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NIH launches delamanid trial for MDR-TB prevention

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Anthony S. Fauci

The National Institute of Allergy and Infectious Diseases, part of the NIH, has launched a trial investigating the safety and efficacy of delamanid for the prevention of multidrug-resistant tuberculosis, or MDR-TB, the NIH announced.

The phase 3 clinical trial, called Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients, or PHOENIx MDR-TB, will compare the more recently developed drug delamanid — one of the first agents available specifically to treat patients with MDR-TB and the first to exist in a formulation suitable for children — with the commonly used TB drug isoniazid in the prevention of active MDR-TB disease in children, adolescents and adults at high risk who are exposed to adult household members with MDR-TB, according to the NIH. The study researchers define high-risk participants as those with latent TB infection, those with immune systems suppressed by HIV or other factors, or those aged 5 years or younger who therefore have weaker immune systems.

“It's important to understand that MDR-TB is a growing problem, and we really have difficulty in treating it, so one of the important issues we'd like to do is to see if we can prevent the development of MDR-TB in individuals at high risk,” Anthony S. Fauci, MD, director of NIAID, told Infectious Diseases in Children. “This study is introducing into the prevention arena a drug that is relatively new and that has been successfully used in the treatment of MDR-TB.”

The trial will take place in at least 12 countries, including Botswana, Brazil, Haiti, India, Kenya, Peru, the Philippines, South Africa, Tanzania, Thailand, Uganda and Zimbabwe. The researchers will enroll approximately 5,610 participants, including 2,158 adults aged 18 years and older who are receiving treatment for active MDR-TB through their country’s national TB treatment program and 3,452 members of the active MDR-TB participants’ households who are at high risk for developing the disease. The household contacts will be randomly assigned either oral delamanid daily for 26 weeks or oral isoniazid plus vitamin B 6 daily for the same amount of time.

The researchers hypothesize that prophylactic treatment with delamanid will be more effective than isoniazid at reducing the likelihood that household contacts of patients with MDR-TB will develop active TB disease.

“We urgently need to halt the spread of MDR-TB,” study lead Gavin Churchyard, MBBCh, MMed, PhD, CEO of the Aurum Institute for Health Research, Johannesburg, South Africa, said in the release. “Preventing latent MDR-TB from progressing to active disease protects the health of the individual while reducing the transmission of drug-resistant Mycobacterium tuberculosis.” – by Joe Gramigna

Disclosures: Fauci is employed by NIAID. Infectious Diseases in Children was unable to confirm relevant financial disclosures for Churchyard at time of publication.