NCT01056380

Brief Summary

This is a randomized clinical trial designed to evaluate oral nitazoxanide compared to a placebo in the treatment of acute uncomplicated influenza in adults. We hypothesize that treatment with nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, we 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, and viral shedding.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

August 8, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

January 23, 2010

Results QC Date

November 18, 2013

Last Update Submit

April 3, 2018

Conditions

Influenza

Keywords

influenzainfluenza like illness

Outcome Measures

Primary Outcomes (1)

  • Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)

    Up to 28 days

Secondary Outcomes (8)

  • Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)

    Up to 28 days

  • Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)

    Up to 28 days

  • Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)

    Up to 28 days

  • Overall Severity of Disease Score

    Up to 14 days

  • Time Lost From Work (Subjects With Confirmed Influenza)

    Up to 28 days

  • +3 more secondary outcomes

Study Arms (2)

Nitazoxanide

ACTIVE COMPARATOR
Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NitazoxanideDRUG

Tablet, 500 mg with food twice daily for 5 days

Also known as: Alinia, NTZ
Nitazoxanide
PlaceboDRUG

Tablet, twice daily with food for 5 days

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65 years
  • Fever, respiratory symptoms and constitutional symptoms compatible with influenza infection
  • Influenza A or B infection in the local community
  • Onset of illness no more than 48 hours before presentation
  • Willing and able to provide comply with protocol requirements

You may not qualify if:

  • Severity of illness requiring or anticipated to require in-hospital care
  • High risk of complications from influenza per IDSA (Infectious Diseases Society of America) guidelines or current CDC (Centers for Disease Control) criteria
  • Females pregnant, breast-feeding or sexually active without birth control
  • Vaccination for seasonal influenza or H1N1 on or after August 1, 2009
  • Treatment with antiviral medication for influenza within 1 month prior to screening
  • Treatment with nitazoxanide or any investigational drug within 1 month prior to screening
  • Known sensitivity to nitazoxanide or any excipients
  • Unable to take oral medications
  • Chronic kidney or liver disease or known impaired hepatic and/or renal function
  • Other pre-existing chronic infection undergoing or requiring medical therapy
  • Pre-existing illness placing subject at unreasonably increased risk by participation in study
  • Unlikely to comply with the requirements of this protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Research Center at Asthma and Allergy Associates, P.C.

Elmira, New York, 14901, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

nitazoxanideSugars

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

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

Study Officials

  • Jean-François Rossignol, MD, PhD

    The Romark Institute for Medical Research

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

January 23, 2010

First Posted

January 26, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 5, 2018

Results First Posted

August 8, 2017

Record last verified: 2018-04

Locations

US(1)