Clinical trial NCT01092832: 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
Official title: A Prospective, Open-label, Non-comparative Study To Assess The Safety, Tolerability And Efficacy Of Voriconazole For The Primary And Salvage Treatment Of Invasive Candidiasis, Candidemia, And Esophageal Candidiasis In Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Candidiasis
Keywords: Invasive Candidiasis Candidemia Esophageal Candidiasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Male or female 2 to \<18 years of age; Subjects 2 to \<12 years of age will be permitted 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:

* 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 \< 50 ml/min) at the time of enrollment in the study.
* A patient with a high likelihood of death within 72 hours of study enrollment due to factors unrelated to Candida infection.

Primary outcomes:
measure: Percentage of Participants With Adverse Events - Overall Summary
timeFrame: Baseline up to 1 month follow-up
Secondary outcomes:
measure: Percentage of Participants With a Global Response of Success at End of Treatment (EOT)
timeFrame: EOT (from 7 to 42 days of treatment)
measure: All-Cause Mortality - Number of Participant Deaths
timeFrame: Day 28 and 1 Month Follow-up
measure: Time to Death
timeFrame: Baseline up to 1 month follow-up
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital University of Medical Sciences
city: Brno
country: Czech Republic
facility: Fakultni nemocnice Brno - Klinika detske onkologie
city: Hong Kong
country: Hong Kong
facility: Department of Paediatrics and Adolescent Medicine
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin, N.T.
country: Hong Kong
facility: The Chinese University of Hong Kong, Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II. sz. Szemeszeti Klinika
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
city: Colonia Insurgentes Cuicuilco, Delegacion Coyoacan
country: Mexico
facility: Instituto Nacional de Pediatria
state: DF
city: Ermita,
country: Philippines
facility: Medical Research Laboratory Philippine General Hospital University of the Philippines
state: Manila
city: Manila
country: Philippines
facility: Rm. 112 ICHHD, National Institutes of Health-University of the Philippines Manila
city: Olsztyn
country: Poland
facility: Oddzial Pediatryczny I- Hematologiczno-Onkologiczny
city: Bratislava
country: Slovakia
facility: Detska fakultna nemocnica s poliklinikou Bratislava
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13. doi: 10.1097/INF.0000000000001339.