Phase 3
N=292
Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
Fungal Infection · Hematopoietic and Lymphoid Cell Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01503515 ↗Enrolled (actual)
292
Serious AEs
2.4%
Results posted
Jan 2021
Primary outcome: Primary: 42-day-cumulative Incidence of Proven or Probable Invasive Fungal Infections (IFI) — 1.4; 1.4 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Caspofungin Acetate (Drug); Fluconazole (Drug); Laboratory Biomarker Analysis (Other); Voriconazole (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 42-day-cumulative Incidence of Proven or Probable Invasive Fungal Infections (IFI) |
1.4; 1.4 | — |
Summary
This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.
Eligibility Criteria
Inclusion Criteria
- Age
- For centers that will use fluconazole as the antifungal comparator:
- Age >= 3 months and = 2 years and 16 years of age and Lansky for patients = = 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:
- 0.4 mg/dL (1 month to = 16 years of age)
- Total bilirubin = 0.5 index) within 30 days prior to time of enrollment (if performed) must have a full evaluation for invasive aspergillosis (including a negative chest computed tomography [CT] scan) during that time period to be eligible for enrollment
- Patients receiving treatment for an IFI are not eligible
- Patients with a history of echinocandin or azole hypersensitivity are not eligible
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
- Lactating females are not eligible unless they have agreed not to breastfeed their infants
Data sourced from ClinicalTrials.gov (NCT01503515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.