Key points
- The Food and Drug Administration (FDA) approved nitazoxanide to treat diarrhea caused by Cryptosporidium in people with healthy immune systems.
- The effectiveness of nitazoxanide to treat Cryptosporidium in people with weakened immune systems is unclear.
Treatment options
In 2002, the U.S. Food and Drug Administration (FDA) licensed nitazoxanide (Alinia®, Romark Laboratories, Tampa, FL, USA) for the treatment of cryptosporidiosis in children with healthy immune systems aged 1–11 years. In 2004, nitazoxanide was also licensed for people with healthy immune systems aged 12 years and older. It can now be prescribed for all patients with healthy immune systems aged ≥1 years.
Treatment recommendations
Treating patients with weakened immune systems
In people with healthy immune systems, nitazoxanide oral suspension (100 mg/5ml; patients ≥1 year of age) and nitazoxanide tablets (500 mg; patients ≥12 years of age) are indicated for the treatment of diarrhea caused by Cryptosporidium.
A single tablet contains a greater amount of nitazoxanide than recommended for pediatric dosing, and thus, should not be used for patients ages <11 years.
Dosage guidelines for people with healthy immune systems
Age | Dosage | Duration |
---|---|---|
1-3 years | 5 mL of ALINIA for Oral Suspension (100 mg nitazoxanide) every 12 hours with food | 3 days |
4-11 years | 10 mL of ALINIA for Oral Suspension (200 mg nitazoxanide) every 12 hours with food | |
12 years and older | One ALINIA Tablet (500 mg nitazoxanide) every 12 hours with food or 25 mL of ALINIA for Oral Suspension (500 mg nitazoxanide) every 12 hours with food |
Treatment efficacy
- Clinical cure (resolution of diarrhea) rates range from 72–88%.
- Parasitologic cure (Crypto undetectable in stool) rates range from 60–75%.
Healthcare professionals might consider retesting stool at least 1 week after the last dose of nitazoxanide only if symptoms do not resolve. In such cases, longer courses of treatment might be needed. Persistent symptoms can also represent reinfection or causes other than Cryptosporidium.
Nitazoxanide appears to be well tolerated and different treatment regimens have been used for a variety of infections. In patients with healthy immune systems, cryptosporidiosis has been treated with multiple 3-day courses of nitazoxanide; 7-day courses have also been used in early studies of cryptosporidiosis and other parasitic infections.
Precautions to prevent further spread
Cryptosporidium causes over half of the waterborne disease outbreaks associated with public swimming pools, hot tubs, and splash pads. Cryptosporidium's chlorine resistance and documented excretion for weeks after resolution of symptoms has led CDC and The American Academy of Pediatrics to recommend that patients refrain from swimming until two weeks after resolution of their symptoms. Following this recommendation will help prevent Cryptosporidium from being transmitted through recreational water.
- Fox LM, Saravolatz LD. Nitazoxanide: a new thiazolide antiparasitic agent. Clin Infect Dis. 2005 40(8):1173-80.
- White, AC Jr. Nitazoxanide: a new broad spectrum antiparasitic agent. Expert Rev Anti-infect Ther 2004 2(1):43-49.
- The Medical Letter, Drugs for Parasitic Infections. 2007. Also see FDA prescribing information [PDF – 8 pages].
- Rossignol JF, Ayoub A, Ayers MS. Treatment of diarrhea caused by Cryptosporidium parvum: a prospective randomized, double-blind, placebo-controlled study of Nitazoxanide. J Infect Dis. 2001 184(1):103-6.
- Diaz E, Mondragon J, Ramirez E, Bernal R. Epidemiology and control of intestinal parasites with nitazoxanide in children in Mexico. Am J Trop Med Hyg. 2003 68(4):384-5.
- Doumbo O, Rossignol JF, Pichard E, Traore HA, Dembele TM, Diakite M, Traore F, Diallo DA. Nitazoxanide in the treatment of cryptosporidial diarrhea and other intestinal parasitic infections associated with acquired immunodeficiency syndrome in tropical Africa. Am J Trop Med Hyg. 1997 56(6):637-9.
- Favennec L, Jave Ortiz J, Gargala G, Lopez Chegne N, Ayoub A, Rossignol JF. Double-blind, randomized, placebo-controlled study of nitazoxanide in the treatment of fascioliasis in adults and children from northern Peru. Aliment Pharmacol Ther. 2003 17(2):265-70.
- Rossignol JF, Hidalgo H, Feregrino M, Higuera F, Gomez WH, Romero JL, Padierna J, Geyne A, Ayers MS. A double-‘blind’ placebo-controlled study of nitazoxanide in the treatment of cryptosporidial diarrhea in AIDS patients in Mexico. Trans R Soc Trop Med Hyg. 1998 92(6):663-6.
- Dziuban EJ, Liang JL, Craun GF, Hill V, Yu PA, Painter J, Moore MR, Calderon RL, Roy SL, Beach MJ; Centers for Disease Control and Prevention (CDC). Surveillance for waterborne disease and outbreaks associated with recreational water–United States, 2003-2004. MMWR Surveill Summ. 2006 55(12):1-30.
- The American Academy of Pediatrics. In: Pickering LK, Baker CJ, Long SS, McMillan JA, eds. Red Book: 2006 Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village IL.
- Fox LM, Saravolatz LD. Nitazoxanide: a new thiazolide antiparasitic agent. Clin Infect Dis. 2005 40(8):1173–80.
- Hlavsa MC, Aluko SK, Miller AD, Person J, Gerdes ME, Lee S, Laco JP, Hannapel EJ, Hill VR. Outbreaks associated with treated recreational water — United States, 2015–2019. MMWR Morb Mortal Wkly Rep. 2021 70(20):733–8.
- Hlavsa MC, Roellig DM. Cryptosporidiosis. In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH eds. Red Book: 2021–2024 Report of the Committee on Infectious Diseases. 32nd ed. Itasca, IL: American Academy of Pediatrics; 2021:288–90.
- Patenburg B, Cabada MM, White AC. Treatment of cryptosporidiosis. Expert Rev Anti Infect Ther. 2009 7(4):385–91.