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

• Sponsor: Romark Laboratories L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02612922
• Collaborator: (none)
• Enrollment: 325
• Locations: 28
• Arms: 2
• Duration (Months): 9.1
• Patients Per Site: 11.6
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Dec 1, 2015
• Actual Primary Completion Date: Sep 4, 2016
• Actual Study Completion Date: Sep 4, 2016

Arms and Interventions

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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Time to alleviation of all clinical symptoms of influenza [Up to 28 days]

Secondary Outcome Measures

1. Time to alleviation of each individual symptom of influenza [Up to 28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

1. 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.

1. 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.

1. 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.

1. 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.

2. Vaccination for seasonal influenza on or after August 1, 2015.

3. Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, peramivir, amantadine or rimantadine within 30 days prior to screening.

4. Prior treatment with any investigational drug therapy within 30 days prior to screening.

5. Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.

6. Known sensitivity to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.

7. Subjects unable to take oral medications.

8. Subject has chronic kidney or liver disease (including Hepatitis A, B or C) or known impaired hepatic and/or renal function.

9. Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy.

10. 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.

11. Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Influence Study Site	Hot Springs	Arkansas	United States	71913
2	Influence Study Site	Anaheim	California	United States	92805
3	Influence Study Site	Fresno	California	United States	93702
4	Influence Study Site	Lomita	California	United States	90717
5	Influence Study Site	Kissimmee	Florida	United States	34744
6	Influence Study Site	Lauderdale Lakes	Florida	United States	33319
7	Influence Study Site	Saint Cloud	Florida	United States	34769
8	Influence Study Site	Columbus	Georgia	United States	31904
9	Influence Study Site	Savannah	Georgia	United States	31401
10	Influence Study Site	Lansdale	Pennsylvania	United States	19446
11	Influence Study Site	Rapid City	South Dakota	United States	57702
12	Influence Study Site	Jackson	Tennessee	United States	38305
13	Influence Study Site	Austin	Texas	United States	78735
14	Influence Study Site	Houston	Texas	United States	77058
15	Influence Study Site	Pharr	Texas	United States	78577
16	Influence Study Site	Plano	Texas	United States	75024
17	Influence Study Site	Waco	Texas	United States	76710
18	Influence Study Site	Brookvale	New South Wales	Australia	2100
19	Influence Study Site	Castle Hill	New South Wales	Australia	2154
20	Influence Study Site	Mosman	New South Wales	Australia	2088
21	Influence Study Site	Browns Plains	Queensland	Australia	4118
22	Influence Study Site	Springfield	Queensland	Australia	4300
23	Influence Study Site	Berwick	Victoria	Australia	3806
24	Influence Study Site	Lynbrook	Victoria	Australia	3957
25	Influence Study Site	Rosebud	Victoria	Australia	3939
26	Influence Study Site	Tarneit	Victoria	Australia	3029
27	Influence Study Site	San Juan		Puerto Rico	00912
28	Influence Study Site	San Juan		Puerto Rico	00927

Sponsors and Collaborators

• Romark Laboratories L.C.

Investigators

• Study Director: Jean-Francois Rossignol, M.D., Ph.D., Romark Laboratories L.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Romark Laboratories L.C.
• ClinicalTrials.gov Identifier: NCT02612922
• Other Study ID Numbers: RM08-3003
• First Posted: Nov 24, 2015
• Last Update Posted: Apr 4, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Romark Laboratories L.C.: Influenza
• Additional relevant MeSH terms: Influenza, Human; Nitazoxanide

Study Results

No Results Posted as of Apr 4, 2018