Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

NCT01610245 | Completed Phase 3

• 1 other identifier: RM08-3002
• Study Type: interventional
• Target: 1,941
• Locations: 5 countries
• Sites: 167

Brief Summary

This study is a global multicenter randomized factorial double-blind, placebo-controlled trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days) in the treatment of acute uncomplicated influenza.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Time to resolution of all clinical symptoms of influenza as reported by the subjects

  Up to 28 days

Secondary Outcomes (1)

• Time to resolution of each individual symptom of influenza

  Up to 28 days

Study Arms (4)

Nitazoxanide

ACTIVE COMPARATOR

Two Nitazoxanide 300 mg tablets and one placebo capsule twice daily with food for 5 days

Drug: Nitazoxanide; Drug: Placebo Oral Capsule

Oseltamivir

ACTIVE COMPARATOR

Two placebo tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days

Drug: Oseltamivir; Drug: Placebo Oral Tablet

Nitazoxanide and Oseltamivir

ACTIVE COMPARATOR

Two nitazoxanide 300 mg tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days

Drug: Nitazoxanide; Drug: Oseltamivir

Placebo

PLACEBO COMPARATOR

Two placebo tablets and one placebo capsule with food twice daily for 5 days

Drug: Placebo Oral Tablet; Drug: Placebo Oral Capsule

Interventions

Nitazoxanide DRUG

Also known as: Alinia, NTZ (nitazoxanide)

Nitazoxanide; Nitazoxanide and Oseltamivir

Oseltamivir DRUG

Also known as: Tamiflu, OST (oseltamivir)

Nitazoxanide and Oseltamivir; Oseltamivir

Placebo Oral Tablet DRUG

Oseltamivir; Placebo

Placebo Oral Capsule DRUG

Nitazoxanide; Placebo

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 13 to 65 years
• Presence of clinical signs and/or symptoms consistent with acute illness compatible with influenza infection (each of the following is required):
• 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
• 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
• 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).
• Confirmation of influenza A or B infection in the local community by one of the following means:
• the institution's local laboratory, or
• the local public health system, or
• the national public health system, or
• a laboratory of a recognized national or multinational influenza surveillance scheme.
• 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:
• the time when the temperature was first measured as elevated, OR
• the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
• 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.

You may not qualify if:

• Severity of illness requiring or anticipated to require in-hospital care or subject defined as being at high risk of complications from influenza infection according to the Infectious Diseases Society of America (IDSA) guidelines for seasonal influenza in adults and children (Committee of Infectious Diseases (CID) 2009:48) or current Centers for Disease Control and Prevention (CDC) criteria. Current criteria for persons 13-65 years of age who are at risk of influenza complications include (list to be reviewed and updated as required prior to initiation of the study and at least monthly during the study):
• Persons with asthma or other chronic pulmonary diseases, such as cystic fibrosis in children or chronic obstructive pulmonary disease in adults.
• Persons with hemodynamically significant cardiac disease.
• Persons who have immunosuppressive disorders or who are receiving immunosuppressive therapy.
• HIV-infected persons.
• Persons with sickle cell anemia or other hemoglobinopathies.
• Persons with diseases requiring long-term aspirin therapy, such as rheumatoid arthritis or Kawasaki disease.
• Persons with chronic renal dysfunction.
• Persons with liver disorders.
• Persons with cancer.
• Persons with chronic metabolic disease, such as diabetes mellitus, inherited metabolic disorders and mitochondrial disorders.
• Persons with neuromuscular disorders, seizure disorders or cognitive dysfunction that may compromise the handling of respiratory secretions.
• Residents of any age of nursing homes or other long-term care institutions.
• Persons who are morbidly obese (Body Mass Index ≥40)
• American Indians (seemed to be at higher risk of complications last flu season)

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (167)

Influence Study Site

Birmingham, Alabama, 35209, United States

Location

Influence Study Site

Dothan, Alabama, 36305, United States

Location

Influence Study Site

Hoover, Alabama, 35216, United States

Location

Influence Study Site

Mobile, Alabama, 36608, United States

Location

Influence Study Site

Mesa, Arizona, 85206, United States

Location

Influence Study Site

Mesa, Arizona, 85213, United States

Location

Influence Study Site

Tucson, Arizona, 85741, United States

Location

Influence Study Site

Hot Springs, Arkansas, 71913, United States

Location

Influence Study Site

Jonesboro, Arkansas, 72401, United States

Location

Influence Study Site

Anaheim, California, 92805, United States

Location

Influence Study Site

Fresno, California, 93726, United States

Location

Influence Study Site

Garden Grove, California, 92844, United States

Location

Influence Study Site

Harbor City, California, 90710, United States

Location

Influence Study Site

Huntington Beach, California, 92647, United States

Location

Influence Study Site

Lomita, California, 90719, United States

Location

Influence Study Site

Long Beach, California, 98013, United States

Location

Influence Study Site

Modesto, California, 95350, United States

Location

Influence Study Site

Norco, California, 92860, United States

Location

Influence Study Site

San Ramon, California, 94582, United States

Location

Influence Study Site

Stockton, California, 95204, United States

Location

Influence Study Site

Centennial, Colorado, 80112, United States

Location

Influence Study Site

Colorado Springs, Colorado, 80906, United States

Location

Influence Study Site

Colorado Springs, Colorado, 80920, United States

Location

Influence Study Site

Littleton, Colorado, 80128, United States

Location

Influence Study Site

Longmont, Colorado, 80501, United States

Location

Influence Study Site

Thornton, Colorado, 80233, United States

Location

Influence Study Site

Boynton Beach, Florida, 33472, United States

Location

Influence Study Site

Coral Gables, Florida, 33134, United States

Location

Influence Study Site

Edgewater, Florida, 32132, United States

Location

Influence Study Site

Kissimmee, Florida, 34741, United States

Location

Influence Study Site

Lauderdale Lakes, Florida, 33319, United States

Location

Influence Study Site

Miami, Florida, 33174, United States

Location

Influence Study Site

Orlando, Florida, 32806, United States

Location

Influence Study Site

Pembroke Pines, Florida, 33028, United States

Location

Influence Study Site

Saint Cloud, Florida, 34769, United States

Location

Influence Study Site

West Palm Beach, Florida, 33406, United States

Location

Influence Study Site

Atlanta, Georgia, 30312, United States

Location

Influence Study Site

Canton, Georgia, 30114, United States

Location

Influence Study Site

Columbus, Georgia, 31904, United States

Location

Influence Study Site

Blackfoot, Idaho, 83221, United States

Location

Influence Study Site

Skokie, Illinois, 60077, United States

Location

Influence Study Site

Evansville, Indiana, 47725, United States

Location

Influence Study Site

Franklin, Indiana, 46131, United States

Location

Influence Study Site

Muncie, Indiana, 47301, United States

Location

Influence Study Site

Augusta, Kansas, 67010, United States

Location

Influence Study Site

Kansas City, Kansas, 64133, United States

Location

Influence Study Site

Newton, Kansas, 67114, United States

Location

Influence Study Site

Wichita, Kansas, 67205, United States

Location

Influence Study Site

Wichita, Kansas, 67207, United States

Location

Influence Study Site

Hawesville, Kentucky, 42348, United States

Location

Influence Study Site

Madisonville, Kentucky, 42431, United States

Location

Influence Study Site

Owensboro, Kentucky, 42303, United States

Location

Influence Study Site

Eunice, Louisiana, 70535, United States

Location

Influence Study Site

Lafayette, Louisiana, 70503, United States

Location

Influence Study Site

Lake Charles, Louisiana, 70601, United States

Location

Influence Study Site

Fall River, Massachusetts, 02720, United States

Location

Influence Study Site

Ann Arbor, Michigan, 48105, United States

Location

Influence Study Site

Chelsea, Michigan, 48118, United States

Location

Influence Study Site

Essexville, Michigan, 48732, United States

Location

Influence Study Site

Niles, Michigan, 49120, United States

Location

Influence Study Site

Troy, Michigan, 48098, United States

Location

Influence Study Site

Bridgeton, Missouri, 63044, United States

Location

Influence Study Site

Fremont, Nebraska, 68025, United States

Location

Influence Study Site

Las Vegas, Nevada, 89102, United States

Location

Influence Study Site

Las Vegas, Nevada, 89128, United States

Location

Influence Study Site

Teaneck, New Jersey, 07666, United States

Location

Influence Study Site

Albuquerque, New Mexico, 87102, United States

Location

Influence Study Site

Brooklyn, New York, 11203, United States

Location

Influence Study Site

Brooklyn, New York, 11206, United States

Location

Influence Study Site

Great Neck, New York, 11023, United States

Location

Influence Study Site

New York, New York, 10016, United States

Location

Influence Study Site

Rochester, New York, 14642, United States

Location

Influence Study Site

Westfield, New York, 14787, United States

Location

Influence Study Site

Charlotte, North Carolina, 25205, United States

Location

Influence Study Site

Charlotte, North Carolina, 28209, United States

Location

Influence Study Site

Hickory, North Carolina, 28602, United States

Location

Influence Study Site

Mooresville, North Carolina, 28117, United States

Location

Influence Study Site

Winston-Salem, North Carolina, 27103, United States

Location

Influence Study Site

Columbus, Ohio, 43214, United States

Location

Influence Study Site

Dayton, Ohio, 45432, United States

Location

Influence Study Site

Groveport, Ohio, 43125, United States

Location

Influence Study Site

Lyndhurst, Ohio, 44124, United States

Location

Influence Study Site

Middleburg Heights, Ohio, 44130, United States

Location

Influence Study Site

Milford, Ohio, 45150, United States

Location

Influence Study Site

Willoughby Hills, Ohio, 44094, United States

Location

Influence Study Site

Wooster, Ohio, 44691, United States

Location

Influence Study Site

Tulsa, Oklahoma, 74136, United States

Location

Influence Study Site

Ashland, Oregon, 97520, United States

Location

Influence Study Site

Gresham, Oregon, 97030, United States

Location

Influence Study Site

Altoona, Pennsylvania, 16602, United States

Location

Influence Study Site

Lansdale, Pennsylvania, 19446, United States

Location

Influence Study Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Influence Study Site

Pittsburgh, Pennsylvania, 15236, United States

Location

Influence Study Site

Reading, Pennsylvania, 19606, United States

Location

Influence Study Site

Scottdale, Pennsylvania, 15683, United States

Location

Influence Study Site

Uniontown, Pennsylvania, 15401, United States

Location

Influence Study Site

Warwick, Rhode Island, 02886, United States

Location

Influence Study Site

Charleston, South Carolina, 29412, United States

Location

Influence Study Site

Rapid City, South Dakota, 57701, United States

Location

Influence Study Site

Rapid City, South Dakota, 57702, United States

Location

Influence Study Site

Bristol, Tennessee, 37620, United States

Location

Influence Study Site

Columbia, Tennessee, 38401, United States

Location

Influence Study Site

Elizabethton, Tennessee, 37643, United States

Location

Influence Study Site

Franklin, Tennessee, 37067, United States

Location

Influence Study Site

Jackson, Tennessee, 38305, United States

Location

Influence Study Site

Smyrna, Tennessee, 37167, United States

Location

Influence Study Site

Austin, Texas, 78758, United States

Location

Influence Study Site

Beaumont, Texas, 77701, United States

Location

Influence Study Site

Bryan, Texas, 77802, United States

Location

Influence Study Site

Houston, Texas, 77055, United States

Location

Influence Study Site

Houston, Texas, 77062, United States

Location

Influence Study Site

Irving, Texas, 75039, United States

Location

Influence Study Site

Lake Jackson, Texas, 77566, United States

Location

Influence Study Site

North Richland Hills, Texas, 76180, United States

Location

Influence Study Site

Pharr, Texas, 78577, United States

Location

Influence Study Site

Plano, Texas, 75024, United States

Location

Influence Study Site

San Antonio, Texas, 77566, United States

Location

Influence Study Site

San Antonio, Texas, 78207, United States

Location

Influence Study Site

San Antonio, Texas, 78258, United States

Location

Influence Study Site

Sugar Land, Texas, 77479, United States

Location

Influence Study Site

Waco, Texas, 76712, United States

Location

Influence Study Site

Draper, Utah, 84020, United States

Location

Influence Study Site

Magna, Utah, 84044, United States

Location

Influence Study Site

Orem, Utah, 84058, United States

Location

Influence Study Site

Salt Lake City, Utah, 84117, United States

Location

Influence Study Site

Alexandria, Virginia, 22304, United States

Location

Influence Study Site

Ashburn, Virginia, 20147, United States

Location

Influence Study Site

Charlottesville, Virginia, 22908, United States

Location

Influence Study Site

Gainesville, Virginia, 20155, United States

Location

Influence Study Site

Midlothian, Virginia, 23114, United States

Location

Influence Study Site

Norfolk, Virginia, 23507, United States

Location

Influence Study Site

Virginia Beach, Virginia, 23455, United States

Location

Influence Study Site

Port Orchard, Washington, 98366, United States

Location

Influence Study Site

Spokane, Washington, 99202, United States

Location

Influence Study Site

Spokane, Washington, 99218, United States

Location

Influence Study Site

La Crosse, Wisconsin, 54601, United States

Location

Influence Study Site

Cardiff, New South Wales, 2285, Australia

Location

Influence Study Site

Castle Hill, New South Wales, 2154, Australia

Location

Influence Study Site

Darlinghurst, New South Wales, 2010, Australia

Location

Influence Study Site

Westmead, Sydney, New South Wales, 2145, Australia

Location

Influence Study Site

Chermside, Queensland, 4032, Australia

Location

Influence Study Site

Sherwood, Queensland, 4075, Australia

Location

Influence Study Site

Daw Park, South Australia, 5041, Australia

Location

Influence Study Site

Clayton, Victoria, 3168, Australia

Location

Influence Study Site

Fitzroy North, Victoria, 3068, Australia

Location

Influence Study Site

Prahran, Victoria, 3181, Australia

Location

Influence Study SIte

Nedlands, Western Australia, 6009, Australia

Location

Influence Study Site

Antwerp, 2060, Belgium

Location

Influence Study Site

Coquitlam, British Columbia, V3K3P4, Canada

Location

Influence Study Site

Langley, British Columbia, V3A4H9, Canada

Location

Influence Study Site

Surrey, British Columbia, V3S2N6, Canada

Location

Influence Study Site

Brampton, Ontario, L6W2A4, Canada

Location

Influence Study Site

London, Ontario, N5Y5K7, Canada

Location

Influence Study Site

Niagara Falls, Ontario, L2E 6S5, Canada

Location

Influence Study Site

Sarnia, Ontario, N7T4X3, Canada

Location

Influence Study Site

Toronto, Ontario, M4S1Y2, Canada

Location

Influence Study Site

Toronto, Ontario, M9W4L6, Canada

Location

Influence Study Site

Mirabel, Quebec, J7J2K8, Canada

Location

Influence Study Site

Montreal, Quebec, H1T2M4, Canada

Location

Influence Study Site

Pointe-Claire, Quebec, H9R4S3, Canada

Location

Influence Study Site

Birkenhead, Auckland, 626, New Zealand

Location

Influence Study Site

Grafton, Auckland, 1010, New Zealand

Location

Influence Study Site

Remuera, Auckland, 1050, New Zealand

Location

Influence Study Site

Rotorua, Bay of Plenty, 3010, New Zealand

Location

Influence Study Site

Tauranga, Bay of Plenty, 3112, New Zealand

Location

Influence Study Site

Beckenham, Christchurch, 8061, New Zealand

Location

Influence Study Site

Christchurch Central, Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

nitazoxanide; Oseltamivir; dolichyl-diphosphooligosaccharide - protein glycotransferase

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jean-Francois Rossignol, M.D., Ph.D.

  Romark Laboratories L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2012
• First Posted: June 1, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 16, 2015
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

CA (12); NZ (7); BE (1); US (136); AU (11)