Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

NCT05881109 | Completed FDA Drug

• 1 other identifier: caspofungin-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Invasive Fungal Infections

Outcome Measures

Primary Outcomes (3)

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

  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) .

  1 day

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

  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

  1 day

• The PTAs of trough concentration

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

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

Interventions

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).

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The adolescents (12 - 17 years old) undergoing allo-HSCT and receiving CAS as prevention or treatment for IFIs

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Wuhan Children's Hospital

Wuhan, China

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 31, 2023
• Study Start: January 1, 2018
• Primary Completion: March 3, 2019
• Study Completion: March 3, 2019
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

CN (1)