Status and phase
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Treatments
About
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of acute uncomplicated influenza.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age 12 to 65 years
Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection (each of the following is required):
Confirmation of influenza A or B infection in the local community by one of the following means:
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:
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
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):
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.
Vaccination for seasonal influenza on or after August 1, 2015.
Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, peramivir, amantadine or rimantadine within 30 days prior to screening.
Prior treatment with any investigational drug therapy within 30 days prior to screening.
Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
Known sensitivity to nitazoxanide or any of the excipients comprising the nitazoxanide tablets.
Subjects unable to take oral medications.
Subject has chronic kidney or liver disease (including Hepatitis A, B or C) or known impaired hepatic and/or renal function.
Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy.
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.
Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.
Primary purpose
Allocation
Interventional model
Masking
325 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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