Evidence map›Paper›PMID 30753384›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019

Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness.

Ana E Gamiño-Arroyo, M Lourdes Guerrero, Sean McCarthy, Alejandra Ramírez-Venegas, Beatriz Llamosas-Gallardo, Arturo Galindo-Fraga, Sarbelio Moreno-Espinosa, Yuri Roldán-Aragón, Javier Araujo-Meléndez, Sally Hunsberger and 9 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02057757 (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), which is not on this map. Cited by 32 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 5 pooled it
7.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02057757 phase2completednot on this map

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

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2018Enrolled260ConditionsSevere Acute Respiratory IllnessArmsNitazoxanide, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 5 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Influenza Therapeutics in Clinical Practice-Challenges and Recent Advances.Cold Spring Harbor perspectives in medicine · 2021
    Review
  17. Review
  18. Effects of Epigallocatechin-3-Gallate-Palmitate (EC16) onMicrobiology & infectious diseases (Wilmington, Del.) · 2021
    Article
  19. Review
  20. Potential role for nitazoxanide in treating SARS-CoV-2 infection.American journal of physiology. Lung cellular and molecular physiology · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 10 institutions in 2 countries.

Ana E Gamiño-ArroyoHospital Infantil de México "Dr Federico Gómez, Mexico City, Mexico.
M Lourdes GuerreroInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Sean McCarthySocial and Scientific Systems, Inc, Silver Spring, Maryland.
Alejandra Ramírez-VenegasInstituto Nacional de Enfermedades Respiratorias, Mexico City.
Beatriz Llamosas-GallardoInstituto Nacional de Pediatría, Mexico City.
Arturo Galindo-FragaInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Sarbelio Moreno-EspinosaHospital Infantil de México "Dr Federico Gómez, Mexico City, Mexico.
Yuri Roldán-AragónHospital General "Dr Aurelio Valdivieso," Oaxaca, Mexico.
Javier Araujo-MeléndezHospital Central "Dr Ignacio Morones-Prieto," San Luis Potosi, Mexico.
Sally HunsbergerNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Violeta Ibarra-GonzálezInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Julia Martínez-LópezInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Luis A García-AndradeInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Heather KapushocSocial and Scientific Systems, Inc, Silver Spring, Maryland.
H Preston HolleyNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Mary C SmolskisNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Guillermo M Ruiz-PalaciosInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
John H BeigelLeidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Maryland.
Mexico Emerging Infectious Diseases Clinical Research Network (LaRed)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXNational Institutes of Health · USHospital General Dr Aurelio Valdivieso · MXHospital Infantil de México Federico Gómez · MXSocial and Scientific Systems (United States) · USHospital Central Dr. Ignacio Morones Prieto · MXInstituto Nacional de Enfermedades Respiratorias · MXInstituto Nacional de Pediatria · MXLeidos (United States) · USSecretaria de Salud · MX

Funding

CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001ENCI NIH HHS HHSN261201500003CNCI NIH HHS HHSN261201500003I
6 · The paper itself

Abstract

backgroundEffective therapeutics for respiratory viruses are needed. Early data suggest that nitazoxanide (NTZ) may be beneficial for treating acute respiratory viral illness.

methodsFrom March 2014 through March 2017, a double-blind, placebo-controlled trial was conducted in 260 participants ≥1 year old hospitalized with influenza-like illness at 6 hospitals in Mexico. Participants were randomized 1:1 to NTZ (age ≥12 years, 600 mg twice daily; age 4-11 years and 1-3 years, 200 or 100 mg twice daily, respectively) or placebo for 5 days in addition to standard of care. The primary endpoint was time from first dose to hospital discharge. Influenza reverse-transcription polymerase chain reaction and Respifinder 22 multiplex test were used for virus detection.

resultsOf 260 participants enrolled, 257 were randomized and took at least 1 dose of study treatment (intention-to-treat population): 130 in the NTZ group and 127 in the placebo group. The Kaplan-Meier estimate of the median duration of hospitalization was 6.5 (interquartile range [IQR], 4.0-9.0) days in the NTZ group vs 7.0 (IQR, 4.0-9.0) days in the placebo group (P = .56). Duration of hospitalization between the 2 treatments was similar in children (P = .29) and adults (P = .62), influenza A and B (P = .32), and other respiratory viruses. Seven (5.4%) and 6 (4.7%) participants in the NTZ and placebo groups, respectively, reported serious adverse events.

conclusionsTreatment with NTZ did not reduce the duration of hospital stay in severe influenza-like illness. Further analyses based on age and evaluations by virus did not reveal any subgroups that appeared to benefit from NTZ. CLINICAL TRIALS REGISTRATION: NCT02057757.

Indexed as

AdolescentAdultAgedAntiviral AgentsChildChild, PreschoolDouble-Blind MethodFemaleHospitalizationHumansKaplan-Meier EstimateMaleMiddle AgedNitro CompoundsOseltamivirSevere Acute Respiratory SyndromeAntiviral AgentsnitazoxanideNitro CompoundsOseltamivirThiazolesZanamivirhospitalizedinfluenza-like illnessnitazoxaniderespiratory virus

Identifiers

PMID30753384
PMCPMC6853643
OpenAlexW2913747529

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.