Bayer has announced a Phase III CHICO study of Nifurtimox to treat children of all age groups with Chagas disease.
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Nifurtimox is a newly developed medicine by Bayer and is enlisted as one of the 'Essential Medicines' by the World Health Organisation for both adults and children.
Chagas is an infectious disease caused by single-cell parasites (trypanosoma), which spreads through the faeces / urine of kissing bugs or triatomines.
It can also be transmitted by infected blood transfusions, organ transplantation, or during pregnancy / birth from the infected mother to her unborn child.
The Chagas disease in children treated with nifurtimox (CHICO) study will be conducted as a prospective, historically controlled study to test the efficacy, safety and pharmacokinetics of Nifurtimox for the treatment of children with Chagas disease.
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By GlobalDataThe study will enrol 390 pediatric patients, including newborn babies.
Bayer pharmaceuticals division president and member of the board of management Dieter Weinand said: "As the manufacturer of Nifurtimox, we have a long-term commitment to the fight against this disease.
"Children are the most vulnerable patient group. Every child who can be treated is a step toward getting the disease under control."
The two-arm study will have a 30-day and 60-day treatment cycles against historical untreated control and intends to determine an appropriate, weight-adjusted dose of Nifurtimox for newborns and children using fast-disintegrating 30mg and 120mg tablets, which will be divided among weight-adjusted dosing in all age groups.
Image: Photomicrograph of Trypanosoma cruzi. Photo: courtesy of Dr. Myron G. Schultz.
