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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05629299
Other study ID # RC31/22/0299
Secondary ID 2022-A01799-34
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2022
Est. completion date November 2024

Study information

Verified date November 2022
Source University Hospital, Toulouse
Contact Manon CARLES, MD
Phone 05 67 77 10 07
Email carles.man@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Given the current emerging epidemic of the MonkeyPox Virus (MPXV) and its route of transmission, the main objective of this pilot study is to characterize the presence of the MPXV in the semen of patients in the acute phase of infection and following this infection.


Description:

Since May 2022, a total of 16 000 new cases of Monkey Pox Virus infection has been reported in 76 non-endemic countries. The WHO has declared this epidemic as a public health emergency. Principal routes of transmission are direct skin or mucosa contact or aerosol transmission. The current epidemic mainly affects men having sexual relations with others men and men reporting having recent sexual relations with new or multiple partners. We may wonder if there is a risk of transmission during an intercourse. Moreover, Monkey pox virus infection in human testicle has not been studied yet. Among viruses that infect human semen, some viruses can persist for several months or even years in the semen of cured men. In this context, we propose a research project about the pathophysiology of MPXV in the male genital tract by a clinical approach. Men with a diagnosis of MPXV infection confirmed by a positive PCR and who agreed to be included as volunteer will go to CECOS at Paule de Viguier Hospital, Purpan. Each patient will take a semen and urine sample, have a blood sample and a saliva sample, and a skin sample in case of a lesion; the earliest after the confirmation of the diagnosis of the infection (before the 7th day, the days will be noted) then on Day 15, Day 30, Day 60, Day 90 and Day 180.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - in the acute phase of MPXV infection and whose PCR reveals the viral genome in a skin sample or in any other sample. - able to travel to the laboratory for the samples - who gave his free and informed consent and having signed the consent - Patient affiliated to a social security scheme or equivalent Exclusion Criteria: - Patient who has previously consulted for male infertility or who has previously performed an abnormal semen test (WHO standard) - Patient with ejaculation disorder or unable to collect semen or with abnormal semen volume (<1.5 mL). - Patient who presents serious clinical signs that do not allow him to travel to the investigation center. - Patient under a protection regime (including guardianship, curatorship or safeguard of justice)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Samples
Men will give semen, saliva, skin, urine and blood specimens

Locations

Country Name City State
France CHU Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary MPXV genomic DNA presence of MPXV DNA in the semen and others body fluids of infected patients in the acute phase and during the follow-up. Day 0
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