Clofazimine may be a safe and effective part of a surgical and multidrug regimen for treating children with Mycobacterium abscessus odontogenic osteomyelitis, according to a study presented at IDWeek 2017 held October 4-8 in San Diego, California.
Clofazimine (50 mg capsule) is commonly used for treatment of leprosy. However, during a healthcare-associated outbreak of M abscessus in children treated at a dental clinic in Anaheim, California, clofazimine received an investigational new drug application indication by the Food and Drug Administration to treat 27 children (mean age 5.8).
All 27 children had osteomyelitis of the jaw and received aggressive surgical debridement. Fourteen children had a positive acid-fast bacilli culture for M abscessus. Lung nodules were present in 16 children and granulomatous lymphadenitis requiring surgery in 10.
In addition to clofazimine, patients also received azithromycin, amikacin, and either imipenem or cefoxitin; beta-lactam therapy was stopped an average of 31 days after clofazimine was started. Clofazimine was given a mean of 105.6 days, with a mean dose of 1.1 mg/kg/day and because of the capsule size children were dosed an average of 3 days a week.
“All children showed evidence of jaw healing and resolution of lymphadenitis at the end of therapy, and 14 had resolved or improving lung nodules,” noted the investigators.
In addition, the investigators were able to lower the amikacin dosing when used in combination with clofazimine (from 23.4 mg/kg/day to 12.3 mg/kg/day 3 times per week), thus reducing the risk for adverse effects.
Most common side effects were mild and included anemia (74%), dry skin (63%), gastrointestinal disturbance (41%), and skin discoloration (22%). No child had a clinically significant change in corrected QT interval.
In an interview with Infectious Disease Advisor, Felice C. Adler-Shohet, MD, associate clinical professor of pediatrics at University of California, Irvine and director of outpatient services for infectious diseases at Children’s Hospital of Orange County in Orange, California, noted that “M abscessus can be a difficult organism to treat due to multidrug resistance. We are looking to older drugs used for other purposes in the past to treat some of these difficult infections.”
This is the largest reported case of children receiving clofazimine for reasons other than leprosy. One year follow-up showed that none of the patients had evidence of infection recurrence.
Adler-Shohet FC, Singh J, Nieves D, et al. Clofazimine for treatment of Mycobacterium abscessus infections in children. Presented at: IDWeek 2017; October 4-8, 2017; San Diego, California. Poster 2277.