N/A
N=323
Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and Neutropenia
Febrile Neutropenia
Bottom Line
View on ClinicalTrials.gov: NCT00723073 ↗Enrolled (actual)
323
Serious AEs
1.6%
Results posted
Aug 2010
Primary outcome: Primary: Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN) — 122; 141; 27; 33 participants — p=0.96
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN) |
122; 141; 27; 33 | 0.96 |
| PRIMARY Successful Treatment of Any Baseline Invasive Fungal Disease (IFD) |
146; 168; 2; 4; 1; 2 | >0.99 |
| PRIMARY Mortality at Hospital Discharge |
137; 161; 12; 13 | >0.99 |
| PRIMARY Absence of Any Breakthrough Invasive Fungal Disease (IFD) |
133; 153; 16; 21 | 0.48 |
| PRIMARY Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy |
146; 172; 3; 2 | 0.57 |
| SECONDARY Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN) |
10; 9 | 0.66 |
| SECONDARY Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy |
110; 132; 14; 15; 10; 9 | — |
| SECONDARY Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation |
146; 172; 2; 1; 0; 1 | — |
| SECONDARY Duration of Hospitization |
29; 28 | 0.22 |
| SECONDARY Duration of Neutropenia |
20; 17 | 0.11 |
Summary
Invasive fungal infections are an important cause of morbidity and mortality in patients with neutropenia who are receiving chemotherapy for cancer. Early diagnosis of these infections is difficult and fever may be the only sign. A delay in treatment while a diagnosis is pursued may lead to increased morbidity and mortality. There are now several echinocandins available with similar in vitro spectrum of activity. Caspofungin is the only echinocandin Food and Drug Administration (FDA) approved for empiric antifungal therapy in febrile neutropenia. Although all echinocandin antifungal agents have similar spectrum of activity, there are limited data on the use of micafungin in patients with persistent fever and neutropenia (FN). In November 2006 the Pharmacy and Therapeutics Committee at Brigham & Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) switched from caspofungin to micafungin as our formulary echinocandin. Given the limited clinical data on the use of micafungin as empiric antifungal therapy in patients with FN, we sought to evaluate the safety and effectiveness of micafungin, compared with caspofungin, for this indication using a sequential cohort analysis of patients treated before and after the formulary change at Brigham and Women's Hospital.
Eligibility Criteria
Inclusion Criteria
- All patients admitted to BWH/DFCI who received at least 2 doses of caspofungin with an Absolute Neutrophil Count (ANC) 500 at when either micafungin or caspofungin was started
- Patients who received another antifungal agent for persistent febrile neutropenia, e.g., voriconazole, amphotericin B liposome, posaconazole, etc... Before they received an echinocandin (caspofungin or micafungin) will be excluded
Data sourced from ClinicalTrials.gov (NCT00723073). 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.