MoViE: Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Viral clearance in skin lesions [From day 1 to day 57]
Time to undetectable monkeypox viral load in skin lesions
- Viral clearance in blood [From day 1 to day 57]
Time to undetectable monkeypox viral load in blood
- Viral clearance in oropharyngeal swabs [From day 1 to day 57]
Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs
- Viral clearance in rectum swabs [From day 1 to day 57]
Time to undetectable monkeypox viral load (Ct) in rectum swabs in patients with monkeypox
- Viral clearance in semen discharge [From day 1 to day 57]
Time to undetectable monkeypox viral load in semen in patients with monkeypox
- Viral clearance in vaginal discharge [From day 1 to day 57]
Time to undetectable monkeypox viral load in vaginal discharge in patients with monkeypox
Secondary Outcome Measures
- Correlation between clinical features and time to viral clearance [From day 1 to day 57]
Correlation between clinical symptoms and time to undetectable monkeypox viral load (Ct). Clinical symptoms will include: General symptoms indicative of viremia, localized cutaneous lesions, generalized cutaneous lesions, adenopathies, and proctitis.
- Correlation between clinical features and demographic factors [From day 1 to day 57]
Correlation between clinical symptoms and demographic factors. Clinical symptoms will include: General symptoms indicative of viremia, localized cutaneous lesions, generalized cutaneous lesions, adenopathies, and proctitis.
- Correlation between clinical features and epidemiological factors [Baseline]
Correlation between clinical symptoms and epidemiological factors. Clinical symptoms will include: General symptoms indicative of viremia, localized cutaneous lesions, generalized cutaneous lesions, adenopathies, and proctitis.
- Factors associated to monkeypox acquisition and access to health care [Baseline]
Describe factors associated to monkeypox acquisition and access to health care
- Humoral and cellular responses against monkeypox [At baseline and 1, 3, and 6 months later]
Description of humoral and cellular responses against monkeypox at baseline, 1, 3, and 6 months later in a subset of participants
Eligibility Criteria
Criteria
- Inclusion Criteria
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Adult male or female individuals of ≥18 years old.
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Examined by a specialist in sexually transmitted infections (STIs) and found to have lesions suggestive of monkeypox.
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Symptomatic with symptoms onset date ≤10 days prior to screening/baseline visit.
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Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial.
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Has understood the information provided and capable of giving informed consent.
- Exclusion criteria:
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Severe disease - defined as requires admission to hospital
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Inability to consent and/or comply with trial protocol
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An alternative confirmed diagnosis that can fully explain the illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | Spain | 08916 |
| 2 | Atenció Primària Metropolitana Nord | Sabadell | Barcelona | Spain | 08204 |
| 3 | BCN Checkpoint | Barcelona | Spain | 08015 | |
| 4 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 |
Sponsors and Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- IrsiCaixa
- CEEISCAT
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MoViE Study