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

NCT02057757 | Completed Phase 2 Results DMC

• 1 other identifier: NTZ-SARI
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Severe Acute Respiratory Illness

Outcome Measures

Primary Outcomes (1)

• Time to Hospital Discharge

  The time to hospital discharge measured through Day 28.

  Measured through Day 28

Secondary Outcomes (21)

• Number of Participants Hospitalized on Days 3, 7, 14, and 28

  Measured at Day 3, Day 7, Day 14, and Day 28

• Number of Participants Who Died Within the First 5 Days

  Measured within First 5 Days

• Number of Participants Who Experienced Clinical Symptoms

  Measured through Day 28

• Duration of Fever in Study Participants

  Measured each day through Day 14 and on Day 28

• Number of Participants Who Require Oxygen Use

  Measured through Day 28 or participants' last day of hospitalization

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Nitazoxanide DRUG

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.

Also known as: NTZ

Nitazoxanide (NTZ)

Placebo DRUG

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.

Also known as: PCB

Placebo

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Mexican Emerging Infectious Diseases Clinical Research Network: collaborator

Study Sites (6)

Instituto Nacional de Pediatria

Coyoacán, 04530, Mexico

Location

Hospital General Dr. Aurelio Valdivieso

Oaxaca City, 68050, Mexico

Location

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, 78240, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Tamaulipas, 06720, Mexico

Location

Instituto Nacional de Ciencias medicas y Nutricion Salvador Zubiran

Tlalpan, 14000, Mexico

Location

Instituto Nacional de Enfermedades Respiratorias

Tlalpan, 14000, Mexico

Location

Related Publications (1)

• 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.

  PMID: 30753384 DERIVED

MeSH Terms

Interventions

nitazoxanide

Limitations and Caveats

There were no significant limitations of the study.

Results Point of Contact

• Title: Dr. John Beigel
• Organization: National Institute of Allergy and Infectious Diseases (NIAID)

jbeigel@niaid.nih.gov

301-451-9881

Study Officials

• Lourdes Guerrero Almeida, M.D.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY CHAIR

• Ana Gamiño, M.D.

  Hospital Infantil de Mexico Federico Gomez

  STUDY CHAIR

• Arturo Galindo Fraga, M.D.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• Sarbelio Moreno, M.D.

  Hospital Infantil de Mexico Federico Gomez

  PRINCIPAL INVESTIGATOR

• Javier Araujo Melendez, M.D.

  Hospital Central "Dr. Ignacio Morones Prieto"

  PRINCIPAL INVESTIGATOR

• Alejandra Ramirez Venegas, M.D.

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

• Beatriz Llamosas Gallardo, M.D.

  Instituto Nacional de Pediatria

  PRINCIPAL INVESTIGATOR

• Yuri Roldan Aragon, M.D.

  Hospital General Dr. Aurelio Valdivies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 1, 2018
• Results First Posted: July 31, 2018

Record last verified: 2018-07

Locations

ME (6)