Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

NCT02612922 | Completed Phase 3

• 1 other identifier: RM08-3003
• Study Type: interventional
• Target: 325
• Locations: 3 countries
• Sites: 28

Brief Summary

Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute uncomplicated influenza.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Time to alleviation of all clinical symptoms of influenza

  Up to 28 days

Secondary Outcomes (1)

• Time to alleviation of each individual symptom of influenza

  Up to 28 days

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR

Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Two Placebo tablets orally twice daily (b.i.d.) for 5 days

Drug: Placebo

Interventions

Nitazoxanide DRUG

Nitazoxanide 600 mg administered orally twice daily for five days

Also known as: NTZ, Alinia

Nitazoxanide

Placebo DRUG

Placebo administered orally twice daily for five days

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12 to 65 years
• Presence of clinical signs and/or symptoms consistent with an 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), AND
• one of the following constitutional symptoms (fatigue, headache, myalgia, feverishness).
• Confirmation of influenza A or B infection in the local community by one of the following means:
• the institution's local laboratory,
• the local public health system,
• the national public health system, or
• a laboratory of a recognized national or multinational influenza surveillance scheme.
• Onset of illness no more than 40 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 12-65 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.
• Human Immunodeficiency Virus (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 active 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.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (28)

Influence Study Site

Hot Springs, Arkansas, 71913, United States

Location

Influence Study Site

Anaheim, California, 92805, United States

Location

Influence Study Site

Fresno, California, 93702, United States

Location

Influence Study Site

Lomita, California, 90717, United States

Location

Influence Study Site

Kissimmee, Florida, 34744, United States

Location

Influence Study Site

Lauderdale Lakes, Florida, 33319, United States

Location

Influence Study Site

Saint Cloud, Florida, 34769, United States

Location

Influence Study Site

Columbus, Georgia, 31904, United States

Location

Influence Study Site

Savannah, Georgia, 31401, United States

Location

Influence Study Site

Lansdale, Pennsylvania, 19446, United States

Location

Influence Study Site

Rapid City, South Dakota, 57702, United States

Location

Influence Study Site

Jackson, Tennessee, 38305, United States

Location

Influence Study Site

Austin, Texas, 78735, United States

Location

Influence Study Site

Houston, Texas, 77058, United States

Location

Influence Study Site

Pharr, Texas, 78577, United States

Location

Influence Study Site

Plano, Texas, 75024, United States

Location

Influence Study Site

Waco, Texas, 76710, United States

Location

Influence Study Site

Brookvale, New South Wales, 2100, Australia

Location

Influence Study Site

Castle Hill, New South Wales, 2154, Australia

Location

Influence Study Site

Mosman, New South Wales, 2088, Australia

Location

Influence Study Site

Browns Plains, Queensland, 4118, Australia

Location

Influence Study Site

Springfield, Queensland, 4300, Australia

Location

Influence Study Site

Berwick, Victoria, 3806, Australia

Location

Influence Study Site

Lynbrook, Victoria, 3957, Australia

Location

Influence Study Site

Rosebud, Victoria, 3939, Australia

Location

Influence Study Site

Tarneit, Victoria, 3029, Australia

Location

Influence Study Site

San Juan, 00912, Puerto Rico

Location

Influence Study Site

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

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

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: November 20, 2015
• First Posted: November 24, 2015
• Study Start: December 1, 2015
• Primary Completion: September 4, 2016
• Study Completion: September 4, 2016
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

PR (2); AU (9); US (17)