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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
Associated Therapies
-

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: Placebo
Drug: Nitazoxanide
Biological: Peginterferon alfa-2a
Drug: Ribavirin
First Posted Date
2007-07-03
Last Posted Date
2014-05-08
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
64
Registration Number
NCT00495391
Locations
🇺🇸

VA Palo Alto Healthcare System, Palo Alto, California, United States

🇺🇸

McGuire VA Medical Center, Richmond, Virginia, United States

🇺🇸

Nashville Medical Research Institute, Nashville, Tennessee, United States

and more 7 locations

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: Nitazoxanide
Biological: Peginterferon alfa-2a
Drug: Ribavirin
First Posted Date
2007-01-12
Last Posted Date
2008-09-25
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
121
Registration Number
NCT00421434
Locations
🇪🇬

Department of Tropical Medicine & Infectious Diseases, Alexandria University, Alexandria, Egypt

🇪🇬

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine, Tanta, Egypt

Study of Nitazoxanide in the Treatment of Chronic Hepatitis C

Phase 2
Completed
Conditions
Chronic Hepatitis C
First Posted Date
2007-01-05
Last Posted Date
2007-01-05
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
50
Registration Number
NCT00418639
Locations
🇪🇬

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine, Tanta, Egypt

🇪🇬

Cairo Liver & GIT Center, Cairo, Egypt

🇪🇬

Department of Tropical Medicine & Infectious Diseases, Alexandria University, Alexandria, Egypt

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Phase 2
Completed
Conditions
Clostridium Difficile
First Posted Date
2007-01-04
Last Posted Date
2007-01-04
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
114
Registration Number
NCT00417872
Locations
🇺🇸

WellStar Infectious Diseases, Marietta, Georgia, United States

🇺🇸

The Reading Hospital and Medical Center, West Reading, Pennsylvania, United States

🇺🇸

Remington-Davis, Inc., and Riverside Infection Consultants, Inc., Columbus, Ohio, United States

and more 4 locations

Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

Phase 3
Terminated
Conditions
Clostridium Infections
Interventions
First Posted Date
2006-10-06
Last Posted Date
2015-05-05
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
50
Registration Number
NCT00384527
Locations
🇺🇸

Michael E. Debakey VAMC, Houston, Texas, United States

🇺🇸

Bay Pines VAMC, Bay Pines, Florida, United States

🇺🇸

John D. Dingell VAMC, Ann Arbor, Michigan, United States

and more 7 locations

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

Phase 2
Terminated
Conditions
Crohn's Disease
Interventions
Other: Placebo
Drug: Nitazoxanide
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

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