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A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients

Last updated on March 15, 2019

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Study Location
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female 2 to to enroll in this study only after a Pfizer sponsored pharmacokinetic study confirms
the proposed dosage corresponding to this age group is appropriate.

- Patients with confirmed Candida infection of the blood, body tissues, or the
esophagus.

- Patient's doctor feels voriconazole is an appropriate choice of therapy.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- A known allergy to voriconazole or to azole to antifungal drugs.

- Females who are pregnant, lactating (breast feeding) or planning a pregnancy during
the course of the study, or who are of childbearing potential and not using highly
effective method of birth control.

- A patient who is receiving treatment with a drug know to interfere with the heart's
electrical system (QTc prolongation).

- A patient who is receiving treatment with a drug that is not permitted to be used with
voriconazole.

- For primary therapy: a patient who has received more than 48 hours of antifungal
therapy for the current episode of Candida infection.

- A patient with significant underlying liver disease at the time of enrollment in the
study.

- A patient with significant renal disease (CrCl in the study.

- A patient with a high likelihood of death within 72 hours of study enrollment due to
factors unrelated to Candida infection.

NCT01092832
Pfizer
Terminated
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients

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