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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:13 - 65
Updated:4/17/2018
Start Date:March 2013
End Date:April 16, 2015

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

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.


Inclusion Criteria:

1. Age 13 to 65 years

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. 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):

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.
We found this trial at
137
sites
La Crosse, Wisconsin 54601
1512
mi
from 98109
La Crosse, WI
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Albuquerque, New Mexico 87102
1184
mi
from 98109
Albuquerque, NM
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Alexandria, Virginia 22304
2321
mi
from 98109
Alexandria, VA
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Altoona, Pennsylvania 16602
2204
mi
from 98109
Altoona, PA
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Anaheim, California 92805
981
mi
from 98109
Anaheim, CA
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Ann Arbor, Michigan 48105
1902
mi
from 98109
Ann Arbor, MI
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Ashburn, Virginia 20147
2296
mi
from 98109
Ashburn, VA
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Ashland, Oregon 97520
376
mi
from 98109
Ashland, OR
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Atlanta, Georgia 30312
2179
mi
from 98109
Atlanta, GA
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Augusta, Kansas 67010
1451
mi
from 98109
Augusta, KS
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Austin, Texas 78758
1766
mi
from 98109
Austin, TX
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Beaumont, Texas 77701
1925
mi
from 98109
Beaumont, TX
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Birmingham, Alabama 35209
2081
mi
from 98109
Birmingham, AL
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Birmingham, Alabama 35209
2081
mi
from 98109
Birmingham, AL
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Blackfoot, Idaho 83221
573
mi
from 98109
Blackfoot, ID
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Boynton Beach, Florida 33472
2701
mi
from 98109
Boynton Beach, FL
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Bridgeton, Missouri 63044
1704
mi
from 98109
Bridgeton, MO
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Bristol, Tennessee 37620
2166
mi
from 98109
Bristol, TN
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Brooklyn, New York 11206
2405
mi
from 98109
Brooklyn, NY
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Brooklyn, New York 11206
2405
mi
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Brooklyn, NY
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Bryan, Texas 77802
1639
mi
from 98109
Bryan, TX
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Canton, Georgia 30114
2153
mi
from 98109
Canton, GA
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Cardiff, New South Wales
4702
mi
from 98109
Cardiff,
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Centennial, Colorado 80112
1032
mi
from 98109
Centennial, CO
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Charleston, South Carolina 29412
2425
mi
from 98109
Charleston, SC
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Charlotte, North Carolina 25205
2131
mi
from 98109
Charlotte, NC
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Charlotte, North Carolina 25205
2131
mi
from 98109
Charlotte, NC
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Charlottesville, Virginia 22908
2284
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Charlottesville, VA
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Chelsea, Michigan 48118
1888
mi
from 98109
Chelsea, MI
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Colorado Springs, Colorado 80920
1063
mi
from 98109
Colorado Springs, CO
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Colorado Springs, Colorado 80920
1063
mi
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Colorado Springs, CO
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Columbia, Tennessee 38401
1981
mi
from 98109
Columbia, TN
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Columbus, Georgia 31904
2207
mi
from 98109
Columbus, GA
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Columbus, Ohio 43214
2004
mi
from 98109
Columbus, OH
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Coral Gables, Florida 33134
2729
mi
from 98109
Coral Gables, FL
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Dayton, Ohio 45432
1959
mi
from 98109
Dayton, OH
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Dothan, Alabama 36305
2244
mi
from 98109
Dothan, AL
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Draper, Utah 84020
715
mi
from 98109
Draper, UT
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Edgewater, Florida 32132
2547
mi
from 98109
Edgewater, FL
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Elizabethton, Tennessee 37643
2174
mi
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Elizabethton, TN
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Essexville, Michigan 48732
1861
mi
from 98109
Essexville, MI
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Eunice, Louisiana 70535
1974
mi
from 98109
Eunice, LA
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Evansville, Indiana 47725
1863
mi
from 98109
Evansville, IN
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Fall River, Massachusetts 02720
2399
mi
from 98109
Fall River, MA
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Franklin, Indiana 46131
1882
mi
from 98109
Franklin, IN
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Franklin, Tennessee 37067
1976
mi
from 98109
Franklin, TN
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Fremont, Nebraska 68025
1335
mi
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Fremont, NE
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Fresno, California 93726
760
mi
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Fresno, CA
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Gainesville, Virginia 20155
2298
mi
from 98109
Gainesville, VA
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Garden Grove, California 92844
984
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Garden Grove, CA
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Great Neck, New York 11023
2412
mi
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Great Neck, NY
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Gresham, Oregon 97030
146
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Gresham, OR
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Groveport, Ohio 43125
2016
mi
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Groveport, OH
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Harbor City, California 90710
979
mi
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Harbor City, CA
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Hawesville, Kentucky 42348
1906
mi
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Hickory, North Carolina 28602
2238
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Hickory, NC
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Hoover, Alabama 35216
2084
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Hoover, AL
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Hot Springs, Arkansas 71913
1759
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Hot Springs, AR
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Houston, Texas 77062
1910
mi
from 98109
Houston, TX
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Houston, Texas 77062
1910
mi
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Houston, TX
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Huntington Beach, California 92647
987
mi
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Irving, Texas 75039
1667
mi
from 98109
Irving, TX
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Jackson, Tennessee 38305
1900
mi
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Jackson, TN
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Jonesboro, Arkansas 72401
1806
mi
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Jonesboro, AR
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Kansas City, Kansas 64133
1512
mi
from 98109
Kansas City, KS
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Kissimmee, Florida 34741
2556
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Kissimmee, FL
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LaFayette, Louisiana 70503
2004
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LaFayette, LA
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Lake Charles, Louisiana 70601
1953
mi
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Lake Charles, LA
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Lake Jackson, Texas 77566
1922
mi
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Lake Jackson, TX
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Lansdale, Pennsylvania 19446
2358
mi
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Lansdale, PA
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Las Vegas, Nevada 89102
874
mi
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Las Vegas, NV
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Las Vegas, Nevada 89102
874
mi
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Las Vegas, NV
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Lauderdale Lakes, Florida 33319
2712
mi
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Lauderdale Lakes, FL
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Littleton, Colorado 80128
1024
mi
from 98109
Littleton, CO
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Lomita, California 90719
978
mi
from 98109
Lomita, CA
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Long Beach, California 98013
17
mi
from 98109
Long Beach, CA
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Longmont, Colorado 80501
998
mi
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Longmont, CO
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Lyndhurst, Ohio 44124
2029
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Lyndhurst, OH
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Madisonville, Kentucky 42431
1893
mi
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Madisonville, KY
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Magna, Utah 84044
696
mi
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Magna, UT
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Mesa, Arizona 85206
1129
mi
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Mesa, AZ
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Mesa, Arizona 85206
1129
mi
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Mesa, AZ
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Miami, Florida 33174
2731
mi
from 98109
Miami, FL
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Middleburg Heights, Ohio 44130
2019
mi
from 98109
Middleburg Heights, OH
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Midlothian, Virginia 23114
2343
mi
from 98109
Midlothian, VA
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Milford, Ohio 45150
1974
mi
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Milford, OH
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Mobile, Alabama 36608
2139
mi
from 98109
Mobile, AL
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Modesto, California 95350
691
mi
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Modesto, CA
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Mooresville, North Carolina 28117
2268
mi
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Mooresville, NC
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Muncie, Indiana 47301
1890
mi
from 98109
Muncie, IN
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New York, New York 10016
2402
mi
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New York, NY
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Newton, Kansas 67114
1420
mi
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Newton, KS
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Niles, Michigan 49120
1798
mi
from 98109
Niles, MI
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Norco, California 92860
978
mi
from 98109
Norco, CA
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Norfolk, Virginia 23507
2430
mi
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Norfolk, VA
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North Richland Hills, Texas 76180
1660
mi
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North Richland Hills, TX
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Orem, Utah 84058
731
mi
from 98109
Orem, UT
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Orlando, Florida 32806
2549
mi
from 98109
Orlando, FL
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Owensboro, Kentucky 42303
1894
mi
from 98109
Owensboro, KY
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Pembroke Pines, Florida 33028
2719
mi
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Pembroke Pines, FL
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Pharr, Texas 78577
1977
mi
from 98109
Pharr, TX
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