Severe Acute Respiratory IllnessPhase 2NTZ-SARINCT02057757

Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness

A Phase 2 study testing Nitazoxanide in people with Severe Acute Respiratory Illness, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Respiratory viruses are a significant cause of hospitalization for respiratory tract infections. This study will evaluate the safety, effectiveness, and tolerability of nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are hospitalized. Read more about this study

Who is it for?: Ages 12 months and older
Conditions the study is for: Severe Acute Respiratory Illness
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: 260 participants
Where: 6 sitesMexico
Study dates: Feb 2014to Jan 2018
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 12 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Signed informed consent prior to performance or initiation of any study procedures
Age greater than or equal to 12 months of age (no upper age limit)
Influenza-like illness (ILI), defined as (all of the following):
Onset of fever greater than or equal to 38°C (or hypothermia less than 36°C)
New or worse cough or sore throat
New or worse shortness of breath or difficulty breathing

Show all 11Show fewer

Onset of illness no more than 5 days before screening defined as when the participant experienced at least 1 respiratory symptom, constitutional symptom, or fever
Hospitalization for ILI (decision for hospitalization will be up to the individual treating clinician), with anticipated hospitalization for more than 24 hours
One of the following to avoid pregnancy:
Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 1 effective form of contraception from the date of informed consent through Day 28 of study
Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms or have a partner use at least 1 effective form of contraception through Day 28 of study

Who cannot join

Women who are pregnant or breastfeeding
Clinical suspicion that etiology of illness is primarily bacterial in origin
Prior treatment with antivirals (e.g., oseltamivir) for the current illness for more than 24 hours
Unable to take oral medications (adults must tolerate tablets, children must tolerate suspension)
Unable to tolerate oral food/fluids (absorption is significantly better with food)
Prior treatment with any investigational drug therapy within 30 days prior to screening

Show all 17Show fewer

Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets
Prior NTZ use within 1 week
Self-reported history of chronic kidney disease or impaired renal function (no blood or urine kidney function laboratory testing will be done prior to enrollment, but intent is to exclude disease severe enough to cause estimated creatinine clearance [CrCl] less than 30)
Self-reported history of liver disease (no blood laboratory testing will be done prior to enrollment, but intent is to exclude disease severe enough to cause cirrhosis or total bilirubin greater than 2, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] greater than 3 times the upper limit of normal [ULN])
Presence of any pre-existing illness that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study
Participants who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
The onset of SARI occurs after hospitalization
Hospitalized for any reason for greater than 48 hours prior to enrollment
Participants previously enrolled in this study
Prior hospital discharge within 30 days
Known chronic respiratory infection (e.g., tuberculosis, atypical mycobacterial infections)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Mexico6 sites

Instituto Nacional de Pediatria
Coyoacán, 04530
Hospital General Dr. Aurelio Valdivieso
Oaxaca City, 68050
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, 78240
Hospital Infantil de Mexico Federico Gomez
Tamaulipas, 06720
Instituto Nacional de Ciencias medicas y Nutricion Salvador Zubiran
Tlalpan, 14000
Instituto Nacional de Enfermedades Respiratorias
Tlalpan, 14000

Other trials in Mexico

About this study

Official title: A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Nitazoxanide Versus Placebo in Addition to Standard Care for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness

Read the detailed description

Respiratory viral infections are one of the most common causes of illness in the world. These infections are major causes of SARI and can lead to severe outcomes, including hospitalization and death. NTZ is a medication that is approved in the United States and Mexico to treat gastrointestinal parasitic diseases. This study will evaluate the use of NTZ to treat SARI. The purpose of this study is to evaluate the safety, effectiveness, and tolerability of NTZ, in combination with standard care, in treating SARI in people who are hospitalized.

Participants will be hospitalized and study entry assessments will include medical assessments, blood collection, and a nasopharyngeal swab or wash. Participants will then be randomly assigned to receive NTZ or placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ or placebo; participants 12 years and older will receive NTZ or placebo tablets. All participants will also receive standard of care treatment for acute severe viral respiratory infections, which may include antibiotics and/or treatment for influenza. They will be discharged from the hospital based on their doctors' recommendations. Participants will record their temperature and symptoms in a daily diary, which will be reviewed by study staff during study visits. Follow-up visits will occur on Days 3, 7, 14, and 28, and may occur as inpatient or outpatient visits. These visits may include the same assessments that occurred at baseline, as well as physical examinations, depending on the visit. Participants who are still hospitalized at Day 28 will be followed by study staff until they are discharged from the hospital.

Conditions: Severe Acute Respiratory Illness
Being tested: Nitazoxanide, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NitazoxanideDrug
Also called NTZ
Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.
Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.
Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.
PlaceboDrug
Also called PCB
Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.
Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.
Participants 12 years and older: two placebo tablets orally twice daily for 5 days.

Study groups in NCT02057757
Study group	Role	What they receive
Nitazoxanide (NTZ)	Experimental	Participants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets. Receives: Drug: Nitazoxanide
Placebo	Placebo comparator	Participants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Hospital Discharge
The time to hospital discharge measured through Day 28.
Measured: Measured through Day 28

Secondary outcomes (21)

Number of Participants Hospitalized on Days 3, 7, 14, and 28
The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.
Measured: Measured at Day 3, Day 7, Day 14, and Day 28
Number of Participants Who Died Within the First 5 Days
Total Deaths of Participants, including Deaths within First 5 Days
Measured: Measured within First 5 Days
Number of Participants Who Experienced Clinical Symptoms
Measured daily through Study Day 14 and then again on Study Day 28
Measured: Measured through Day 28
Duration of Fever in Study Participants
Study participants' duration (hours) of fever measured daily through Day 14 and then again on Day 28. The total duration in hours from the visit when fever was registered for the study participant until the next visit when no fever was registered for the study participant.
Measured: Measured each day through Day 14 and on Day 28
Number of Participants Who Require Oxygen Use
Number of study participants who require use of supplemental oxygen at time points (e.g., Any time, Day 0, Day 3, Day 7, Day 14, and Day 28)
Measured: Measured through Day 28 or participants' last day of hospitalization
Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28)
Number of study participants (e.g., adult and children) admitted to the intensive care unit (ICU) by time point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.
Measured: Measured through Day 28 or participants' last day in the ICU
Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28)
Study participants (e.g., adults, children) requiring mechanical ventilation (e.g., intubation/extubation) at study time points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.
Measured: Measured through Day 28 or participants' last day of hospitalization
Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study
Number of study participants (e.g., adults and children) with the presence of a complication (pneumonia, respiratory failure requiring mechanical ventilation, acute respiratory distress syndrome [ARDS], sepsis, or bronchiolitis) during the study .
Measured: Measured through Day 28 or participants' last day of hospitalization
Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)
Study participant (e.g., adults and children) answers (e.g., yes) to global assessment questions measured daily through Day 14 and then again on Day 28.
Measured: Measured daily through Day 14 and on Day 28
Number of Participants Using Antibiotics/Antivirals During Hospitalization
Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.
Measured: Measured through participants' first 5 days of hospitalization
Number of Participants Who Are Re-hospitalized Within 28 Days
Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).
Measured: Measured through Day 28
Use of Systemic Corticosteroids
Number of study participants taking Systemic Steroids during first 5 days.
Measured: Measured within First 5 Days
Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)
Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.
Measured: Measured through Day 3
Number of Participants Reporting Adverse Events (AEs)
Number of study participants with at least one Adverse Event During Study Duration
Measured: Measured through Day 28 or participants' last day of hospitalization
Number of Participants Reporting Serious Adverse Events (SAEs)
Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).
Measured: Measured through Day 28 or participants' last day of hospitalization
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.
Measured: Measured on Day 3, Day, 7 and Day 28
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.
Measured: Measured on Day 3, Day 7, and Day 28
Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28
Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.
Measured: Measured on Day 3, Day, 7 and Day 28
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.
Measured: Measured on Day 3, Day, 7 and Day 28
Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28
Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.
Measured: Measured on Day 3, Day, 7 and Day 28
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.
Measured: Measured on Day 3, Day, 7 and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jan 2018

First posted7 Feb 2014 (estimated)
Study startFeb 2014
Primary completionMay 2017
Study completionJan 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Severe Acute Respiratory IllnessStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
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: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02057757
Sponsor's protocol ID: NTZ-SARI
Acronym: NTZ-SARI
Status last verified: Jul 2018
First submitted: 5 Feb 2014
Last updated: 1 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Gamino-Arroyo AE, Guerrero ML, McCarthy S, Ramirez-Venegas A, Llamosas-Gallardo B, Galindo-Fraga A, Moreno-Espinosa S, Roldan-Aragon Y, Araujo-Melendez J, Hunsberger S, Ibarra-Gonzalez V, Martinez-Lopez J, Garcia-Andrade LA, Kapushoc H, Holley HP, Smolskis MC, Ruiz-Palacios GM, Beigel JH; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed). Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness. Clin Infect Dis. 2019 Nov 13;69(11):1903-1911. doi: 10.1093/cid/ciz100.
PubMed 30753384

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Nitazoxanide Versus Placebo in Addition to Standard Care for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness
ClinicalTrials.gov ID: NCT02057757
Acronym / sponsor ID: NTZ-SARI / NTZ-SARI
Conditions: Severe Acute Respiratory Illness
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Mexican Emerging Infectious Diseases Clinical Research Network
Study start: Feb 2014
Primary completion: May 2017 (actual)
Study completion: Jan 2018 (actual)
First posted: 7 Feb 2014 (estimated)
Results: Posted 31 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 (NTZ)	Experimental	Drug: NitazoxanideParticipants will receive NTZ for 5 days. Participants younger than 12 years will receive an oral suspension formulation of NTZ; participants 12 years and older will receive NTZ tablets.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo for 5 days. Participants younger than 12 years will receive an oral suspension formulation of placebo; participants 12 years and older will receive placebo tablets.

Who may qualify

Ages: 12 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Signed informed consent prior to performance or initiation of any study procedures
Age greater than or equal to 12 months of age (no upper age limit)
Influenza-like illness (ILI), defined as (all of the following):
Onset of illness no more than 5 days before screening defined as when the participant experienced at least 1 respiratory symptom, constitutional symptom, or fever
Hospitalization for ILI (decision for hospitalization will be up to the individual treating clinician), with anticipated hospitalization for more than 24 hours

Key exclusion criteria (17 listed)

Women who are pregnant or breastfeeding
Clinical suspicion that etiology of illness is primarily bacterial in origin
Prior treatment with antivirals (e.g., oseltamivir) for the current illness for more than 24 hours
Unable to take oral medications (adults must tolerate tablets, children must tolerate suspension)
Unable to tolerate oral food/fluids (absorption is significantly better with food)

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: NTZParticipants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days. Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days.	Drug	Nitazoxanide (NTZ)
PlaceboAlso: PCBParticipants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days. Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days. Participants 12 years and older: two placebo tablets orally twice daily for 5 days.	Drug	Placebo

Primary outcome

Time to Hospital Discharge
Time frame: Measured through Day 28
The time to hospital discharge measured through Day 28.

21 secondary outcomes

Number of Participants Hospitalized on Days 3, 7, 14, and 28
Time frame: Measured at Day 3, Day 7, Day 14, and Day 28
Number of Participants Who Died Within the First 5 Days
Time frame: Measured within First 5 Days
Number of Participants Who Experienced Clinical Symptoms
Time frame: Measured through Day 28
Duration of Fever in Study Participants
Time frame: Measured each day through Day 14 and on Day 28
Number of Participants Who Require Oxygen Use
Time frame: Measured through Day 28 or participants' last day of hospitalization
Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28)
Time frame: Measured through Day 28 or participants' last day in the ICU
Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28)
Time frame: Measured through Day 28 or participants' last day of hospitalization
Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study
Time frame: Measured through Day 28 or participants' last day of hospitalization
Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)
Time frame: Measured daily through Day 14 and on Day 28
Number of Participants Using Antibiotics/Antivirals During Hospitalization
Time frame: Measured through participants' first 5 days of hospitalization
Number of Participants Who Are Re-hospitalized Within 28 Days
Time frame: Measured through Day 28
Use of Systemic Corticosteroids
Time frame: Measured within First 5 Days
Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)
Time frame: Measured through Day 3
Number of Participants Reporting Adverse Events (AEs)
Time frame: Measured through Day 28 or participants' last day of hospitalization
Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: Measured through Day 28 or participants' last day of hospitalization
Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28
Time frame: Measured on Day 3, Day, 7 and Day 28
Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28
Time frame: Measured on Day 3, Day 7, and Day 28
Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28
Time frame: Measured on Day 3, Day, 7 and Day 28
Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28
Time frame: Measured on Day 3, Day, 7 and Day 28
Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28
Time frame: Measured on Day 3, Day, 7 and Day 28
Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28
Time frame: Measured on Day 3, Day, 7 and Day 28

Results and safety

Results posted to the registry on 31 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nitazoxanide (NTZ)	131	117
Placebo	129	121

Primary outcome: Time to Hospital Discharge

Time frame: Measured through Day 28. Mean (Standard Error). Unit: Days

Measure	Nitazoxanide (NTZ) n = 130	Placebo n = 127
Value	7.1 (0.37)	7.5 (0.41)

Nitazoxanide (NTZ) vs Placebo: p = 0.5634, Fay - Shaw

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were recorded for each subject starting at completing the Informed Consent process and continuing until the subject completed study, or until resolution of the adverse event as recorded by the clinical site (up to Day 28).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nitazoxanide (NTZ)	6 of 130 (4.6%)	26 of 130 (20%)	2 of 130
Placebo	3 of 127 (2.4%)	26 of 127 (20.5%)	1 of 127

Limitations and caveats (from the sponsor): There were no significant limitations of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30753384Gamino-Arroyo AE, Guerrero ML, McCarthy S, Ramirez-Venegas A, Llamosas-Gallardo B, Galindo-Fraga A, Moreno-Espinosa S, Roldan-Aragon Y, Araujo-Melendez J, Hunsberger S, Ibarra-Gonzalez V, Martinez-Lopez J, Garcia-Andrade LA, Kapushoc H, Holley HP, Smolskis MC, Ruiz-Palacios GM, Beigel JH; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed). Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness. Clin Infect Dis. 2019 Nov 13;69(11):1903-1911. doi: 10.1093/cid/ciz100.
Individual participant dataSharing planned: Undecided

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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.

Lourdes Guerrero Almeida, M.D. study chair

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Ana Gamiño, M.D. study chair

Hospital Infantil de Mexico Federico Gomez

Arturo Galindo Fraga, M.D. principal investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

6 sites 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 Severe Acute Respiratory Illness, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in Mexico.

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 11 inclusion and 17 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: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Mexico. 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 31 Jul 2018). 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 Hospital Discharge (time frame: Measured through Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02057757, which also lists 1 linked publication.

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 1 Aug 2018.