NCT02378090

Brief 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 by a specific agent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
888

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

February 16, 2015

Last Update Submit

November 9, 2016

Conditions

Influenza Nos or Influenza-like IllnessAcute Respiratory Infections

Outcome Measures

Primary Outcomes (1)

  • 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

    4 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital General y de Alta Especialidad Manuel Gea Gonzalez

Mexico City, D. F., Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, D. F., Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, D. F., Mexico

Location

Instituto Nacional de Enfermedades Respiratorias

Mexico City, D. F., Mexico

Location

Instituto Nacional de Pediatria

Mexico City, D. F., Mexico

Location

Hospital Central Dr. Ignacio Morones Prieto/ Universidad Autonoma de San Luis Potosi

San Luis, Potosi, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will only be identified by the unique identifier assigned to each participant for the study. All repository samples will be stored for a maximum of 15 years after the last enrollment into the study; any remaining samples after this time will be destroyed, following Mexican and United States of America (USA) Federal regulations.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Arturo Galindo-Fraga, MD

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    STUDY CHAIR

  • Daniel Noyola, MD

    Hospital Central "Dr. Ignacio Morones Prieto"

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 4, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

ME(6)