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

Use our guide to learn which trials are right for you!

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
Salt Lake City, Utah 84117
1512
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
Alexandria, Virginia 22304
325
mi
from 43215
Alexandria, VA
Click here to add this to my saved trials
Altoona, Pennsylvania 16602
247
mi
from 43215
Altoona, PA
Click here to add this to my saved trials
Anaheim, California 92805
1960
mi
from 43215
Anaheim, CA
Click here to add this to my saved trials
Ann Arbor, Michigan 48105
164
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
Ashburn, Virginia 20147
301
mi
from 43215
Ashburn, VA
Click here to add this to my saved trials
Ashland, Oregon 97520
2053
mi
from 43215
Ashland, OR
Click here to add this to my saved trials
Atlanta, Georgia 30312
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
Augusta, Kansas 67010
766
mi
from 43215
Augusta, KS
Click here to add this to my saved trials
Austin, Texas 78758
1058
mi
from 43215
Austin, TX
Click here to add this to my saved trials
Beaumont, Texas 77701
925
mi
from 43215
Beaumont, TX
Click here to add this to my saved trials
Birmingham, Alabama 35209
495
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35209
495
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
Blackfoot, Idaho 83221
1523
mi
from 43215
Blackfoot, ID
Click here to add this to my saved trials
Boynton Beach, Florida 33472
943
mi
from 43215
Boynton Beach, FL
Click here to add this to my saved trials
Bridgeton, Missouri 63044
404
mi
from 43215
Bridgeton, MO
Click here to add this to my saved trials
Bristol, Tennessee 37620
237
mi
from 43215
Bristol, TN
Click here to add this to my saved trials
Brooklyn, New York 11206
480
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
Brooklyn, New York 11206
480
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
Bryan, Texas 77802
927
mi
from 43215
Bryan, TX
Click here to add this to my saved trials
Canton, Georgia 30114
403
mi
from 43215
Canton, GA
Click here to add this to my saved trials
Cardiff, New South Wales
3736
mi
from 43215
Cardiff,
Click here to add this to my saved trials
Centennial, Colorado 80112
1157
mi
from 43215
Centennial, CO
Click here to add this to my saved trials
Charleston, South Carolina 29412
529
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 25205
149
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 25205
149
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22908
277
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
Chelsea, Michigan 48118
170
mi
from 43215
Chelsea, MI
Click here to add this to my saved trials
Colorado Springs, Colorado 80920
1159
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80920
1159
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Tennessee 38401
371
mi
from 43215
Columbia, TN
Click here to add this to my saved trials
Columbus, Georgia 31904
529
mi
from 43215
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43214
5
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
Coral Gables, Florida 33134
994
mi
from 43215
Coral Gables, FL
Click here to add this to my saved trials
Dayton, Ohio 45432
63
mi
from 43215
Dayton, OH
Click here to add this to my saved trials
Dothan, Alabama 36305
618
mi
from 43215
Dothan, AL
Click here to add this to my saved trials
Draper, Utah 84020
1515
mi
from 43215
Draper, UT
Click here to add this to my saved trials
Edgewater, Florida 32132
767
mi
from 43215
Edgewater, FL
Click here to add this to my saved trials
Elizabethton, Tennessee 37643
253
mi
from 43215
Elizabethton, TN
Click here to add this to my saved trials
Essexville, Michigan 48732
255
mi
from 43215
Essexville, MI
Click here to add this to my saved trials
Eunice, Louisiana 70535
841
mi
from 43215
Eunice, LA
Click here to add this to my saved trials
Evansville, Indiana 47725
273
mi
from 43215
Evansville, IN
Click here to add this to my saved trials
Fall River, Massachusetts 02720
539
mi
from 43215
Fall River, MA
Click here to add this to my saved trials
Franklin, Indiana 46131
164
mi
from 43215
Franklin, IN
Click here to add this to my saved trials
Franklin, Tennessee 37067
348
mi
from 43215
Franklin, TN
Click here to add this to my saved trials
Fremont, Nebraska 68025
712
mi
from 43215
Fremont, NE
Click here to add this to my saved trials
Fresno, California 93726
1987
mi
from 43215
Fresno, CA
Click here to add this to my saved trials
Gainesville, Virginia 20155
299
mi
from 43215
Gainesville, VA
Click here to add this to my saved trials
Garden Grove, California 92844
1965
mi
from 43215
Garden Grove, CA
Click here to add this to my saved trials
Great Neck, New York 11023
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
Gresham, Oregon 97030
2014
mi
from 43215
Gresham, OR
Click here to add this to my saved trials
Groveport, Ohio 43125
9
mi
from 43215
Groveport, OH
Click here to add this to my saved trials
Harbor City, California 90710
1981
mi
from 43215
Harbor City, CA
Click here to add this to my saved trials
Hawesville, Kentucky 42348
246
mi
from 43215
Hawesville, KY
Click here to add this to my saved trials
Hickory, North Carolina 28602
306
mi
from 43215
Hickory, NC
Click here to add this to my saved trials
Hoover, Alabama 35216
499
mi
from 43215
Hoover, AL
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
667
mi
from 43215
Hot Springs, AR
Click here to add this to my saved trials
Houston, Texas 77062
992
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77062
992
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92647
1968
mi
from 43215
Huntington Beach, CA
Click here to add this to my saved trials
Irving, Texas 75039
914
mi
from 43215
Irving, TX
Click here to add this to my saved trials
Jackson, Tennessee 38305
436
mi
from 43215
Jackson, TN
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
506
mi
from 43215
Jonesboro, AR
Click here to add this to my saved trials
Kansas City, Kansas 64133
612
mi
from 43215
Kansas City, KS
Click here to add this to my saved trials
Kissimmee, Florida 34741
810
mi
from 43215
Kissimmee, FL
Click here to add this to my saved trials
La Crosse, Wisconsin 54601
498
mi
from 43215
La Crosse, WI
Click here to add this to my saved trials
LaFayette, Louisiana 70503
842
mi
from 43215
LaFayette, LA
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
885
mi
from 43215
Lake Charles, LA
Click here to add this to my saved trials
Lake Jackson, Texas 77566
1032
mi
from 43215
Lake Jackson, TX
Click here to add this to my saved trials
Lansdale, Pennsylvania 19446
409
mi
from 43215
Lansdale, PA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33319
967
mi
from 43215
Lauderdale Lakes, FL
Click here to add this to my saved trials
Littleton, Colorado 80128
1164
mi
from 43215
Littleton, CO
Click here to add this to my saved trials
Lomita, California 90719
1982
mi
from 43215
Lomita, CA
Click here to add this to my saved trials
Long Beach, California 98013
2012
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
Longmont, Colorado 80501
1164
mi
from 43215
Longmont, CO
Click here to add this to my saved trials
Lyndhurst, Ohio 44124
134
mi
from 43215
Lyndhurst, OH
Click here to add this to my saved trials
Madisonville, Kentucky 42431
302
mi
from 43215
Madisonville, KY
Click here to add this to my saved trials
Magna, Utah 84044
1525
mi
from 43215
Magna, UT
Click here to add this to my saved trials
Mesa, Arizona 85206
1644
mi
from 43215
Mesa, AZ
Click here to add this to my saved trials
Mesa, Arizona 85206
1644
mi
from 43215
Mesa, AZ
Click here to add this to my saved trials
Miami, Florida 33174
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
Middleburg Heights, Ohio 44130
115
mi
from 43215
Middleburg Heights, OH
Click here to add this to my saved trials
Midlothian, Virginia 23114
335
mi
from 43215
Midlothian, VA
Click here to add this to my saved trials
Milford, Ohio 45150
86
mi
from 43215
Milford, OH
Click here to add this to my saved trials
Mobile, Alabama 36608
707
mi
from 43215
Mobile, AL
Click here to add this to my saved trials
Modesto, California 95350
2034
mi
from 43215
Modesto, CA
Click here to add this to my saved trials
Mooresville, North Carolina 28117
325
mi
from 43215
Mooresville, NC
Click here to add this to my saved trials
Muncie, Indiana 47301
125
mi
from 43215
Muncie, IN
Click here to add this to my saved trials
New York, New York 10016
478
mi
from 43215
New York, NY
Click here to add this to my saved trials
Newton, Kansas 67114
779
mi
from 43215
Newton, KS
Click here to add this to my saved trials
Niles, Michigan 49120
212
mi
from 43215
Niles, MI
Click here to add this to my saved trials
Norco, California 92860
1938
mi
from 43215
Norco, CA
Click here to add this to my saved trials
Norfolk, Virginia 23507
423
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
North Richland Hills, Texas 76180
929
mi
from 43215
North Richland Hills, TX
Click here to add this to my saved trials
Orem, Utah 84058
1508
mi
from 43215
Orem, UT
Click here to add this to my saved trials
Orlando, Florida 32806
797
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
Owensboro, Kentucky 42303
267
mi
from 43215
Owensboro, KY
Click here to add this to my saved trials
Pembroke Pines, Florida 33028
978
mi
from 43215
Pembroke Pines, FL
Click here to add this to my saved trials