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InfluenzaPhase 2/3NCT01227421

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

A Phase 2/3 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Influenza
What is being tested?
Nitazoxanide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
624 participants
Where
1 siteUnited States
Study dates
Dec 2010to May 2011
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • age 12 to 65 years
  • Presence of clinical signs, respiratory symptoms and constitutional symptoms compatible with influenza infection:
  • fever,
  • at least one of the following respiratory symptoms: cough, sore throat, nasal discharge, nasal congestion, sneezing.
  • 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

Who cannot join

  • severity of illness requiring or anticipated to require in-hospital care
  • High risk of complications from influenza as follows:
  • persons with asthma or other chronic pulmonary diseases
  • persons with hemodynamically significant cardiac disease
  • persons who have immunosuppressive disorders or receiving immunosuppressive therapy
  • persons infected with Human Immunodeficiency Virus (HIV)
Show all 23Show fewer
  • persons with sickle cell anemia or other hemoglobinopathies
  • persons with diseases requiring long-term aspirin therapy
  • persons with chronic renal dysfunction
  • persons with liver disorders
  • Persons with cancer
  • Persons with chronic metabolic disease such as diabetes and inherited mitochondrial disorders
  • Persons with neuromuscular disorders, seizure disorders, or cognitive dysfunction
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Health Sciences Research Center

    Elmira, New York, 14901

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents With Acute Uncomplicated Influenza

This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities.

Read the detailed description

A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza. The primary objectives of this study are to demonstrate the efficacy of nitazoxanide administered 300 mg two times per day for 5 days or 600 mg two times per day for 5 days in reducing the time to resolution of all clinical symptoms of influenza.

The study will also evaluate pharmacokinetics of nitazoxanide in a subset of 24 patients and the safety of the nitazoxanide regimen compared to a placebo via analysis of adverse events and laboratory safety tests.

Blood samples will be collected for all patients at baseline, day 7 and day 28, and for a subset of 24 patients aged 18-65 years (pharmacokinetics subset) on day 2. Urine samples will be collected at baseline and day 7. Nasal swabs will be collected at baseline and day 7 for all patients and on days 2, 3, 4 and 5 for a subset of patients (approximately 20% of patients).

Conditions
Influenza
Being tested
Nitazoxanide, Placebo
Keywords
influenza
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NitazoxanideDrug

    Also called Alinia, NTZ

    Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days

  • NitazoxanideDrug

    Also called Alinia, NTZ

    Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days

  • PlaceboDrug

    Also called Sugar pill

    Tablets, (2 tablets) twice daily with food for 5 days

Study groups in NCT01227421
Study groupRoleWhat they receive
Nitazoxanide, PlaceboActive comparator300 mg nitazoxanide tablet and 1 placebo tablet twice daily for 5 days
Receives: Drug: Nitazoxanide
Nitazoxanide, NitazoxanideActive comparatorTwo 300 mg nitazoxanide tablets(600mg) twice daily for 5 days
Receives: Drug: Nitazoxanide
PlaceboPlacebo comparator2 placebo tablets twice daily for 5 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects

    The primary efficacy analysis for this study was to demonstrate the efficacy of Nitazoxanide (NTZ) administered as 300 mg b.i.d. for 5 days or 600 mg b.i.d. for 5 days in reducing the time to resolution of all clinical symptoms of influenza in patients with laboratory confirmed influenza infection

    Measured: Up to 28 days

Secondary outcomes (14)

  1. Time to Resolution of Each Individual Symptom of Influenza as Reported by the Subjects

    Time in hours (Median and Interquartile range)

    Measured: at least 28 days

  2. Mean Change (Standard Deviation)in 50% Tissue Culture Infective Dose (TCID50) Viral Titer From Baseline

    Change in viral titer presented as logarithm with base 10 (log10) 50% Tissue Culture Infective Dose (TCID50)

    Measured: 7 days

  3. Mean Change in RT-PCR (Reverse Transcription Polymerase Chain Reaction) Viral Titer From Baseline

    Change in viral titer logarithm with base 10 (log10) Ribonucleic Acid (RNA)copies

    Measured: 7 days

  4. Time to Cessation of Viral Shedding Measure by 50% Tissue Culture Infective Dose (TCID50)

    Median time in hours

    Measured: 28 days

  5. Time to Return to Normal Daily Activities

    Time in hours as reported by patient

    Measured: 28 days

  6. Symptom Severity Score Hours

    Sum of the symptom severity score hours from first dose to resolution of symptoms. Patients rated each symptom's severity on a score from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Total symptom severity score hours were calculated by multiplying the sum of the severity scores by duration of symptoms.

    Measured: 28 days

  7. Time Loss From Work

    Time loss from work

    Measured: 28 days

  8. Complications of Influenza

    Proportion of patients with a complication of influenza during the course of the study

    Measured: 28 days

  9. Influenza Antibody Response Titer Change: Influenza A 2009 H1N1

    change in influenza antibody titer for Influenza A 2009 H1N1

    Measured: 28 days

  10. Influenza Antibody Response: Influenza A H3N2

    Change in antibody titer for Influenza A H3N2

    Measured: 28 days

  11. Influenza Antibody Response: Influenza B

    Change in antibody titer for Influenza B

    Measured: 28 days

  12. Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A 2009 H1N1

    Proportion of patients seroprotected or seroconverted at day 28

    Measured: 28 days

  13. Influenza Antibody Response: Seroprotection and Seroconversion for Patients With Influenza A H3N2

    Proportion of patients seroprotected and seroconverted at day 28

    Measured: 28 days

  14. Influenza Antibody Response: Seroprotection and Seroconversion for Influenza B

    Proportion of patients seroprotected and seroconverted at day 28

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionApr 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
624 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01227421
Sponsor's protocol ID
RM08-3001
Status last verified
Sep 2023
First submitted
21 Oct 2010
Last updated
12 Oct 2023
Data monitoring committee
No

Publications

  • Haffizulla J, Hartman A, Hoppers M, Resnick H, Samudrala S, Ginocchio C, Bardin M, Rossignol JF; US Nitazoxanide Influenza Clinical Study Group. Effect of nitazoxanide in adults and adolescents with acute uncomplicated influenza: a double-blind, randomised, placebo-controlled, phase 2b/3 trial. Lancet Infect Dis. 2014 Jul;14(7):609-18. doi: 10.1016/S1473-3099(14)70717-0. Epub 2014 May 19.

    PubMed 24852376

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Resolution of All Clinical Symptoms of Influenza as Reported by the Subjects (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01227421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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