Study evaluating the pharmacokinetics, safety and tolerability of Voriconazole in children aged 2-12 years who require treatment of systemic fungal infectio

• Conditions: Systemic Fungal Infection; MedDRA version: 18.0Level: LLTClassification code 10042941Term: Systemic fungal infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004183-38-Outside-EU/EEA
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-21
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Children (both male and female) aged from 2 to <12 years who required treatment for the prevention of systemic fungal infection.
2. Children who were expected to develop neutropenia lasting for more than 10 days following chemotherapy for one of the following conditions:
a. leukaemia
b. lymphoma
c. aplastic anaemia
d. as the preparative regimen for bone marrow transplantation
3. Subjects who were anticipated to live for more than three months.
4. Females of childbearing potential must have had a negative pregnancy test at entry.
Are the trial subjects under 18? yes
Number of subjects for this age range: 28
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who were receiving and could not discontinue the following drugs at least 24 hours prior to study start:
Terfenadine and cisapride (due to the possibility of QTc prolongation with these drugs)
Omeprazole (an inhibitor of CYP2C19) which is known to increase plasma voriconazole levels.
Subjects who had received the following drugs within 14 days prior to study entry:
Rifampicin, rifabutin, carbamazepine, phenytoin, nevirapine and barbiturates as these are inducers of hepatic enzymes and may result in undetectable levels of voriconazole.
2. Subjects who had received astemizole within the previous 60 days.
3. Subjects with any clinically significant abnormality following review of screening laboratory data other than that associated with their underlying disease. Aspartate transaminase (AST) and alanine transaminase (ALT) had to be <5 * upper limit of normal.
4. Subjects who were taking or were likely to receive any investigational drug except: those used for the treatment of child’s cancer, antiretroviral agents and drugs used for treatment of any acquired immune deficiency syndrome (AIDS) defining opportunistic infections, all of which were allowed.
5. Subjects with a history of hypersensitivity to or severe intolerance of azole antifungal agents.
6. Subjects who had already been entered into this protocol once.
7. Subjects with moderate and severe renal impairment (
i.e. calculated creatinine clearance <30 millilitre per minute (ml/min). If creatinine clearance was reduced to <30 ml/min at any time during the study, the subject had to be discontinued from the study. Creatinine clearance was calculated using the equation

Creatinine Clearance (ml/min) = 0.55*height (cm)/serum creatinine (mg/dL)

8. Subjects with a medical history or current evidence of cardiac arrhythmia.
9 Any other condition which, in the opinion of the investigator, would make the subject unsuitable for enrollment.

Study & Design

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