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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 agents

safety 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

Page last updated: August 23, 2015

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