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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

471

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-Denis, Reunion, 97400
        • Chu Reunion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicolas BOUSCAREN, MD, CHU de la réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Actual)

November 14, 2023

Study Completion (Actual)

November 14, 2023

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2023/CHU/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on Ultra-trail

Subscribe