennes University Hospital Official(s) and/or principal investigator(s): Jean-Pierre Gangneux, MD, PhD, Principal Investigator, Affiliation: Service de parasito-mycologie - Rennes University Hospital
Overall contact: Jean-Pierre Gangneux, MD, PhD, Phone: +33-223-234-490, Email: jean-pierre.gangneux@chu-rennes.fr
Summary
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.
Clinical Details
Official title: Efficacy of Itraconazole and of Voriconazole in Patients With Cystic Fibrosis and Presenting With Persistent Positive Sputums for Aspergillus.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in percentage of patients with a negativisation of sputum cultures in 2 successive samples
Secondary outcome: plasma concentrations of antifungal agentssafety of AFs including measurement of hepatic transaminases number of courses of steroids and antibiotics recording quality of life laboratory test indicators safety profiles of the antifungal agents mycological failures number of adverse events recording
Detailed description:
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 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.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Jean-Pierre Gangneux, MD, PhD, Phone: +33-223-234-490, Email: jean-pierre.gangneux@chu-rennes.fr
CRCM Adulte et Pédiatrie - Hôpital Nord, Amiens 80054, France; Recruiting Jean-Claude PAUTARD, MD, Principal Investigator
CRCM adulte - Centre Robert Debré, Angers 49033, France; Recruiting Thierry URBAN, MD, Principal Investigator
Pediatry - Centre Robert Debré, Angers 49033, France; Recruiting Françoise TROUSSIER, MD, Principal Investigator
Pediatric penumologic - Groupe hospitalier de Pellegrin, Bordeaux 33000, France; Recruiting Michael FAYON, MD, Principal Investigator
Pneumology pediatric - Hôpital Femme-Mère-Enfants, Bron 69500, France; Recruiting Stéphanie VRIELYNCK, MD, Principal Investigator
CRCM - Pediatry - CHI Créteil, Créteil 94000, France; Recruiting Natascha REMUS, MD, Principal Investigator
Service de Pneumologie-Immuno-Allergologie / Hôpital Calmette, Lille 59037, France; Recruiting Anne PREVOTAT, MD, Principal Investigator
Hôpital Nord - Pneumology, Marseille 13015, France; Recruiting Martine REYNAUD-GAUBERT, MD, PhD Martine REYNAUD-GAUBERT, MD, PhD, Principal Investigator
Pneumologie Infantile - Hôpital des enfants, Nancy 54577, France; Recruiting Jocelyne DERELLE, MD, Principal Investigator
CRCM - Hôpital Sud, Rennes 35000, France; Recruiting Eric DENEUVILLE, MD, Principal Investigator
Pneumology - Hôpital Pontchaillou, Rennes 35000, France; Recruiting Chantal BELLEGUIC, MD, Principal Investigator
CRCM Pédiatrique - Hôpital de Hautepierre, Strasbourg 67098, France; Recruiting Laurent Weiss, MD, Principal Investigator
Pédiatrie - Pneumologie, Allergologie - Hôpital des enfants, Toulouse 31059, France; Recruiting François BREMONT, MD, Principal Investigator
Pneumology - CH Bretagne-Atlantique, Vannes 56017, France; Recruiting Marie-Laure UFFREDI, MD, Principal Investigator
Manchester Adult Cystic Fibrosis Centre - University Hospital of South Manchester, Manchester M23 9LT, United Kingdom; Recruiting Alex HORSLEY, MD, Principal Investigator
Additional Information
Starting date: June 2014
Last updated: May 26, 2015
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