Influenza Nos or Influenza-like IllnessNCT02378090
A Study to Determine the Causes and Identify Increases in Influenza-Like Illness (ILI) in Mexico
An observational study of Influenza Nos or Influenza-like Illness and Acute Respiratory Infections, run by Mexican Emerging Infectious Diseases Clinical Research Network at 6 sites in Mexico.
Trial summary
The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and Severe Acute Respiratory Infection (SARI), describe seasonal pattern of the pathological agents associated with ILI and SARI and to identify changes in severity of disease caused… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Influenza Nos or Influenza-like Illness, Acute Respiratory Infections
- How many people
- 888 participants
- Where
- 6 sitesMexico
- Study dates
- Jan 2015to Nov 2016
- 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: Subjects will be selected from hospitalized (within the last 24 hours) patients and outpatients that seek medical care due to ILI at the sites of La Red Network and meet inclusion criteria. Those who accept participation will be invited to participate, the study will be explained and informed consent will be obtained. The study population will include children and pregnant women.
Who may be able to join
- Signed informed consent by participant. In pediatric subjects, signed informed consent by the parent(s) or legal guardian(s) and, as required by the Institutional Ethics Committee (IEC), signed assent by participant.
- An acute respiratory infection with:
- Measured fever of ≥ 38°C or history of fever;
- Cough; and
- Onset within the last 10 days.
Who cannot join
- Onset of ILI illness while hospitalized for any other cause to avoid enrollment of potential nosocomial infections (nosocomial).
- Subjects previously included in this study within the last 30 days of enrollment.
- Having been cared for in the hospital for a period >24 hours.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Mexico6 sites
Hospital General y de Alta Especialidad Manuel Gea Gonzalez
Mexico City, D. F.
Hospital Infantil de Mexico Federico Gomez
Mexico City, D. F.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, D. F.
Instituto Nacional de Enfermedades Respiratorias
Mexico City, D. F.
Instituto Nacional de Pediatria
Mexico City, D. F.
Hospital Central Dr. Ignacio Morones Prieto/ Universidad Autonoma de San Luis Potosi
San Luis, Potosi
About this study
Official title: An Observational Study to Determine the Causes and Identify Increases in Influenza-Like Illness (ILI) in Mexico: The Mexican Emerging Infectious Disease Clinical Research Network (La Red)
The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and Severe Acute Respiratory Infection (SARI), describe seasonal pattern of the pathological agents associated with ILI and SARI and to identify changes in severity of disease caused by a specific agent.
Read the detailed description
The La Red Network clinical sites will enroll individuals presenting with ILI symptoms. A systematic sample will be chosen across all sites, with the goal of choosing 3 subjects who are outpatients and 3 subjects who are hospitalized every week at each site. It is recognized that, during seasons of low ILI activity, this enrollment goal may not be achieved. To be eligible for selection, subjects must be willing to sign informed consent, or provide informed consent/assent in the case of minors.
Subjects will be followed for a period of 28 days after enrollment to assess vital status. It is estimated that this study will enroll a maximum of 1872 subjects per year for an approximate 7488 subjects in the four years that the study proposes to enroll, depending upon the extent of ILI occurring during the period of this study.
Nasopharyngeal swabs, sputum samples, and blood samples will be obtained at enrollment. The nasopharyngeal swabs and, in adults > 18 years of age, portion of the blood for serum and peripheral blood mononuclear cells (PBMC) will be obtained for storage and shipped to the central repository located at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán for respiratory pathogen testing including real-time Polymerase Chain Reaction (PCR) and multiplex techniques.
All enrolled subjects will be assessed at enrollment, at 7 days (+3 days) and at 28 days (+/- 5 days) after enrollment to assess disease resolution and vital status.
The purpose of the study is to provide information regarding the pathogens causing ILI among patients seeking care at the La Red Network sites. The systematic collection of data over time will allow for the determination of seasonal patterns of different etiologic agents and the ability for early identification of the emergence of particular viruses, as well as the ability to identify changes in severity of disease signaled by an increase of severity, hospitalization and/or death attributable to a specific pathogen.
One important aspect of influenza infection is to the need to identify genetic factors associated with severity among patients who present with influenza and develop severe disease. Subjects will be given the option to opt out of the genetic testing by noting it on the informed consent form. This testing will be limited to studies related to respiratory viruses and influenza, and any study designed to use genetic testing. These studies will be submitted for review by the institutional review boards (IRBs) of the sites participating in the La Red Network.
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiologic agents causing ILI and SARI among patients seeking medical care at participating sites in Mexico.
Difference in the proportion of a determined isolated etiologic agent (or hospitalization) in the current 2 weeks (increases) in relation to the prior 8 weeks
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Nos or 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 888 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), Coordinación de Investigación en Salud, Mexico
- Responsible party
- Sponsor
- Investigators
- Arturo Galindo-Fraga, MD, Study chair, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranDaniel Noyola, MD, Study chair, Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378090
- Sponsor's protocol ID
- ILI-2014
- Status last verified
- Nov 2016
- First submitted
- 16 Feb 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine the Causes and Identify Increases in Influenza-Like Illness (ILI) in Mexico: The Mexican Emerging Infectious Disease Clinical Research Network (La Red)
- ClinicalTrials.gov ID
- NCT02378090
- Acronym / sponsor ID
- ILI-2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- Mexican Emerging Infectious Diseases Clinical Research NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Coordinación de Investigación en Salud, Mexico
- Study start
- Jan 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Mar 2015 (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.
The purpose of this observational study is to characterize individuals in Mexico who seek medical care for influenza-like illness (ILI) and Severe Acute Respiratory Infection (SARI), describe seasonal pattern of the pathological agents associated with ILI and SARI and to identify changes in severity of disease caused by a specific agent.
Detailed description
The La Red Network clinical sites will enroll individuals presenting with ILI symptoms. A systematic sample will be chosen across all sites, with the goal of choosing 3 subjects who are outpatients and 3 subjects who are hospitalized every week at each site. It is recognized that, during seasons of low ILI activity, this enrollment goal may not be achieved. To be eligible for selection, subjects must be willing to sign informed consent, or provide informed consent/assent in the case of minors.
Subjects will be followed for a period of 28 days after enrollment to assess vital status. It is estimated that this study will enroll a maximum of 1872 subjects per year for an approximate 7488 subjects in the four years that the study proposes to enroll, depending upon the extent of ILI occurring during the period of this study.
Nasopharyngeal swabs, sputum samples, and blood samples will be obtained at enrollment. The nasopharyngeal swabs and, in adults > 18 years of age, portion of the blood for serum and peripheral blood mononuclear cells (PBMC) will be obtained for storage and shipped to the central repository located at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán for respiratory pathogen testing including real-time Polymerase Chain Reaction (PCR) and multiplex techniques.
All enrolled subjects will be assessed at enrollment, at 7 days (+3 days) and at 28 days (+/- 5 days) after enrollment to assess disease resolution and vital status.
The purpose of the study is to provide information regarding the pathogens causing ILI among patients seeking care at the La Red Network sites. The systematic collection of data over time will allow for the determination of seasonal patterns of different etiologic agents and the ability for early identification of the emergence of particular viruses, as well as the ability to identify changes in severity of disease signaled by an increase of severity, hospitalization and/or death attributable to a specific pathogen.
One important aspect of influenza infection is to the need to identify genetic factors associated with severity among patients who present with influenza and develop severe disease. Subjects will be given the option to opt out of the genetic testing by noting it on the informed consent form. This testing will be limited to studies related to respiratory viruses and influenza, and any study designed to use genetic testing. These studies will be submitted for review by the institutional review boards (IRBs) of the sites participating in the La Red Network.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be selected from hospitalized (within the last 24 hours) patients and outpatients that seek medical care due to ILI at the sites of La Red Network and meet inclusion criteria. Those who accept participation will be invited to participate, the study will be explained and informed consent will be obtained. The study population will include children and pregnant women.
Key inclusion criteria (5 listed)
- Signed informed consent by participant. In pediatric subjects, signed informed consent by the parent(s) or legal guardian(s) and, as required by the Institutional Ethics Committee (IEC), signed assent by participant.
- An acute respiratory infection with:
Key exclusion criteria (3 listed)
- Onset of ILI illness while hospitalized for any other cause to avoid enrollment of potential nosocomial infections (nosocomial).
- Subjects previously included in this study within the last 30 days of enrollment.
- Having been cared for in the hospital for a period >24 hours.
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
Etiologic agents causing ILI and SARI among patients seeking medical care at participating sites in Mexico.
Time frame: 4 years
Difference in the proportion of a determined isolated etiologic agent (or hospitalization) in the current 2 weeks (increases) in relation to the prior 8 weeks
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 10 Nov 2016.
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, MD study chair
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Daniel Noyola, MD study chair
Hospital Central "Dr. Ignacio Morones Prieto"
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 Nos or Influenza-like Illness and Acute Respiratory Infections, 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 5 inclusion and 3 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 10 Nov 2016. 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?
Etiologic agents causing ILI and SARI among patients seeking medical care at participating sites in Mexico. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2016.