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Completed

NCT Number: NCT05881109

Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to fungal infections. The study aimed to establish a population pharmacokinetic (PPK) model and assess the dosing schemes of CAS in adolescents with allogeneic hematopoietic stem cell transplantation (allo-HSCT).

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Mycoses

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wuhan Children's Hospital

Wuhan, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The adolescents (12 - 17 years) underwent allo-HSCT
  • Use caspofungin for the prevention or treatment of fungal infections

Exclusion criteria

  • Intolerable to caspofungin
  • Participate into other clinical studies
  • There are conditions that researchers do not consider it appropriate to join the research.

Treatment and study plan

Caspogunfin

Drug

No specific interventions were administrated. Participants receive interventions as part of routine medical care, where CAS was infused intravenously over 60 min at a loading dose of 70 mg/m2 on day 1, followed by a maintenance dose of 50 mg/m2 (maximum: 70 mg daily).

Primary outcomes

  1. The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis

    Time frame: 1 day

    The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC90 (the lowest concentration of caspofungin at which 90% of the isolates were inhibited) (AUC24/MIC90) for C. albicans (0.06 mg/L), C. glabrata (450 mg/L), and C. parapsilosis (1185 mg/L) .

  2. The PTAs of AUC24/MIC for various species of Candida spp isolates

    Time frame: 1 day

    The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC (minimal inhibitory concentration) (AUC24/MIC) for various species of Candida spp isolates with a MIC range of 0.03 to 1.0 mg/L

  3. The PTAs of trough concentration

    Time frame: the trough concentration (24 hours after administration) at the steady state

    PTA of patients with CAS trough concentration ≥ 1 μg/mL

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents With Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 31, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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