Clinical trial NCT05476744: Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
Official title: Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monkeypox
Keywords: Monkeypox
Viral clearance
Viral dynamics
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Sponsor class: OTHER
Collaborators: name: IrsiCaixa
name: CEEISCAT
First posted: 2022-07-27
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients with monkeypox infection.

Brief summary: The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

Detailed description: Starting in early May 2022 a large number of cases of Monkeypox have been reported in non-endemic countries. Although initial cases appeared to be linked to travel, the majority of subsequent cases appear to have no travel associated risk factors and these cases have predominantly occurred amongst Men who have Sex with Men (MSM) suggesting autochthonous transmission associated with sexual networks.

Monkeypox is known to be transmitted by close contact with skin lesions of infected individuals and/or via droplets. It is known that the virus can be detected from skin lesions, in blood, in throat swabs and on occasion urine samples. There is limited information as to whether the virus can be detected or persist in other sites including semen. Serial virological monitoring has been conducted in a small number of individuals and demonstrates that prolonged shedding for at least 2-3 weeks appears to be relatively common. To help control the current outbreak health authorities have used a number of strategies including identifying and isolating cases of monkeypox combined with contact tracing and limited use of ring-vaccination strategies. Because the number of cases seen outside of endemic areas has previously been limited, there is inadequate data to guide decision-making about the duration of isolation, but this is critical to the management of the current outbreak.

The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.

Eligibility criteria: * Inclusion Criteria

  1. Adult male or female individuals of ≥18 years old.
  2. Examined by a specialist in sexually transmitted infections (STIs) and found to have lesions suggestive of monkeypox.
  3. Symptomatic with symptoms onset date ≤10 days prior to screening/baseline visit.
  4. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
  5. Has understood the information provided and capable of giving informed consent.
* Exclusion criteria:

  1. Severe disease - defined as requires admission to hospital
  2. Inability to consent and/or comply with trial protocol
  3. An alternative confirmed diagnosis that can fully explain the illness

Primary outcomes:
measure: Viral clearance in skin lesions
timeFrame: From day 1 to day 57
measure: Viral clearance in blood
timeFrame: From day 1 to day 57
measure: Viral clearance in oropharyngeal swabs
timeFrame: From day 1 to day 57
measure: Viral clearance in rectum swabs
timeFrame: From day 1 to day 57
measure: Viral clearance in semen discharge
timeFrame: From day 1 to day 57
measure: Viral clearance in vaginal discharge
timeFrame: From day 1 to day 57
Secondary outcomes:
measure: Humoral responses against monkeypox
timeFrame: At baseline and 1, 3, and 6 months later
measure: Cellular responses against monkeypox
timeFrame: At baseline and 1, 3, and 6 months later
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Atenció Primària Metropolitana Nord
state: Barcelona
city: Barcelona
country: Spain
facility: Drassanes Vall d'Hebron Centre for International Health and Infectious diseases
city: Barcelona
country: Spain
facility: BCN Checkpoint
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References: