December 30, 2013 – Daniel Benjamin, MD, MPH, PhD, and other researchers analyzed the findings of two phase I trials of the drug in children and infants.
The antifungal drug micafungin is safe for children with Candida infections, according to a new study led by the DCRI’s Daniel Benjamin, MD, MPH, PhD.
The study appears in a recent issue of The Pediatric Infectious Disease Journal.
Invasive candidiasis is a fungal infection that can occur when Candida yeasts enter the bloodstream. Although relatively uncommon among the general population, it is prevalent among hospitalized patients in the United States, including low–birth-weight and immunocompromised children. Although clinicians have successfully treated these infections with amphotericin B and fluconazole, amphotericin B’s side effects and the emergence of fluconazole-resistant strains of Candida have prompted a search for new therapies.
In this study, Benjamin and colleagues from Illinois and California sought to determine whether micafungin is an effective alternative to amphotericin B and fluconazole. Earlier studies have suggested that micafungin is safe for children, including those with life-threatening illnesses. To better evaluate the safety and effectiveness of the drug, the researchers analyzed patient data from two phase I, prospective, multicenter trials. The first study comprised 78 infants and adolescents aged 2–16 years. Children were grouped by weight at baseline to receive either 3 mg/kg or 4.5 mg/kg of micafungin, with a maximum daily dose of 150 mg. The population of the second study comprised 9 toddlers aged 4 months to less than 2 years. In this trial, all children received 4.5 mg/kg micafungin, with a maximum daily dose of 150 mg.
Most of the children in the first study (80 percent) experienced at least one adverse event, whereas all of the children in the second study experienced one or more adverse events. The most common adverse events were pyrexia, hypokalemia, and vomiting. Adverse events due to micafungin were less common, with only 28 children in the first study and 1 in the second study experiencing an adverse event related to the drug. The most common adverse events considered to be related to micafungin treatment were infusion-associated symptoms such as hypotension, hypertension and cyanosis, pyrexia, and hypomagnesemia. Four children in the first study died; three died during the study period and one after the end of the follow-up period. The micafungin pharmacokinetic profile was similar to that seen in other studies conducted in children, but different than that observed in adults.
Because micafungin-related adverse events were relatively uncommon and generally did not lead to discontinuation of treatment, the researchers concluded that once-daily 3 mg/kg and 4.5 mg/kg doses of micafungin are well tolerated in children and adolescents with proven, probable, or suspected Candida infection. Furthermore, the pharmacokinetic information obtained in these studies can be used to better calibrate the necessary dosage of the medication.