Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
PRNewswire - November 4, 2002
Cryptosporidium is a waterborne protozoan, causing diarrhea that normally lasts up to 2 to 3 weeks. The disease can become chronic in persons with weak immune systems such as those undergoing treatment for cancer and persons with AIDS. In persons with AIDS, Cryptosporidium infection is associated with a reduction in life expectancy. In developing countries, Cryptosporidium infection has also been shown to cause malnutrition, impaired growth and cognitive development and death, particularly in children.
Cryptosporidium gained notoriety in the United States following an outbreak due to contaminated water supplies in Milwaukee, Wisconsin.
Recently, Cryptosporidium was included in the list of potential bio-terror agents compiled by the United States Centers for Disease Control and Prevention (CDC).
There is presently no FDA-approved treatment for cryptosporidiosis. Other double-blind placebo-controlled studies, one reported in The Journal of Infectious Diseases in July, 2001, and another in the British journal, Transactions of the Royal Society of Tropical Medicine and Hygiene in 1998, have shown that nitazoxanide reduces the duration of diarrhea caused by Cryptosporidium infection in immunocompetent adults and children, and in adults with AIDS.
"The findings of our study are important because they show that a short, 3-day intervention with nitazoxanide can significantly improve the outcome of cryptosporidial infection in these children," said Dr. Paul Kelly of the University of London, one of the study's authors. Nitazoxanide is an investigational new drug in the United States.
Clinical Trial Finds Reduction in Morbidity and Mortality in Malnourished Children
The study was conducted with 50 HIV-positive and 50 HIV-negative children with cryptosporidial diarrhea who were hospitalized at the University Teaching Hospital, Lusaka, Zambia, between November, 2000, and July, 2001. Most of the children were younger than 3 years and malnourished. The children were randomly assigned nitazoxanide (100 mg twice daily orally for 3 days) or placebo.
In the HIV-negative group, 18% of the children treated with a placebo died within the 7 days following enrollment in the study, while there were no deaths among the children treated with the nitazoxanide suspension.
The separate group of children with HIV were enrolled in the study to determine whether they would benefit from treatment with nitazoxanide and if the outcomes would differ from those observed in non-HIV infected children.
Children with HIV did not respond to a 3-day course of nitazoxanide, but 87% responded clinically after treatment with a second, 3-day course of treatment. Additional studies are underway to evaluate the efficacy of longer courses of nitazoxanide in treating children with AIDS.
About Romark Laboratories
Romark Laboratories is a privately owned, research-based pharmaceutical company based in Tampa, Fla., dedicated to the discovery and development of innovative new pharmaceutical products for treating infectious diseases and cancer. Learn more by visiting http://www.romarklabs.com.
About nitazoxanide
Nitazoxanide is a new broad-spectrum antimicrobial medication with activity against protozoa, anaerobic and microaerophylic bacteria and helminths. It targets an essential enzyme, PFOR (pyruvate ferredoxin oxidoreductase), in anaerobic and microaerophylic organisms, disrupting energy metabolism. This mechanism provides for a broad spectrum of activity against organisms that use anaerobic energy metabolism pathways while avoiding toxic mechanisms associated with drugs historically used to treat protozoan infections. Nitazoxanide is marketed throughout much of Latin America and is an investigational new drug in the United States for treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia.
SOURCE Romark Laboratories, L.C.
Web Site: http://www.romarklabs.com
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