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Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized
Flavio Queiroz-Telles1, Eitan Berezin, Guy Leverger
1Hosp de Clinica, Curitiba, Brazil.
Background:
Invasive candidiasis is increasingly prevalent in premature infants and seriously ill children, and pediatric data on available antifungal therapies are lacking.
Methods:
We conducted a pediatric substudy as part of a double-blind, randomized, multinational trial to compare micafungin (2 mg/kg) with liposomal amphotericin B (3 mg/kg) as first-line treatment of invasive candidiasis. Treatment success was defined as clinical and mycologic response at the end of therapy. Statistical analyses were descriptive, as the sample size meant that the study was not powered for hypothesis testing.
Results:
One hundred six patients were included in the intent-to-treat population; and 98 patients-48 patients in the micafungin group and 50 patients in the liposomal amphotericin B group-in the modified intent-to-treat population. Baseline characteristics were balanced between treatment groups. Overall, 57 patients were <2 years old including 19 patients who were premature at birth; and 41 patients were 2 to <16 years old. Most patients (91/98, 92.9%) had candidemia, and 7/98 (7.1%) patients had other forms of invasive candidiasis. Treatment success was observed for 35/48 (72.9%) patients treated with micafungin and 38/50 (76.0%) patients treated with liposomal amphotericin B. The difference in proportions adjusted for neutropenic status was -2.4% [95% CI: (-20.1 to 15.3)]. Efficacy findings were consistent, independent of the neutropenic status, the age of the patient, and whether the patient was premature at birth. Both treatments were well tolerated, but with a lower incidence of adverse events that led to discontinuation in the micafungin group (2/52, 3.8%) compared with the liposomal amphotericin B group (9/54, 16.7%) (P = 0.05, Fisher exact test).
Conclusions:
Micafungin seems to be similarly effective and as safe as liposomal amphotericin B for the treatment of invasive candidiasis in pediatric patients. (ClinicalTrials.gov number, NCT00106288).
Insights
Micafungin and liposomal amphotericin B showed similar effectiveness for treating invasive candidiasis in children. Micafungin had fewer adverse events leading to treatment discontinuation, suggesting comparable safety in pediatric patients.
Area of Science:
- Pediatric Infectious Diseases
- Mycology
- Clinical Pharmacology
Background:
- Invasive candidiasis presents a growing challenge in critically ill and premature infants.
- Limited pediatric data exists for current antifungal therapies, necessitating further research.
Purpose of the Study:
- To compare the efficacy and safety of micafungin versus liposomal amphotericin B as first-line treatment for invasive candidiasis in pediatric patients.
- To evaluate treatment success based on clinical and mycologic response at the end of therapy.
Main Methods:
- A pediatric substudy within a double-blind, randomized, multinational trial.
- Comparison of micafungin (2 mg/kg) and liposomal amphotericin B (3 mg/kg) in pediatric patients.
- Descriptive statistical analyses due to limited sample size for hypothesis testing.
Main Results:
- Treatment success rates were similar: 72.9% for micafungin (35/48) and 76.0% for liposomal amphotericin B (38/50).
- Efficacy remained consistent across different age groups, neutropenic status, and prematurity.
- Micafungin demonstrated a lower incidence of adverse events leading to discontinuation (3.8% vs. 16.7%, P=0.05).
Conclusions:
- Micafungin appears to be as effective and safe as liposomal amphotericin B for invasive candidiasis in pediatric populations.
- The findings support micafungin as a viable therapeutic option for pediatric invasive candidiasis.
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