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Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

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ClinicalTrials.gov Identifier: NCT01056380
Recruitment Status : Terminated (Insufficient enrollment during 2009-2010 flu season, new study initiated.)
First Posted : January 26, 2010
Results First Posted : August 8, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Nitazoxanide Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Nitazoxanide Drug: Nitazoxanide
Tablet, 500 mg with food twice daily for 5 days
Other Name: Alinia, NTZ

Placebo Comparator: Placebo Drug: Placebo
Tablet, twice daily with food for 5 days
Other Name: Sugar pill




Primary Outcome Measures :
  1. Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection) [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus) [ Time Frame: Up to 28 days ]
  2. Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects) [ Time Frame: Up to 28 days ]
  3. Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza) [ Time Frame: Up to 28 days ]
  4. Overall Severity of Disease Score [ Time Frame: Up to 14 days ]
    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.

  5. Time Lost From Work (Subjects With Confirmed Influenza) [ Time Frame: Up to 28 days ]
  6. Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza) [ Time Frame: Up to 28 days ]
  7. Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza) [ Time Frame: 28 days ]
  8. Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) [ Time Frame: 4 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056380


Locations
United States, New York
Health Sciences Research Center at Asthma and Allergy Associates, P.C.
Elmira, New York, United States, 14901
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
Study Chair: Jean-François Rossignol, MD, PhD The Romark Institute for Medical Research

Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT01056380     History of Changes
Other Study ID Numbers: RM01-2027
First Posted: January 26, 2010    Key Record Dates
Results First Posted: August 8, 2017
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Romark Laboratories L.C.:
influenza
influenza like illness

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents