Clinical trial · Interventional
Pharmacokinetics of Anidulafungin (Ecalta ®) Intravenous Given to Patients at High Risk for Developing Invasive Fungal Disease
Pharmacokinetics of Anidulafungin Given Intravenously as Antifungal Prophylaxis to Recipients of an Allogeneic Haematopoietic Stem Cell Transplant Following Myeloablative Chemotherapy or Patients Receiving Intensive Chemotherapy for AML-MDS
- 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)
The purpose of this study is to study the pharmacokinetics of anidulafungin (Ecalta ®) given intravenously as antifungal prophylaxis to recipients of an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or patients receiving intensive chemotherapy for AML-MDS who are at high risk for developing invasive fungal disease.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anidulafungin 200 mg q48h | Drug | — | UNRESOLVED |
| anidulafungin 300 mg q72h | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- group A
- description
- Day 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages)
- interventionNames
- Drug: anidulafungin 200 mg q48h
- type
- EXPERIMENTAL
- label
- group B
- description
- Day 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages)
- interventionNames
- Drug: anidulafungin 300 mg q72h
Primary outcomes (1)
- measure
- pharmacokinetics
- timeFrame
- two weeks per subject
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Patient receives an allogeneic haematopoietic stem cell transplant following myeloablative chemotherapy or receives intensive chemotherapy for AML-MDS * Subject is at least 18 and not older than 65 years of age on the day of the first dosing * Has no signs or symptoms of invasive fungal disease * If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant * Has an ALAT, ALAT, alkaline phosphatase \< 5 times the upper limit of normal and a bilirubin level \< 3 times the upper limit of normal * Is not known to be hypersensitive to echinocandin antifungal agents * Is managed with a quadruple central venous catheter (Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International) * Subject is able and willing to sign the Informed Consent before screening evaluations Exclusion Criteria: * Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation * Known of Positive HIV test or hepatitis B or C test in history * History of QT time prolongation * History of or current abuse of drugs, alcohol or solvents * Inability to understand the nature of the trial and the procedures required * Has not previously participated in this trial
References
Publications (1)
- RESULTBruggemann RJ, Van Der Velden WJ, Knibbe CA, Colbers A, Hol S, Burger DM, Donnelly JP, Blijlevens NM. A rationale for reduced-frequency dosing of anidulafungin for antifungal prophylaxis in immunocompromised patients. J Antimicrob Chemother. 2015 Apr;70(4):1166-74. doi: 10.1093/jac/dku477. Epub 2014 Dec 3. PMID 25473029