Assessment of the Increased Risk of Infection Following an Ultratrail (INFultra)
Primary Purpose
Running, Immune Deficiency, Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
Ultra-trail
Sponsored by
About this trial
This is an interventional diagnostic trial for Running focused on measuring Immune deficiency, Ultra-running, Infection
Eligibility Criteria
Inclusion Criteria: > 18 years Participating in a Grand Raid de la Réunion 2023 race (Mascareignes, Trail de Bourbon, Diagonale des Fous) Have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires Do not object to the research Exclusion Criteria: Do not understand French A protected adult (guardianship or curatorship) or under court protection
Sites / Locations
- CHU Réunion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exposed (Runners)
Non-exposed (companions)
Arm Description
Ultra-endurance runners taking part in an ultra-trail of 72 km, 109 km or 165 km
Runners' companions not running
Outcomes
Primary Outcome Measures
Increased risk of infection
Comparing the incidence of all infectious symptoms in runners taking part in one of the Grand Raid races (exposed subjects) with the incidence of infectious symptoms in those accompanying them on the race.
fever, congestion, stuffy nose, sneezing, shortness of breath, vomiting, diarrhea, headache, sore throat, general fatigue, burning and urinary symptoms, other infectious symptoms; associated with major infections (respiratory, skin, gastrointestinal, urinary, other)
Secondary Outcome Measures
Kinetic of infections' appearance
Kinetics of the onset of infectious symptoms within 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects) and their companions (unexposed subjects). Survival curves over the 3 weeks post-race will be produced.
An on-line questionnaire will be used to collect infectious data.
Risk factors: running distance
Identify if the distance of the race in which the runner participates is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
An on-line questionnaire will be used to collect data related to the race distance.
Risk factors: training volume
Identify if the runner's training volume is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Risk factors: sex of the runner
Identify if sex of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Risk factors: age category
Identify if the age of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Full Information
NCT ID
NCT06089174
First Posted
August 11, 2023
Last Updated
October 16, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
Collaborators
Université Jean Monnet-Saint-Etienne, Hôpital Privé de la Loire- Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT06089174
Brief Title
Assessment of the Increased Risk of Infection Following an Ultratrail
Acronym
INFultra
Official Title
Assessment of the Increased Risk of Infection Following an Ultratrail
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
Collaborators
Université Jean Monnet-Saint-Etienne, Hôpital Privé de la Loire- Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence.
The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Running, Immune Deficiency, Infections
Keywords
Immune deficiency, Ultra-running, Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a descriptive cohort study comparing the occurrence of infection between exposed (runners of an ultra-trail) and unexposed subjects (their companions).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exposed (Runners)
Arm Type
Experimental
Arm Description
Ultra-endurance runners taking part in an ultra-trail of 72 km, 109 km or 165 km
Arm Title
Non-exposed (companions)
Arm Type
No Intervention
Arm Description
Runners' companions not running
Intervention Type
Other
Intervention Name(s)
Ultra-trail
Intervention Description
Questionnaires sent to runners at various pre-race and post-race times (Day3, Day6, Day10, Day14 and Day21)
Primary Outcome Measure Information:
Title
Increased risk of infection
Description
Comparing the incidence of all infectious symptoms in runners taking part in one of the Grand Raid races (exposed subjects) with the incidence of infectious symptoms in those accompanying them on the race.
fever, congestion, stuffy nose, sneezing, shortness of breath, vomiting, diarrhea, headache, sore throat, general fatigue, burning and urinary symptoms, other infectious symptoms; associated with major infections (respiratory, skin, gastrointestinal, urinary, other)
Time Frame
Day 21
Secondary Outcome Measure Information:
Title
Kinetic of infections' appearance
Description
Kinetics of the onset of infectious symptoms within 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects) and their companions (unexposed subjects). Survival curves over the 3 weeks post-race will be produced.
An on-line questionnaire will be used to collect infectious data.
Time Frame
Day 21
Title
Risk factors: running distance
Description
Identify if the distance of the race in which the runner participates is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
An on-line questionnaire will be used to collect data related to the race distance.
Time Frame
Day 21
Title
Risk factors: training volume
Description
Identify if the runner's training volume is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Time Frame
Day 21
Title
Risk factors: sex of the runner
Description
Identify if sex of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Time Frame
Day 21
Title
Risk factors: age category
Description
Identify if the age of the runner is a risk factor associated with the risk of infection in the 21 days following one of the Grand Raid de La Réunion races in runners (exposed subjects).
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
> 18 years
Participating in a Grand Raid de la Réunion 2023 race (Mascareignes, Trail de Bourbon, Diagonale des Fous)
Have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires
Do not object to the research
Exclusion Criteria:
Do not understand French
A protected adult (guardianship or curatorship) or under court protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon BOSSIS
Phone
04 77 42 17 00
Email
infection.postultratrail@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Laetitia BERLY, PhD
Phone
0262906286
Email
laetitia.berly@chu-reunion.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas BOUSCAREN, MD
Organizational Affiliation
CHU de la Réunion
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
Réunion
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of the Increased Risk of Infection Following an Ultratrail
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