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

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ClinicalTrials.gov Identifier: NCT02612922
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

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

Condition or disease Intervention/treatment Phase
Influenza Drug: Nitazoxanide Drug: Placebo Phase 3

Detailed Description:
A multicenter randomized double-blind placebo controlled trial designed to evaluate efficacy and safety of NTZ 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Double-Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Study Start Date : December 2015
Actual Primary Completion Date : September 4, 2016
Actual Study Completion Date : September 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days
Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for five days
Other Name: NTZ, Alinia

Placebo Comparator: Placebo
Two Placebo tablets orally twice daily (b.i.d.) for 5 days
Drug: Placebo
Placebo administered orally twice daily for five days




Primary Outcome Measures :
  1. Time to alleviation of all clinical symptoms of influenza [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Time to alleviation of each individual symptom of influenza [ Time Frame: Up to 28 days ]


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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 12 to 65 years
  2. 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).
  3. 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.
  4. 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.
  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. 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.
    • Alaskan natives.
  2. Females of childbearing potential who are either pregnant, breast-feeding or are sexually active without the use of birth control. Female subjects 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 August 1, 2015.
  4. Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, peramivir, 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. Subjects unable to take oral medications.
  9. Subject has chronic kidney or liver disease (including Hepatitis A, B or C) or known impaired hepatic and/or renal function.
  10. Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy.
  11. 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.
  12. Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612922


  Show 28 Study Locations
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Study Director: Jean-Francois Rossignol, M.D., Ph.D. Romark Laboratories L.C.

Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT02612922     History of Changes
Other Study ID Numbers: RM08-3003
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Romark Laboratories L.C.:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents