Clinical Trials Logo
  1. Home
  2. Invasive Fungal Infections
  3. NCT00734500

Anidulafungin PK in Infants and Toddlers

Invasive Fungal Infections Clinical Trial

Official title:
Anidulafungin PK in Infants and Toddlers

Clinical Trial Summary

This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00734500
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date January 2008
Completion date June 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT05749380 - Pharmacokinetics and Safety of AmBisome and DKF-5122 Phase 1
Not yet recruiting NCT02527928 - Cost-Effectiveness of Amphotericin B N/A
Completed NCT02851680 - Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia. N/A
Completed NCT03572049 - Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole Phase 2/Phase 3
Suspended NCT05534529 - Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age Phase 1
Completed NCT04024995 - Revision of Antifungal Strategies Definitions for Invasive Fungal Infections in Hematological Malignancies
Completed NCT00745992 - Voriconazole Blood Level and Liver Metabolizing Enzyme in Taiwanese Patients
Completed NCT06413056 - Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection Phase 4
Recruiting NCT05130723 - Pharmacokinetics of Fluconazole in Children (2-18 Years)
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Completed NCT04122560 - Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration Phase 4
Completed NCT03262584 - Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
Completed NCT02678598 - A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections N/A
Completed NCT05491733 - A Bioequivalence Study of APX001 High-load and Low-load Tablets Phase 1
Not yet recruiting NCT06220370 - PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.
Completed NCT04777058 - Pharmacokinetics of Isavuconazole in Patients in the Intensive Care Unit
Recruiting NCT03583164 - Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options Phase 2
Completed NCT03174457 - Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
Completed NCT00750737 - Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) Phase 3
Not yet recruiting NCT06346951 - Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS)