Clinical trial · Interventional
A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area
A New Dosing Regimen for Posaconazole Prophylaxis in Children Based in Body Surface Area
NCT02372357CI-TRIAL-00016963completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Procedure | — | UNRESOLVED |
| Posaconazole prophylaxis 120 mg/m² tid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Posaconazole 120mg/m² tid
- description
- Pediatric patients admitted to receive chemotherapy or hematopoietic stem cell transplantation for the treatment of a hematological malignancy are receiving Posaconazole prophylaxis 120 mg/m² tid. At steady state, blood sampling will be performed: 9 blood samples will be taken during 1 dosing interval to evaluate the pharmacokinetics of posaconazole.
- interventionNames
- Drug: Posaconazole prophylaxis 120 mg/m² tid
- Procedure: Blood sampling
Primary outcomes (1)
- measure
- pharmacokinetic parameters of posaconazole
- timeFrame
- One day at steady state posaconazole treatment
- description
- 9 blood samples are taken during one day at steady state posaconazole plasma concentrations. The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Cmax, Cmin, Tmax, Area Under the Curve during 1 dosing interval and over 24 hours, Clearance, Distribution volume, Halflife.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: * 2-13 years of age * hematological malignancy * need for antifungal prophylaxis because of neutropenia caused by chemotherapy and/or hematopoietic stem cell transplantation. Exclusion Criteria: * \<2 years of age * \> 13 years of age
References
Publications (0)
Data not yet available
No reference posted for this study.