Clinical trial · Interventional
Anidulafungin in Treating Immunocompromised Children With Neutropenia
Phase I-II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Neutropenia
NCT00068471CI-TRIAL-00010797completedPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Anidulafungin may be effective in preventing fungal infections in immunocompromised children who have neutropenia. PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how well it works in preventing fungal infections in immunocompromised children with neutropenia caused by chemotherapy or aplastic anemia.
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 |
|---|---|---|---|
| Infection | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anidulafungin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Neutropenia due to cytotoxic chemotherapy or aplastic anemia * Duration expected to be 10 days * Absolute neutrophil count less than 500/mm\^3 OR less than 1,000/mm\^3 and expected to fall below 500/mm\^3 within 72 hours * No deeply invasive fungal infection confirmed prior to study entry PATIENT CHARACTERISTICS: Age * 2 to 17 Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * AST or ALT no greater than 5 times upper limit of normal (ULN) * Bilirubin no greater than 2.5 times ULN Renal * Creatinine clearance at least 30 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for at least 30 days after study participation * No prior anaphylaxis attributed to the echinocandin class of antifungals * No other concurrent medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since prior investigational drugs * No prior participation in this clinical trial * No prior anidulafungin * No other concurrent investigational drugs * No other concurrent systemic antifungal agents (e.g., amphotericin, systemic azoles, or triazole antifungal agents) * Concurrent oral, nonabsorbable azoles and topical antifungal agents (e.g., nystatin and/or azole formulations) allowed * Concurrent broad-spectrum antibiotics allowed
References
Publications (0)
Data not yet available
No reference posted for this study.