Drug appears safe in children with C. difficile infections

Early test suggests adult med may work in kids with diarrheal disease

PHILADELPHIA — The antibiotic fidaxomicin, which is prescribed for adults for Clostridium difficile infections, seems safe for children to take, a study shows.

C. difficile, or C. diff, is a bacterium that releases a toxin that attacks the lining of the intestines, causing colitis and severe diarrhea that can be lethal. Doctors have limited drug options against C. diff. When fidaxomicin was cleared by regulators in 2011 for use in adults, it became the first new drug to tackle C. diff in more than two decades. It is marketed as Dificid by Cubist Pharmaceuticals in Lexington, Mass.

But it hadn’t been tested in children. Cubist researcher Pamela Sears teamed with scientists at hospitals to treat 38 children ranging in age from 11 months to 17 years who had C. diff. Nine of the children also had cancer. The patients received the drug for 10 days either as pills or in an oral suspension.

By the last day of treatment, 35 of the 38 patients had shown a complete response, meaning they had had no diarrhea for several days. Ten of these patients experienced diarrhea at some point later.

The drug caused mild-to-moderate side effects such as fever and vomiting, said Steven Gilman, Cubist’s chief scientific officer, on October 11 at ID Week, an annual meeting of the Infectious Diseases Society of America and related health care associations. “This is a good start [with] encouraging data,” he said. The company plans further tests.

Editor’s note: This story was updated on October 17, 2014, to correct the location of Cubist Pharmaceuticals.

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