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
NCT01092832
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | 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 ICMJE | 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 | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Candidiasis | |||
| Intervention ICMJE | Drug: voriconazole
Subjects 12 - <18 yrs (excluding subjects 12 - 14 yrs weighing <50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h. Subjects 2 - <12 yrs, and subjects 12 - 14 weighing <50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg). Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days. Other Name: Vfend | |||
| Study Arms ICMJE | Experimental: Active voriconazole
All subjects in this study will receive active voriconazole in an open-label fashion; there is no comparator in this study. Intervention: Drug: voriconazole | |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 23 | |||
| Original Estimated Enrollment ICMJE | 30 | |||
| Actual Study Completion Date ICMJE | June 2013 | |||
| Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 2 Years to 17 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | China, Czech Republic, Hong Kong, Hungary, Mexico, Philippines, Poland, Slovakia | |||
| Removed Location Countries | Argentina, Brazil, Bulgaria, Croatia, Germany, Malaysia, Romania, Singapore, Thailand | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01092832 | |||
| Other Study ID Numbers ICMJE | A1501085 2009-012848-16 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||