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Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

This study has been terminated.
(Insufficient enrollment during 2009-2010 flu season, new study initiated.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056380
First Posted: January 26, 2010
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Romark Laboratories L.C.
January 23, 2010
January 26, 2010
November 18, 2013
August 8, 2017
August 8, 2017
January 2010
December 2010   (Final data collection date for primary outcome measure)
Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection) [ Time Frame: Up to 28 days ]
Same as current
Complete list of historical versions of study NCT01056380 on ClinicalTrials.gov Archive Site
  • Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus) [ Time Frame: Up to 28 days ]
  • Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects) [ Time Frame: Up to 28 days ]
  • Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza) [ Time Frame: Up to 28 days ]
  • Severity of Disease Expressed in Score-hours (Symptom Scores Multiplied by Duration of Symptoms in Hours) [ Time Frame: Up to 28 days ]
    Subjects recorded symptom severity as absent, mild, moderate, or severe (0-3, respectively) twice daily for at least seven days. The average severity score for each symptom was multiplied by the duration of the time period to which the score applied to arrive at score-hours for that period. For example, if a symptom was graded as '2' at 8:00 AM and '1' at 8:30 PM of the same day, the average score for that time period was 1.5, the time period was 12.5 hours, and the calculated number of score-hours for that period was 18.75. The score-hours for each time period were added and divided by the total number of hours.
  • Time Lost From Work (Subjects With Confirmed Influenza) [ Time Frame: Up to 28 days ]
  • Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza) [ Time Frame: Up to 28 days ]
  • Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza) [ Time Frame: 28 days ]
  • Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) [ Time Frame: 4 days ]
  • Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus) [ Time Frame: Up to 28 days ]
  • Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects) [ Time Frame: Up to 28 days ]
  • Time to return to normal daily activity (subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ]
  • Severity of disease expressed in score-hours (symptom scores multiplied by duration of symptoms for subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ]
  • Time lost from work (subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ]
  • Complications of influenza including secondary illnesses, antibiotic use and hospitalizations (subjects with confirmed influenza, subjects any respiratory virus and all treated subjects) [ Time Frame: Up to 28 days ]
  • Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza) [ Time Frame: 7 days ]
  • Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) [ Time Frame: 7 days ]
Not Provided
Not Provided
 
Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Influenza
  • Drug: Nitazoxanide
    Tablet, 500 mg with food twice daily for 5 days
    Other Name: Alinia, NTZ
  • Drug: Placebo
    Tablet, twice daily with food for 5 days
    Other Name: Sugar pill
  • Active Comparator: Nitazoxanide
    Intervention: Drug: Nitazoxanide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
79
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01056380
RM01-2027
No
Not Provided
Not Provided
Romark Laboratories L.C.
Romark Laboratories L.C.
Not Provided
Study Chair: Jean-François Rossignol, MD, PhD The Romark Institute for Medical Research
Romark Laboratories L.C.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP