Influenza-like IllnessNCT01418287
Characterization of Influenza-like Illness in Mexico
An observational study of Influenza-like Illness, run by Mexican Emerging Infectious Diseases Clinical Research Network at 6 sites in Mexico.
Trial summary
A study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with H1N1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza-like Illness
- How many people
- 5,819 participants
- Where
- 6 sitesMexico
- Study dates
- Apr 2010to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with influenza-like illness presenting to clinical sites in Mexico
Who may be able to join
- Signed informed consent by participant, or for pediatric participants, signed informed consent by parent/legal guardian and, where appropriate, signed assent by participant
- At least one respiratory symptom (e.g., shortness of breath, postnasal drip, cough) and
- One of the following criteria:
- Fever (≥ 38 °C by any method: oral, axillary, etc.) on examination or participant-reported fever (≥ 38° C) or feverishness in the past 24 hours
- One or more non-respiratory symptoms (e.g., malaise, headache, myalgia,chest pain)
- Consenting to provide aspirate or naso-pharyngeal swab
Who cannot join
- The onset of illness is more than 48 hours after hospitalization.
- Participants previously included in this study within the last 30 days.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Mexico6 sites
Instituto Nacional de Pediatría (INP)
México, State of Mexico, CP 04530
Hospital Infantil de México Federico Gómez (HIM)
México, State of Mexico, CP 06720
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
México, State of Mexico, CP 14000
Hospital General y de Alta Especialidad Dr. Manuel Gea González
México, State of Mexico, CP 14080
Instituto Nacional de Enfermedades Respiratorias (INER)
México, State of Mexico, CP 14080
San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí
San Luis Potosí City, CP 78240
About this study
Official title: An Observational Study to Characterize Children and Adults With Influenza Like Illness (ILI) in Mexico
A study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with H1N1.
Read the detailed description
In March 2009, a new influenza A virus, novel H1N1 (commonly referred to as "swine flu"), began causing an increase in reports of influenza-like illness in North America. Although the virus subsequently spread rapidly around the world, the earliest reported outbreak of cases occurred in Mexico City, which is seen as the epicenter of the influenza pandemic, the world's first in 40 years.
Many questions remain about this emerging pandemic and the virus causing it, the answers to which could better inform patient management and policy decisions both in Mexico and internationally. Sparse reliable clinical research data have been collected on the natural history of the disease, on the risk factors associated with severe disease, or on the severity of this pandemic influenza as compared to seasonal influenzas. This study is an initial step to better characterize individuals in Mexico who develop influenza-like illness (including illness caused by novel H1N1), to describe the clinical management of those individuals, and to assess their short-term outcome. The planned data collection will provide timely information to inform policy and guidelines for the local populations and governments involved and may also be used to design future ancillary studies of this influenza virus and/or studies of other emerging infectious diseases.
The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and to describe clinical course over a period of at least 28 days after enrollment.
- Conditions
- Influenza-like Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized | Subjects who are hospitalized due to influenza-like illness | |
| Non-hospitalized | Subjects who are not hospitalized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses
Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment
Measured: 5 years
Secondary outcomes (5)
Death
For all participants, to estimate the percentage who die
Measured: 5 years
Hospitalization
For all participants, to estimate the percentages who require hospitalization due to severe influenza
Measured: 5 years
Risk factors
For all participants, to determine risk factors for severe disease
Measured: 5 years
Repository of oropharyngeal and nasal samples
Establish a repository of oropharyngeal and nasal samples to determine a precise diagnosis, to molecularly characterize the virus
Measured: 5 years
Repository of serum and PBMC
Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startApr 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza-like IllnessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexican Emerging Infectious Diseases Clinical Research Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Secretaria de Salud, Mexico, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Instituto Nacional de Enfermedades Respiratorias, National Institute of Pediatrics, Mexico, Hospital General Dr. Manuel Gea González, Hospital Infantil de Mexico Federico Gomez, Hospital Central "Dr. Ignacio Morones Prieto"
- Responsible party
- Sponsor
- Investigators
- Arturo Galindo Fraga, Dr., Principal investigator, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)Ana Alejandra Ortiz Hernández, Dr., Principal investigator, Instituto Nacional de Pediatría
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418287
- Sponsor's protocol ID
- ILI002
- Other IDs
- HHSN272200900003I
- Status last verified
- Sep 2014
- First submitted
- 15 Aug 2011
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Galindo-Fraga A, Guerra-de-Blas PDC, Ortega-Villa AM, Mateja A, Ruiz Quinones JA, Ramos Cervantes P, Ledesma Barrientos F, Ortiz-Hernandez AA, Llamosas-Gallardo B, Ramirez-Venegas A, Valdez Vazquez R, Noyola Chepitel D, Moreno-Espinosa S, Powers JH, Guerrero ML, Ruiz-Palacios GM, Beigel JH; Mexican Emerging Infectious Diseases Network. Different Clinical Presentations of Human Rhinovirus Species Infection in Children and Adults in Mexico. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac303. doi: 10.1093/ofid/ofac303. eCollection 2022 Jul.
PubMed 35891697Galindo-Fraga A, Ortiz-Hernandez AA, Ramirez-Venegas A, Vazquez RV, Moreno-Espinosa S, Llamosas-Gallardo B, Perez-Patrigeon S, Salinger M, Freimanis L, Huang CY, Gu W, Guerrero ML, Beigel J, Ruiz-Palacios GM; La Red ILI 002 Study Group. Clinical characteristics and outcomes of influenza and other influenza-like illnesses in Mexico City. Int J Infect Dis. 2013 Jul;17(7):e510-7. doi: 10.1016/j.ijid.2013.01.006. Epub 2013 Feb 14.
PubMed 23416208
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Characterize Children and Adults With Influenza Like Illness (ILI) in Mexico
- ClinicalTrials.gov ID
- NCT01418287
- Acronym / sponsor ID
- ILI002
- Conditions
- Influenza-like Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,819 participants (actual)
- Lead sponsor
- Mexican Emerging Infectious Diseases Clinical Research NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Secretaria de Salud, Mexico, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Instituto Nacional de Enfermedades Respiratorias, National Institute of Pediatrics, Mexico, Hospital General Dr. Manuel Gea González, Hospital Infantil de Mexico Federico Gomez, Hospital Central "Dr. Ignacio Morones Prieto"
- Study start
- Apr 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with H1N1.
Detailed description
In March 2009, a new influenza A virus, novel H1N1 (commonly referred to as "swine flu"), began causing an increase in reports of influenza-like illness in North America. Although the virus subsequently spread rapidly around the world, the earliest reported outbreak of cases occurred in Mexico City, which is seen as the epicenter of the influenza pandemic, the world's first in 40 years.
Many questions remain about this emerging pandemic and the virus causing it, the answers to which could better inform patient management and policy decisions both in Mexico and internationally. Sparse reliable clinical research data have been collected on the natural history of the disease, on the risk factors associated with severe disease, or on the severity of this pandemic influenza as compared to seasonal influenzas. This study is an initial step to better characterize individuals in Mexico who develop influenza-like illness (including illness caused by novel H1N1), to describe the clinical management of those individuals, and to assess their short-term outcome. The planned data collection will provide timely information to inform policy and guidelines for the local populations and governments involved and may also be used to design future ancillary studies of this influenza virus and/or studies of other emerging infectious diseases.
The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and to describe clinical course over a period of at least 28 days after enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized | – | –Subjects who are hospitalized due to influenza-like illness |
| Non-hospitalized | – | –Subjects who are not hospitalized |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with influenza-like illness presenting to clinical sites in Mexico
Key inclusion criteria (6 listed)
- Signed informed consent by participant, or for pediatric participants, signed informed consent by parent/legal guardian and, where appropriate, signed assent by participant
- At least one respiratory symptom (e.g., shortness of breath, postnasal drip, cough) and
- One of the following criteria:
- Fever (≥ 38 °C by any method: oral, axillary, etc.) on examination or participant-reported fever (≥ 38° C) or feverishness in the past 24 hours
- One or more non-respiratory symptoms (e.g., malaise, headache, myalgia,chest pain)
Key exclusion criteria (2 listed)
- The onset of illness is more than 48 hours after hospitalization.
- Participants previously included in this study within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses
Time frame: 5 years
Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment
5 secondary outcomes
Death
Time frame: 5 years
Hospitalization
Time frame: 5 years
Risk factors
Time frame: 5 years
Repository of oropharyngeal and nasal samples
Time frame: 5 years
Repository of serum and PBMC
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Derived from this study: PubMed 35891697Galindo-Fraga A, Guerra-de-Blas PDC, Ortega-Villa AM, Mateja A, Ruiz Quinones JA, Ramos Cervantes P, Ledesma Barrientos F, Ortiz-Hernandez AA, Llamosas-Gallardo B, Ramirez-Venegas A, Valdez Vazquez R, Noyola Chepitel D, Moreno-Espinosa S, Powers JH, Guerrero ML, Ruiz-Palacios GM, Beigel JH; Mexican Emerging Infectious Diseases Network. Different Clinical Presentations of Human Rhinovirus Species Infection in Children and Adults in Mexico. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac303. doi: 10.1093/ofid/ofac303. eCollection 2022 Jul.
- Derived from this study: PubMed 23416208Galindo-Fraga A, Ortiz-Hernandez AA, Ramirez-Venegas A, Vazquez RV, Moreno-Espinosa S, Llamosas-Gallardo B, Perez-Patrigeon S, Salinger M, Freimanis L, Huang CY, Gu W, Guerrero ML, Beigel J, Ruiz-Palacios GM; La Red ILI 002 Study Group. Clinical characteristics and outcomes of influenza and other influenza-like illnesses in Mexico City. Int J Infect Dis. 2013 Jul;17(7):e510-7. doi: 10.1016/j.ijid.2013.01.006. Epub 2013 Feb 14.
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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.
Arturo Galindo Fraga, Dr. principal investigator
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
Ana Alejandra Ortiz Hernández, Dr. principal investigator
Instituto Nacional de Pediatría
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza-like Illness, run by Mexican Emerging Infectious Diseases Clinical Research Network 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 6 inclusion and 2 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 11 Sep 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses (time frame: 5 years). 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 NCT01418287, which also lists 2 linked publications.
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 11 Sep 2014.