InfluenzaPhase 2NCT01056380
Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
A Phase 2 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Sciences Research Center at Asthma and Allergy Associates, P.C.
Elmira, New York, 14901
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Nitazoxanide, Placebo
- Keywords
- influenza, influenza like illness
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia, NTZ
Tablet, 500 mg with food twice daily for 5 days
PlaceboDrug
Also called Sugar pill
Tablet, twice daily with food for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Active comparator | Not described Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)
Measured: Up to 28 days
Secondary outcomes (8)
Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)
Measured: Up to 28 days
Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)
Measured: Up to 28 days
Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)
Measured: Up to 28 days
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.
Measured: Up to 14 days
Time Lost From Work (Subjects With Confirmed Influenza)
Measured: Up to 28 days
Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)
Measured: Up to 28 days
Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)
Measured: 28 days
Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Insufficient enrollment during 2009-2010 flu season, new study initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-François Rossignol, MD, PhD, Study chair, The Romark Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056380
- Sponsor's protocol ID
- RM01-2027
- Status last verified
- Apr 2018
- First submitted
- 23 Jan 2010
- Last updated
- 5 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT01056380
- Acronym / sponsor ID
- RM01-2027
- Conditions
- Influenza
- Keywords
- influenza, influenza like illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment during 2009-2010 flu season, new study initiated.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 8 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Active comparator | Drug: Nitazoxanide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: Alinia, NTZTablet, 500 mg with food twice daily for 5 days | Drug | Nitazoxanide |
| PlaceboAlso: Sugar pillTablet, twice daily with food for 5 days | Drug | Placebo |
Primary outcome
Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)
Time frame: Up to 28 days
8 secondary outcomes
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
Overall Severity of Disease Score
Time frame: Up to 14 days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Rossignol, MD, PhD study chair
The Romark Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.