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Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Primary Purpose

Influenza

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Sponsored by
Romark Laboratories L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring influenza, influenza like illness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nitazoxanide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)
Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)
Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)
Overall Severity of Disease Score
Subjects recorded a severity score for 10 flu symptoms on a 0-3 scale BID for 7-14 days.The severity score for each symptom was multiplied by the number of hours scored at that severity for the entire time the subject maintained a diary (a sneezing score of 1 for 12 hours and 0 for 10 hours =1*12 + 0*10=12). This is symptom severity score*hours.Symptom severity score*hours for each of the symptoms were added for an overall symptom severity score*hours (if symptom severity score*hours for 10 symptoms were 12, 10, 9, 8, 7, 10, 10, 10, 5, 5, overall symptom severity score*hours=86).Overall symptom severity score*hours were divided by the number of hours that the subject kept a diary for a standardized continuous measure of severity of the course of illness (if overall symptom severity score*hours=86 and the subject maintained a diary for 100 hours Overall Severity of Disease Score=0.86). Overall Severity of Disease Score can range 0-30 with higher scores indicating more severe symptoms.
Time Lost From Work (Subjects With Confirmed Influenza)
Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)
Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)
Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza)

Full Information

First Posted
January 23, 2010
Last Updated
April 3, 2018
Sponsor
Romark Laboratories L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT01056380
Brief Title
Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment during 2009-2010 flu season, new study initiated.
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Romark Laboratories L.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study is conducted at approximately 25 sites in the United States. Subjects selected based on symptoms will be randomized to receive oral nitazoxanide or placebo twice daily for 5 days. Subjects will be monitored by daily by telephone or home visit to monitor symptoms and complications of influenza for safety and will be referred for medical care as required. Subjects will complete a diary twice daily to record the presence and severity of symptoms, ability to perform normal daily activities and time lost from work. Complications of influenza (including sinusitis, otitis, bronchitis, pneumonia, central nervous system disease) and other adverse events will be reported. Nasopharyngeal swabs will be collected at Baseline (Day 0) and Day 7 for all patients and on Days 1 through 4 for a subset of patients to test for influenza A (including novel H1N1), influenza B and 17 other respiratory viruses by RT-PCR and culture and to evaluate quantitative viral shedding. The primary analysis will be for patients with confirmed influenza, and secondary analyses will be conducted for subjects with any respiratory virus and for all treated subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, influenza like illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitazoxanide
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alinia, NTZ
Intervention Description
Tablet, 500 mg with food twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Tablet, twice daily with food for 5 days
Primary Outcome Measure Information:
Title
Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)
Time Frame
Up to 28 days
Title
Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)
Time Frame
Up to 28 days
Title
Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)
Time Frame
Up to 28 days
Title
Overall Severity of Disease Score
Description
Subjects recorded a severity score for 10 flu symptoms on a 0-3 scale BID for 7-14 days.The severity score for each symptom was multiplied by the number of hours scored at that severity for the entire time the subject maintained a diary (a sneezing score of 1 for 12 hours and 0 for 10 hours =1*12 + 0*10=12). This is symptom severity score*hours.Symptom severity score*hours for each of the symptoms were added for an overall symptom severity score*hours (if symptom severity score*hours for 10 symptoms were 12, 10, 9, 8, 7, 10, 10, 10, 5, 5, overall symptom severity score*hours=86).Overall symptom severity score*hours were divided by the number of hours that the subject kept a diary for a standardized continuous measure of severity of the course of illness (if overall symptom severity score*hours=86 and the subject maintained a diary for 100 hours Overall Severity of Disease Score=0.86). Overall Severity of Disease Score can range 0-30 with higher scores indicating more severe symptoms.
Time Frame
Up to 14 days
Title
Time Lost From Work (Subjects With Confirmed Influenza)
Time Frame
Up to 28 days
Title
Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)
Time Frame
Up to 28 days
Title
Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)
Time Frame
28 days
Title
Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza)
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François Rossignol, MD, PhD
Organizational Affiliation
The Romark Institute for Medical Research
Official's Role
Study Chair
Facility Information:
Facility Name
Health Sciences Research Center at Asthma and Allergy Associates, P.C.
City
Elmira
State/Province
New York
ZIP/Postal Code
14901
Country
United States

12. IPD Sharing Statement

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Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

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