Trial Outcomes & Findings for Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza (NCT NCT01056380)

NCT ID: NCT01056380

Last Updated: 2018-04-05

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 79 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2018-04-05

Participant Flow

Patients were enrolled at 11 primary care health centers throughout the United States in the last months of the 2009/2010 flu season

Participant milestones

Measure	Nitazoxanide Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo Placebo : Tablet, twice daily with food for 5 days
Overall Study STARTED	37	42
Overall Study COMPLETED	35	39
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Nitazoxanide Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo Placebo : Tablet, twice daily with food for 5 days
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Baseline characteristics by cohort

Measure	Nitazoxanide n=37 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=42 Participants Placebo : Tablet, twice daily with food for 5 days	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	42 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.6 years STANDARD_DEVIATION 14.4 • n=5 Participants	37.9 years STANDARD_DEVIATION 13.3 • n=7 Participants	38.2 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	42 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: All subjects with laboratory confirmed influenza who took at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=3 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=3 Participants Placebo : Tablet, twice daily with food for 5 days
Time to Resolution of All Clinical Symptoms of Influenza (Subjects With Confirmed Influenza Infection)	55.0 hours Interval 12.0 to 176.0	91.5 hours Interval 70.0 to 178.0

SECONDARY outcome

Timeframe: Up to 28 days

Population: All subjects with any laboratory confirmed viral infection who took at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=20 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=22 Participants Placebo : Tablet, twice daily with food for 5 days
Time to Resolution of All Clinical Symptoms of Influenza (Subjects Infected With Any Respiratory Virus)	118.0 hours Interval 80.0 to 157.0	88.8 hours Interval 70.0 to 139.0

SECONDARY outcome

Timeframe: Up to 28 days

Population: All subjects who received at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=37 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=40 Participants Placebo : Tablet, twice daily with food for 5 days
Time to Resolution of All Clinical Symptoms of Influenza (All Treated Subjects)	119.8 hours Interval 72.0 to 169.0	102.6 hours Interval 69.0 to 141.0

SECONDARY outcome

Timeframe: Up to 28 days

Population: All subjects with laboratory confirmed influenza who received at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=3 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=3 Participants Placebo : Tablet, twice daily with food for 5 days
Time to Return to Normal Daily Activity (Subjects With Confirmed Influenza)	48.5 hours Interval 31.0 to 176.0	57.5 hours Interval 21.0 to 128.0

SECONDARY outcome

Timeframe: Up to 14 days

Population: All subjects with laboratory confirmed influenza who received at least one dose of study medication.

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.

Outcome measures

Measure	Nitazoxanide n=3 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=3 Participants Placebo : Tablet, twice daily with food for 5 days
Overall Severity of Disease Score	5.4 overall severity score Standard Deviation 3.3	6.2 overall severity score Standard Deviation 3.6

SECONDARY outcome

Timeframe: Up to 28 days

Population: All subjects with laboratory confirmed influenza who received at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=3 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=3 Participants Placebo : Tablet, twice daily with food for 5 days
Time Lost From Work (Subjects With Confirmed Influenza)	3.64 hours Interval -0.04 to 7.32	4.36 hours Interval -0.7 to 9.42

SECONDARY outcome

Timeframe: Up to 28 days

Population: All subjects with laboratory confirmed influenza who received at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=3 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=3 Participants Placebo : Tablet, twice daily with food for 5 days
Complications of Influenza Including Secondary Illnesses, Antibiotic Use and Hospitalizations (Subjects With Confirmed Influenza)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=1 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=2 Participants Placebo : Tablet, twice daily with food for 5 days
Time to Cessation of Viral Shedding (Subjects With Confirmed Influenza)	95.5 hours Interval 95.5 to 95.5	83.3 hours Interval 72.0 to 95.0

SECONDARY outcome

Timeframe: 4 days

Population: All subjects with laboratory confirmed influenza enrolled in the intensive virologic follow up substudy who received at least one dose of study medication.

Outcome measures

Measure	Nitazoxanide n=1 Participants Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=2 Participants Placebo : Tablet, twice daily with food for 5 days
Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) Baseline	0 Quantitative PCR RNA Copies Standard Deviation 0	0 Quantitative PCR RNA Copies Standard Deviation 0
Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) Day 2	0 Quantitative PCR RNA Copies Standard Deviation 0	-175183057 Quantitative PCR RNA Copies Standard Deviation 373069697
Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) Day 3	0 Quantitative PCR RNA Copies Standard Deviation 0	-176973304 Quantitative PCR RNA Copies Standard Deviation 374681622
Change in Influenza Virus Titer Assessed by Quantitative RT-PCR (Subjects With Confirmed Influenza) Day 4	0 Quantitative PCR RNA Copies Standard Deviation 0	-176946354 Quantitative PCR RNA Copies Standard Deviation 375523235

Adverse Events

Nitazoxanide

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nitazoxanide n=37 participants at risk Nitazoxanide : Tablet, 500 mg with food twice daily for 5 days	Placebo n=42 participants at risk Placebo : Tablet, twice daily with food for 5 days
Gastrointestinal disorders Gastrointestinal disorders	5.4% 2/37 • Number of events 3	9.5% 4/42 • Number of events 5
General disorders General disorders and administration site conditions	2.7% 1/37 • Number of events 1	2.4% 1/42 • Number of events 1
Ear and labyrinth disorders Infections and infestations	5.4% 2/37 • Number of events 2	4.8% 2/42 • Number of events 3
Musculoskeletal and connective tissue disorders Muscoloskeletal and connective tissue disorders	2.7% 1/37 • Number of events 1	0.00% 0/42
Nervous system disorders Nervous system disorders	2.7% 1/37 • Number of events 1	4.8% 2/42 • Number of events 2
Renal and urinary disorders Renal and urinary disorders	8.1% 3/37 • Number of events 3	0.00% 0/42
Reproductive system and breast disorders Reproductive system and breast disorders	2.7% 1/37 • Number of events 1	0.00% 0/42
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	8.1% 3/37 • Number of events 3	4.8% 2/42 • Number of events 2

Additional Information

Marc Ayers

Romark Laboratories, L.C.

Phone: 813-282-8544

Email: Marc.Ayers@romark.com

Results disclosure agreements

• Principal investigator is a sponsor employee Presentation and/or publication is encouraged provided the Sponsor is notified in advance and given the opportunity to review the manuscript or abstract 30 days prior to its submission for presentation at a scientific meeting or for publication in a scientific journal. The investigators will have complete autonomy regarding the content and wording including the decision of whether or not to publish.
• Publication restrictions are in place

Restriction type: OTHER