- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06089174
Assessment of the Increased Risk of Infection Following an Ultratrail (INFultra)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint-Denis, Reunion, 97400
- Chu Reunion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exposed (Runners)
Ultra-endurance runners taking part in an ultra-trail of 72 km, 109 km or 165 km
|
Questionnaires sent to runners at various pre-race and post-race times (Day3, Day6, Day10, Day14 and Day21)
|
|
No Intervention: Non-exposed (companions)
Runners' companions not running
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increased risk of infection
Time Frame: Day 21
|
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) |
Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinetic of infections' appearance
Time Frame: Day 21
|
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. |
Day 21
|
|
Risk factors: running distance
Time Frame: Day 21
|
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. |
Day 21
|
|
Risk factors: training volume
Time Frame: Day 21
|
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).
|
Day 21
|
|
Risk factors: sex of the runner
Time Frame: Day 21
|
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).
|
Day 21
|
|
Risk factors: age category
Time Frame: Day 21
|
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).
|
Day 21
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicolas BOUSCAREN, MD, CHU de la réunion
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/CHU/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infections
-
University Hospital, Strasbourg, FranceRecruiting
-
Han TongyanCompletedLower Respiratory Tract Infections | RSV InfectionsChina
-
Ab&B Bio-tech Co., Ltd.JSYither Biotech Co., LtdRecruitingRespiratory Syncytial Virus InfectionsChina
-
GlaxoSmithKlineRecruiting
-
ShionogiRecruitingRespiratory Syncytial Virus InfectionsUnited States, Bulgaria, South Africa, Poland, Japan
-
Kevin WinthropAN2 Therapeutics, IncRecruitingMycobacterium Abscessus InfectionUnited States
-
EyeGene Inc.BMI KoreaRecruitingMeningococcal InfectionsSouth Korea
-
Dilla UniversityNot yet recruiting
-
Emergent BioSolutionsDepartment of Health and Human Services; Centers for Disease Control and PreventionNot yet recruitingInfections, Bacterial
-
PfizerNot yet recruitingRespiratory Syncytial Virus Infections
Clinical Trials on Ultra-trail
-
Centre Hospitalier Universitaire de Saint EtienneTerminated
-
CPTS Paris 8ICUREsearchEnrolling by invitationOccupational StressFrance
-
University of British ColumbiaMcMaster UniversityRecruitingTelerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT) (TRAIL-RCT)Infarction | Cardiovascular Diseases | Stroke | Brain Diseases | Central Nervous System Diseases | Brain Ischemia | Cerebral Infarction | Brain Infarction | Stroke, Ischemic | Stroke Hemorrhagic | Cerebral Vascular Accident | Cerebral Vascular Disorder | Cerebral InjuryCanada
-
Portland State UniversityCompletedPregnancy in Adolescence
-
University of ManitobaUnity Health Toronto; University of Toronto; Ontario Agency for Health Protection...UnknownCardiovascular Diseases | Diabetes Mellitus | Cardiovascular Risk FactorCanada
-
Huazhong University of Science and TechnologyCompletedSurgical Procedure, Unspecified | Obstructive JaundiceChina
-
Sichuan Clover Biopharmaceuticals, Inc.Completed
-
Clover Biopharmaceuticals AUS Pty LtdCompletedPeritoneal MalignanciesAustralia
-
Sichuan Clover Biopharmaceuticals, Inc.TerminatedPeritoneal CarcinomatosisChina
-
Clover Biopharmaceuticals AUS Pty LtdCompletedMalignant Pleural EffusionsAustralia