Study of posaconazole blood levels comparing two different oral presentations, a syrup and a solid tablet, in patients with leukaemia at a high risk of fungal infections

• Conditions: Invasive Mycoses; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003940-38-ES
• Lead Sponsor: Fundación Investigación Biomédica Puerta de Hierro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adult patiens with an indication for antifungal prophylaxis with posaconazole for prolonged severe neutropenia after intensive chemotherapy for acute myeloid leukemia or myelodysplastic syndromes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Excluded are patients with a history of invasive mycosis, recipients of allogeneic transplantation with or without graft-versus-host disease, with abnormal liver or renal function, prolonged QTc, ECOG >2, pregnant women, or those with some concomitant or previous treatments.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified