NCT01418287

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,819

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

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

April 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

4.1 years

First QC Date

August 15, 2011

Last Update Submit

September 10, 2014

Conditions

Influenza-like Illness

Outcome Measures

Primary Outcomes (1)

  • 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

    5 years

Secondary Outcomes (5)

  • Death

    5 years

  • Hospitalization

    5 years

  • Risk factors

    5 years

  • Repository of oropharyngeal and nasal samples

    5 years

  • Repository of serum and PBMC

    5 years

Study Arms (2)

Hospitalized

Subjects who are hospitalized due to influenza-like illness

Non-hospitalized

Subjects who are not hospitalized

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with influenza-like illness presenting to clinical sites in Mexico

You may qualify if:

  • 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

You may not qualify if:

  • The onset of illness is more than 48 hours after hospitalization.
  • Participants previously included in this study within the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Instituto Nacional de Pediatría (INP)

México, State of Mexico, CP 04530, Mexico

Location

Hospital Infantil de México Federico Gómez (HIM)

México, State of Mexico, CP 06720, Mexico

Location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

México, State of Mexico, CP 14000, Mexico

Location

Hospital General y de Alta Especialidad Dr. Manuel Gea González

México, State of Mexico, CP 14080, Mexico

Location

Instituto Nacional de Enfermedades Respiratorias (INER)

México, State of Mexico, CP 14080, Mexico

Location

San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí

San Luis Potosí City, CP 78240, Mexico

Location

Related Publications (2)

  • 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.

    PMID: 35891697DERIVED

  • Galindo-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.

    PMID: 23416208DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, PBMC and Nasopharingeal aspirates

Study Officials

  • Arturo Galindo Fraga, Dr.

    Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

    PRINCIPAL INVESTIGATOR

  • Ana Alejandra Ortiz Hernández, Dr.

    Instituto Nacional de Pediatría

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 17, 2011

Study Start

April 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

ME(6)