Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
NCT ID: NCT01610245
Last Updated: 2018-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1941 participants
INTERVENTIONAL
2013-03-31
2015-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nitazoxanide
Two Nitazoxanide 300 mg tablets and one placebo capsule twice daily with food for 5 days
Nitazoxanide
Placebo Oral Capsule
Oseltamivir
Two placebo tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days
Oseltamivir
Placebo Oral Tablet
Nitazoxanide and Oseltamivir
Two nitazoxanide 300 mg tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days
Nitazoxanide
Oseltamivir
Placebo
Two placebo tablets and one placebo capsule with food twice daily for 5 days
Placebo Oral Tablet
Placebo Oral Capsule
Interventions
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Nitazoxanide
Oseltamivir
Placebo Oral Tablet
Placebo Oral Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Presence of clinical signs and/or symptoms consistent with acute illness compatible with influenza infection (each of the following is required):
1. oral temperature of ≥100.4 °F or ≥38 °C (obtained in office or self-measured within 12 hours prior to screening - if self-measured, subject must also have taken an antipyretic within 4 hours prior to screening) AND
2. at least one of the following respiratory symptoms (cough, sore throat, nasal obstruction) that is considered by the patient to be moderate or severe (greater than mild severity) AND
3. one of the following constitutional symptoms (fatigue, headache, myalgia, feverishness) that is considered by the patient to be moderate or severe (greater than mild severity).
3. Confirmation of influenza A or B infection in the local community by one of the following means:
1. the institution's local laboratory, or
2. the local public health system, or
3. the national public health system, or
4. a laboratory of a recognized national or multinational influenza surveillance scheme.
4. Onset of illness no more than 48 hours before enrollment in the trial.
Note: Time of onset of illness is defined as either the earlier of:
1. the time when the temperature was first measured as elevated, OR
2. the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
5. Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the patient diary.
Exclusion Criteria
1. Persons with asthma or other chronic pulmonary diseases, such as cystic fibrosis in children or chronic obstructive pulmonary disease in adults.
2. Persons with hemodynamically significant cardiac disease.
3. Persons who have immunosuppressive disorders or who are receiving immunosuppressive therapy.
4. HIV-infected persons.
5. Persons with sickle cell anemia or other hemoglobinopathies.
6. Persons with diseases requiring long-term aspirin therapy, such as rheumatoid arthritis or Kawasaki disease.
7. Persons with chronic renal dysfunction.
8. Persons with liver disorders.
9. Persons with cancer.
10. Persons with chronic metabolic disease, such as diabetes mellitus, inherited metabolic disorders and mitochondrial disorders.
11. Persons with neuromuscular disorders, seizure disorders or cognitive dysfunction that may compromise the handling of respiratory secretions.
12. Residents of any age of nursing homes or other long-term care institutions.
13. Persons who are morbidly obese (Body Mass Index ≥40)
14. American Indians (seemed to be at higher risk of complications last flu season)
15. Alaskan natives (seemed to be at higher risk of complications last flu season)
2. Females of childbearing potential who are either pregnant, breast-feeding or are sexually active without the use of birth control. Female patients of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an intrauterine device (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral ovariectomy.
3. Vaccination for seasonal influenza on or after i. August 1, 2012 in the case of subjects enrolled during the 2012/2013 flu season in the United States, ii. February 1, 2013 in the case of subjects enrolled during the 2013 flu season in Australia or New Zealand, or iii. August 1, 2013 in the case of subjects enrolled during the 2013/2014 flu season in the United States, Canada, Europe, or other countries in the Northern Hemisphere, or iv. February 1, 2014 in the case of subjects enrolled during the 2014 flu season in Australia or New Zealand, or v. August 1, 2014 in the case of subjects enrolled during the 2014/2015 flu season in the United States, Canada, Europe, or other countries in the Northern Hemisphere.
4. Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, amantadine, or rimantadine within 30 days prior to screening.
5. Prior treatment with any investigational drug therapy within 30 days prior to screening.
6. Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
7. Known sensitivity to Nitazoxanide or any of the excipients comprising the Nitazoxanide tablets.
8. Known sensitivity to Oseltamivir or any of the excipients comprising the Oseltamivir capsules.
9. Subjects unable to take oral medications.
10. Subject has chronic kidney or liver disease (including Hepatitis A,B or C) or known impaired hepatic and/or renal function.
11. Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy.
12. Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
13. Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
13 Years
65 Years
ALL
No
Sponsors
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Romark Laboratories L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Francois Rossignol, M.D., Ph.D.
Role: STUDY_DIRECTOR
Romark Laboratories L.C.
Locations
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Influence Study Site
Birmingham, Alabama, United States
Influence Study Site
Dothan, Alabama, United States
Influence Study Site
Hoover, Alabama, United States
Influence Study Site
Mobile, Alabama, United States
Influence Study Site
Mesa, Arizona, United States
Influence Study Site
Mesa, Arizona, United States
Influence Study Site
Tucson, Arizona, United States
Influence Study Site
Hot Springs, Arkansas, United States
Influence Study Site
Jonesboro, Arkansas, United States
Influence Study Site
Anaheim, California, United States
Influence Study Site
Fresno, California, United States
Influence Study Site
Garden Grove, California, United States
Influence Study Site
Harbor City, California, United States
Influence Study Site
Huntington Beach, California, United States
Influence Study Site
Lomita, California, United States
Influence Study Site
Long Beach, California, United States
Influence Study Site
Modesto, California, United States
Influence Study Site
Norco, California, United States
Influence Study Site
San Ramon, California, United States
Influence Study Site
Stockton, California, United States
Influence Study Site
Centennial, Colorado, United States
Influence Study Site
Colorado Springs, Colorado, United States
Influence Study Site
Colorado Springs, Colorado, United States
Influence Study Site
Littleton, Colorado, United States
Influence Study Site
Longmont, Colorado, United States
Influence Study Site
Thornton, Colorado, United States
Influence Study Site
Boynton Beach, Florida, United States
Influence Study Site
Coral Gables, Florida, United States
Influence Study Site
Edgewater, Florida, United States
Influence Study Site
Kissimmee, Florida, United States
Influence Study Site
Lauderdale Lakes, Florida, United States
Influence Study Site
Miami, Florida, United States
Influence Study Site
Orlando, Florida, United States
Influence Study Site
Pembroke Pines, Florida, United States
Influence Study Site
Saint Cloud, Florida, United States
Influence Study Site
West Palm Beach, Florida, United States
Influence Study Site
Atlanta, Georgia, United States
Influence Study Site
Canton, Georgia, United States
Influence Study Site
Columbus, Georgia, United States
Influence Study Site
Blackfoot, Idaho, United States
Influence Study Site
Skokie, Illinois, United States
Influence Study Site
Evansville, Indiana, United States
Influence Study Site
Franklin, Indiana, United States
Influence Study Site
Muncie, Indiana, United States
Influence Study Site
Augusta, Kansas, United States
Influence Study Site
Kansas City, Kansas, United States
Influence Study Site
Newton, Kansas, United States
Influence Study Site
Wichita, Kansas, United States
Influence Study Site
Wichita, Kansas, United States
Influence Study Site
Hawesville, Kentucky, United States
Influence Study Site
Madisonville, Kentucky, United States
Influence Study Site
Owensboro, Kentucky, United States
Influence Study Site
Eunice, Louisiana, United States
Influence Study Site
Lafayette, Louisiana, United States
Influence Study Site
Lake Charles, Louisiana, United States
Influence Study Site
Fall River, Massachusetts, United States
Influence Study Site
Ann Arbor, Michigan, United States
Influence Study Site
Chelsea, Michigan, United States
Influence Study Site
Essexville, Michigan, United States
Influence Study Site
Niles, Michigan, United States
Influence Study Site
Troy, Michigan, United States
Influence Study Site
Bridgeton, Missouri, United States
Influence Study Site
Fremont, Nebraska, United States
Influence Study Site
Las Vegas, Nevada, United States
Influence Study Site
Las Vegas, Nevada, United States
Influence Study Site
Teaneck, New Jersey, United States
Influence Study Site
Albuquerque, New Mexico, United States
Influence Study Site
Brooklyn, New York, United States
Influence Study Site
Brooklyn, New York, United States
Influence Study Site
Great Neck, New York, United States
Influence Study Site
New York, New York, United States
Influence Study Site
Rochester, New York, United States
Influence Study Site
Westfield, New York, United States
Influence Study Site
Charlotte, North Carolina, United States
Influence Study Site
Charlotte, North Carolina, United States
Influence Study Site
Hickory, North Carolina, United States
Influence Study Site
Mooresville, North Carolina, United States
Influence Study Site
Winston-Salem, North Carolina, United States
Influence Study Site
Columbus, Ohio, United States
Influence Study Site
Dayton, Ohio, United States
Influence Study Site
Groveport, Ohio, United States
Influence Study Site
Lyndhurst, Ohio, United States
Influence Study Site
Middleburg Heights, Ohio, United States
Influence Study Site
Milford, Ohio, United States
Influence Study Site
Willoughby Hills, Ohio, United States
Influence Study Site
Wooster, Ohio, United States
Influence Study Site
Tulsa, Oklahoma, United States
Influence Study Site
Ashland, Oregon, United States
Influence Study Site
Gresham, Oregon, United States
Influence Study Site
Altoona, Pennsylvania, United States
Influence Study Site
Lansdale, Pennsylvania, United States
Influence Study Site
Pittsburgh, Pennsylvania, United States
Influence Study Site
Pittsburgh, Pennsylvania, United States
Influence Study Site
Reading, Pennsylvania, United States
Influence Study Site
Scottdale, Pennsylvania, United States
Influence Study Site
Uniontown, Pennsylvania, United States
Influence Study Site
Warwick, Rhode Island, United States
Influence Study Site
Charleston, South Carolina, United States
Influence Study Site
Rapid City, South Dakota, United States
Influence Study Site
Rapid City, South Dakota, United States
Influence Study Site
Bristol, Tennessee, United States
Influence Study Site
Columbia, Tennessee, United States
Influence Study Site
Elizabethton, Tennessee, United States
Influence Study Site
Franklin, Tennessee, United States
Influence Study Site
Jackson, Tennessee, United States
Influence Study Site
Smyrna, Tennessee, United States
Influence Study Site
Austin, Texas, United States
Influence Study Site
Beaumont, Texas, United States
Influence Study Site
Bryan, Texas, United States
Influence Study Site
Houston, Texas, United States
Influence Study Site
Houston, Texas, United States
Influence Study Site
Irving, Texas, United States
Influence Study Site
Lake Jackson, Texas, United States
Influence Study Site
North Richland Hills, Texas, United States
Influence Study Site
Pharr, Texas, United States
Influence Study Site
Plano, Texas, United States
Influence Study Site
San Antonio, Texas, United States
Influence Study Site
San Antonio, Texas, United States
Influence Study Site
San Antonio, Texas, United States
Influence Study Site
Sugar Land, Texas, United States
Influence Study Site
Waco, Texas, United States
Influence Study Site
Draper, Utah, United States
Influence Study Site
Magna, Utah, United States
Influence Study Site
Orem, Utah, United States
Influence Study Site
Salt Lake City, Utah, United States
Influence Study Site
Alexandria, Virginia, United States
Influence Study Site
Ashburn, Virginia, United States
Influence Study Site
Charlottesville, Virginia, United States
Influence Study Site
Gainesville, Virginia, United States
Influence Study Site
Midlothian, Virginia, United States
Influence Study Site
Norfolk, Virginia, United States
Influence Study Site
Virginia Beach, Virginia, United States
Influence Study Site
Port Orchard, Washington, United States
Influence Study Site
Spokane, Washington, United States
Influence Study Site
Spokane, Washington, United States
Influence Study Site
La Crosse, Wisconsin, United States
Influence Study Site
Cardiff, New South Wales, Australia
Influence Study Site
Castle Hill, New South Wales, Australia
Influence Study Site
Darlinghurst, New South Wales, Australia
Influence Study Site
Westmead, Sydney, New South Wales, Australia
Influence Study Site
Chermside, Queensland, Australia
Influence Study Site
Sherwood, Queensland, Australia
Influence Study Site
Daw Park, South Australia, Australia
Influence Study Site
Clayton, Victoria, Australia
Influence Study Site
Fitzroy North, Victoria, Australia
Influence Study Site
Prahran, Victoria, Australia
Influence Study SIte
Nedlands, Western Australia, Australia
Influence Study Site
Antwerp, , Belgium
Influence Study Site
Coquitlam, British Columbia, Canada
Influence Study Site
Langley, British Columbia, Canada
Influence Study Site
Surrey, British Columbia, Canada
Influence Study Site
Brampton, Ontario, Canada
Influence Study Site
London, Ontario, Canada
Influence Study Site
Niagara Falls, Ontario, Canada
Influence Study Site
Sarnia, Ontario, Canada
Influence Study Site
Toronto, Ontario, Canada
Influence Study Site
Toronto, Ontario, Canada
Influence Study Site
Mirabel, Quebec, Canada
Influence Study Site
Montreal, Quebec, Canada
Influence Study Site
Pointe-Claire, Quebec, Canada
Influence Study Site
Birkenhead, Auckland, New Zealand
Influence Study Site
Grafton, Auckland, New Zealand
Influence Study Site
Remuera, Auckland, New Zealand
Influence Study Site
Rotorua, Bay of Plenty, New Zealand
Influence Study Site
Tauranga, Bay of Plenty, New Zealand
Influence Study Site
Beckenham, Christchurch, New Zealand
Influence Study Site
Christchurch Central, Christchurch, New Zealand
Countries
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Other Identifiers
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RM08-3002
Identifier Type: -
Identifier Source: org_study_id
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