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Nitazoxanide

Generic Name
Nitazoxanide
Brand Names
Alinia, Busulfex
Drug Type
Small Molecule
Chemical Formula
C12H9N3O5S
CAS Number
55981-09-4
Unique Ingredient Identifier
SOA12P041N
Background

Nitazoxanide belongs to the class of drugs known as thiazolides. Nitazoxanide (NTZ) is a broad-spectrum anti-infective drug that markedly modulates the survival, growth, and proliferation of a range of extracellular and intracellular protozoa, helminths, anaerobic and microaerophilic bacteria, in addition to viruses. This drug is effective in the treatment of gastrointestinal infections including Cryptosporidium parvum or Giardia lamblia in healthy subjects. It is generally well tolerated. Nitazoxanide is a first-line, standard treatment for illness caused by C. parvum or G. lamblia infection in healthy (not immunosuppressed) adults and children and may also be considered in the treatment of illnesses caused by other protozoa or helminths . Recently, this drug has been studied as a broad-spectrum antiviral agent due to its ability to inhibit the replication of several RNA and DNA viruses .

Indication

用于治疗隐孢子虫、贾第鞭毛虫、阿米巴原虫引起的原虫性腹泻。

Associated Conditions
Diarrhea caused by Cryptosporidium parvum, Diarrhea caused by Giardia lamblia

Study of Nitazoxanide in the Treatment of Amebiasis in Children

Phase 3
Completed
Conditions
Amebiasis
First Posted Date
2006-08-21
Last Posted Date
2006-08-21
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
50
Registration Number
NCT00366730
Locations
🇪🇬

Benha University Hospital, Benha, Egypt

🇪🇬

University Hospital, Alexandria, Egypt

Study of Nitazoxanide in the Treatment of Amebiasis in Adults and Adolescents

Phase 3
Completed
Conditions
Amebiasis
First Posted Date
2006-08-21
Last Posted Date
2006-08-21
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
50
Registration Number
NCT00366236
Locations
🇪🇬

Benha University Hospital, Benha, Egypt

🇪🇬

University Hospital, Alexandria, Egypt

Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

Phase 3
Completed
Conditions
Pseudomembranous Colitis
Clostridium Enterocolitis
Interventions
First Posted Date
2006-03-17
Last Posted Date
2017-12-15
Lead Sponsor
Daniel M. Musher MD
Target Recruit Count
22
Registration Number
NCT00304356
Locations
🇺🇸

Baylor College of Medicine, Houston, Texas, United States

🇺🇸

Michael E. Debakey VA Medical Center, Houston, Texas, United States

Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children

Phase 2
Completed
Conditions
Norovirus Infection
Rotavirus Infection
Adenoviridae Infection
Interventions
First Posted Date
2006-03-14
Last Posted Date
2012-05-31
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
50
Registration Number
NCT00302640

Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease

Phase 2
Terminated
Conditions
Crohn's Disease
Interventions
Other: Placebo
First Posted Date
2005-08-15
Last Posted Date
2012-05-31
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
98
Registration Number
NCT00130390
Locations
🇺🇸

Gastrointestinal Associates, LLC, Kingsport, Tennessee, United States

🇺🇸

Nashville Medical Research, Nashville, Tennessee, United States

🇺🇸

Romark Laboratories, L.C., Tampa, Florida, United States

and more 9 locations

Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children

Phase 1
Completed
Conditions
HIV Infections
Cryptosporidiosis
First Posted Date
2003-02-20
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
6
Registration Number
NCT00055107
Locations
🇹🇭

Siriraj Hospital Mahidol University CRS, Bangkok, Thailand

🇿🇦

Stellenbosch Univ. CRS, Cape Town, South Africa

A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium

Phase 2
Completed
Conditions
HIV Infections
Cryptosporidiosis
First Posted Date
2001-08-31
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
60
Registration Number
NCT00001081
Locations
🇺🇸

Cook County Hosp. CORE Ctr., Chicago, Illinois, United States

Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

Phase 3
Terminated
Conditions
Cryptosporidiosis
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
30
Registration Number
NCT00004986
Locations
🇺🇸

Julie Ryner, Tampa, Florida, United States

A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea

Phase 1
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Unimed Pharmaceuticals
Target Recruit Count
28
Registration Number
NCT00002444
Locations
🇺🇸

New York Hosp / Cornell Med Ctr, New York, New York, United States

A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis

Not Applicable
Conditions
Cryptosporidiosis
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2007-07-10
Lead Sponsor
Romark Laboratories L.C.
Registration Number
NCT00002158
Locations
🇺🇸

Romark Laboratories LC, Tampa, Florida, United States

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