Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02227797
Other study ID # 2013LS126
Secondary ID MT2013-37R
Status Completed
Phase Phase 1
First received
Last updated
Start date January 19, 2015
Est. completion date March 1, 2019

Study information

Verified date April 2019
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date March 1, 2019
Est. primary completion date September 8, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent)

- Age = 21 years

- Adequate organ function within 14 days of enrollment, i.e. Creatinine: < 1.5 x ULN and Hepatic: ALT, AST and total bilirubin < 3 x ULN

- Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation

Exclusion Criteria:

- Has received voriconazole within 5 days prior to starting study therapy

- History of hypersensitivity or severe intolerance to azoles

- History, or current evidence, of cardiac arrhythmias defined as QTc = 480 mm/sec

- Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.

- Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates.

- Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism

- Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Voriconazole
6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients

Locations

Country Name City State
United States University of Minnesota Medical Center, Fairview Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups Seven days after starting voriconazole
Secondary Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups After starting voriconazole: Day 5, between Days 12-15, between Days 19-22
Secondary Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42
Secondary Incidence of fungal infection 6-month period after transplant
See also
  Status Clinical Trial Phase
Completed NCT03641131 - Ampholipad Real-World Data in Taiwan
Not yet recruiting NCT03292224 - Systemic Fungal Infections in ICU Patients N/A
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT00936117 - Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia Phase 2
Completed NCT00740389 - TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects. Phase 1
Completed NCT03857399 - Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin Phase 2
Not yet recruiting NCT04215458 - Microbiota in Skin and Mucosa of Patients With Inflammatory Skin Diseases N/A
Completed NCT03667690 - Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis Phase 3
Completed NCT02957929 - Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally Phase 1
Completed NCT01419678 - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients N/A
Recruiting NCT00333645 - Prophylaxis With Caspofungin in High-Risk Liver Transplantation Phase 2
Not yet recruiting NCT03650439 - Fungal Infections in Patients With Hematological Malignancies
Completed NCT01303549 - Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients Phase 4
Withdrawn NCT00430469 - Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients Phase 1/Phase 2
Completed NCT00811642 - Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551) Phase 3
Terminated NCT00386997 - ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia Phase 4
Completed NCT00514358 - Fluconazole Pharmacokinetics in Infants Phase 1
Completed NCT04166669 - A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 Phase 1
Recruiting NCT05150327 - Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Completed NCT02387983 - Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117) Phase 1