Assessment of the Increased Risk of Infection Following an Ultratrail

Infections Clinical Trial

— INFultra  

Official title:

Assessment of the Increased Risk of Infection Following an Ultratrail

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089174
• Other study ID #: 2023/CHU/23
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Simon BOSSIS
• Phone: 04 77 42 17 00
• Email: infection.postultratrail[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1300
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Immune Deficiency
• Immunologic Deficiency Syndromes
• Infections
• Running

Intervention

Other:
• Ultra-trail
Questionnaires sent to runners at various pre-race and post-race times (Day3, Day6, Day10, Day14 and Day21)

Locations

Country	Name	City	State
Réunion	CHU Réunion	Saint-Denis

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion	Hôpital Privé de la Loire- Saint Etienne, Université Jean Monnet-Saint-Etienne

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 21
Secondary	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.	Day 21
Secondary	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.	Day 21
Secondary	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).	Day 21
Secondary	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).	Day 21
Secondary	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).	Day 21