Clinical trial NCT01227421 (phase 2/phase 3, status: completed)
Conditions: influenza
ICD codes: J11.81, J11.82, J10.01, J10.81, J10.82, J11.08, J11.2
Drugs: nitazoxanide, nitazoxanide, placebo
SMILES: CC(=O)OC1=CC=CC=C1C(=O)NC1=NC=C(S1)[N+]([O-])=O, CC(=O)OC1=CC=CC=C1C(=O)NC1=NC=C(S1)[N+]([O-])=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        INCLUSION CRITERIA

          -  age 12 to 65 years

          -  Presence of clinical signs, respiratory symptoms and constitutional symptoms
             compatible with influenza infection:

               1. fever,

               2. at least one of the following respiratory symptoms: cough, sore throat, nasal
                  discharge, nasal congestion, sneezing.

               3. At least one of the following constitutional symptoms: headache, myalgia, seats,
                  chills, fatigue of any severity (mild, moderate, severe)

          -  Confirmation of Influenza A or B infection in the local community

          -  Onset of illness no more than 48 hours before presentation. 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 patient experienced the presence of at
             least one respiratory symptom AND the presence of at least one constitutional symptom.

          -  willing and able to comply with protocol requirements and provide informed consent

        EXCLUSION CRITERIA:

          -  severity of illness requiring or anticipated to require in-hospital care

          -  High risk of complications from influenza as follows:

               1. persons with asthma or other chronic pulmonary diseases

               2. persons with hemodynamically significant cardiac disease

               3. persons who have immunosuppressive disorders or receiving immunosuppressive
                  therapy

               4. persons infected with Human Immunodeficiency Virus (HIV)

               5. persons with sickle cell anemia or other hemoglobinopathies

               6. persons with diseases requiring long-term aspirin therapy

               7. persons with chronic renal dysfunction

               8. persons with liver disorders

               9. Persons with cancer

              10. Persons with chronic metabolic disease such as diabetes and inherited
                  mitochondrial disorders

              11. Persons with neuromuscular disorders, seizure disorders, or cognitive dysfunction

              12. Residents of any age of nursing homes or long-term institutions.

          -  Females of child bearing age who are pregnant, breastfeeding or sexually active
             without birth control

          -  vaccination for influenza or H1N1 (Swine Flu) on or after August 1, 2010

          -  treatment with antiviral medication such as oseltamivir, zanamivir, amantadine, or
             rimantadine within 30 days of screening.

          -  Prior treatment with nitazoxanide within 30 days prior to screening.

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

          -  known sensitivity to nitazoxanide

          -  subjects unable to take oral medication

          -  subjects with chronic kidney or liver disease

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