Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims. (EMIRATH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02868541
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 16, 2016
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management.

This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.


Condition or disease Intervention/treatment
Acute Respiratory Infection Other: Naso pharyngeal swab

Layout table for study information
Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020

Group/Cohort Intervention/treatment
Haaj pilgrim
Patient that are showing at the traveler hospital health center requiring the mandatory Meningococcal vaccine ACYW135
Other: Naso pharyngeal swab



Primary Outcome Measures :
  1. The number of new viruses and/or bacteria identified and characterized by respiratory and pharyngeal carriage among pilgrims between the departure and the return of Hajj [ Time Frame: up to 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Travelers pilgrims over 18 years leaving for the Hajj pilgrimage and consulting at the international vaccination service of the Public Assistance of Marseille Hositals for the mandatory meningococcal ACYW135 vaccination.
Criteria

Inclusion Criteria:

  • All travelers presenting during the study period in the service of international vaccination for mandatory meningococcal ACYW135 vaccination ,
  • Affiliated to a social security insurance regime
  • Male or Female
  • Aged over 18 years
  • Having signed informed consent form
  • able to understand and answer the study questions

Exclusion Criteria

  • Patients aged under 18
  • Patient whose protocol compliance seems unlikely to investigator
  • Participant in another clinical trial or in exclusion period of a previous clinical trial,
  • Unable to understand the nature and objectives of the study,
  • Refusing to sign the informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868541


Contacts
Layout table for location contacts
Contact: Philippe GAUTRET, Dr 04 91 36 87 52 philippe.gautret@ap-hm.fr
Contact: Alexandra GIULIANI 04 91 38 28 70 alexandra.giuliani@ap-hm.fr

Locations
Layout table for location information
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: philippe BROUQUI         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02868541    
Other Study ID Numbers: 2013-29
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique Hopitaux De Marseille:
microorganisms
pilgrim
hajj
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Respiratory Tract Infections
Respiratory Tract Diseases