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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 65
Updated:4/17/2018
Start Date:December 2015
End Date:September 4, 2016

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A Phase III Randomized Double-Blind Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

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

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.

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.
We found this trial at
18
sites
Rapid City, South Dakota 57702
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Anaheim, California 92805
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Austin, Texas 78758
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Brookvale, New South Wales 2100
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Brookvale,
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Columbus, Georgia 31904
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Columbus, GA
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Fresno, California 93726
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Hot Springs, Arkansas 71913
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Houston, Texas 77062
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Houston, TX
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Jackson, Tennessee 38305
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Kissimmee, Florida 34741
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Lansdale, Pennsylvania 19446
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Lansdale, PA
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Lauderdale Lakes, Florida 33319
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Lomita, California 90719
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Lomita, CA
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Pharr, Texas 78577
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Pharr, TX
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Plano, Texas 75024
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2000 Bulldog Lane
Saint Cloud, Florida 34769
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Savannah, Georgia 31401
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Savannah, GA
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Waco, Texas 76712
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Waco, TX
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