NCT01227421

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
624

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 8, 2014

Completed
Last Updated

October 12, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

October 21, 2010

Results QC Date

May 30, 2012

Last Update Submit

September 28, 2023

Conditions

Influenza

Keywords

influenza

Outcome Measures

Primary Outcomes (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

    Up to 28 days

Secondary Outcomes (14)

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

    at least 28 days

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

    7 days

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

    7 days

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

    28 days

  • Time to Return to Normal Daily Activities

    28 days

  • +9 more secondary outcomes

Study Arms (3)

Nitazoxanide, Placebo

ACTIVE COMPARATOR

300 mg nitazoxanide tablet and 1 placebo tablet twice daily for 5 days

Drug: Nitazoxanide

Nitazoxanide, Nitazoxanide

ACTIVE COMPARATOR

Two 300 mg nitazoxanide tablets(600mg) twice daily for 5 days

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

2 placebo tablets twice daily for 5 days

Drug: Placebo

Interventions

NitazoxanideDRUG

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

Also known as: Alinia, NTZ
Nitazoxanide, Placebo
PlaceboDRUG

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

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Research Center

Elmira, New York, 14901, United States

Location

Related Publications (1)

  • 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.

    PMID: 24852376DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

nitazoxanideSugars

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

Title
Marc Ayers
Organization
Romark Laboratories, L.C.
Marc.Ayers@romark.com
813-282-8544

Study Officials

  • Jean-Francois Rossignol, M.D., Ph.D.

    Romark Laboratories L.C.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 25, 2010

Study Start

December 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

October 12, 2023

Results First Posted

January 8, 2014

Record last verified: 2023-09

Locations

US(1)