Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV

Monkeypox Clinical Trial

— MASH 1  

Official title:

Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965427
• Other study ID #: 606
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: NEAT ID Foundation
• Contact: Debbie Roberts, PhD
• Phone: 07956761151
• Email: debbie.roberts[@]rokcservices.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This data collection study aims to describe and compare the outcomes of Mpox on people living with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP). The study also aims to identify risk factors for specific Mpox outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of MPX was more than 90 days prior to data collection

• Confirmed MPX infection by documented PCR testing of lesions between 1st May 2022 to 1st December 2023

• At least 18 years of age

• Cases (PLWHIV + MPX) i) Documented HIV-1 infection

• Cases (PrEP users + MPX) i) Attended a clinic to receive PrEP

Exclusion Criteria:

• MPX diagnosed based on clinical criteria only

• MPX diagnosis was within the last 90 days

Related Conditions & MeSH terms

• Coinfection
• HIV Coinfection
• HIV Infections
• Monkeypox

Intervention

Other:
• No intervention
Study is retrospective data collection only

Locations

Country	Name	City	State
France	Hôpital Bichat Claude Bernard	Paris
France	Hôpital Pitié-Salpêtrière	Paris
Poland	Euroguidelines	Warsaw
Spain	Hospital Universitari Vall d'Hebron	Barcelona
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
NEAT ID Foundation	European Commission, PENTA Foundation, VERDI Consortium

Countries where clinical trial is conducted

France,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Mpox lesions	Severity of lesions will be assessed by the peak number of lesions and peak number of sites.; Skin lesion at peak severity score: Not presenting with skin lesions (0 skin lesions); Mild (<25 lesions); Moderate (25-99 skin lesions); Severe (100-250 skin lesions); Very severe (>250 skin lesions); Site of lesion will also be collected as part of the severity assessment: Genital lesions (defined as involvement of either vulva or vaginal mucosa or penis, pubic area); Ano-rectal/perianal lesions; Oral mucosa (lips/gums/oral/pharynx) lesions; Face; Trunk (chest/torso/abdomen/back); Limbs (arms/forearms/legs/hands/feet) on the body.	From date of disease onset (first symptom) until date of peak number of lesions and sites recorded (up to 3 months)
Primary	Clinical complications associated with Mpox	Complications which will be collected are as follows: Severe rectal and/or perianal pain (i.e. due to perianal/anal abscess, proctitis); Tonsillitis and/or dysphagia; Secondary bacterial infection on affected skin; Urological complications (genital oedema, urinary retention); Ocular involvement (conjunctivitis, corneal involvement, periorbital cellulitis); Central nervous system involvement (encephalitis, meningitis, focal neurology signs); Pneumonia/pulmonary abscess or necrotizing involvement; Myocarditis; Diarrhoea; The definition of a mental health condition will be that reported by the patient and recognized in the ICD-10 classification.	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)
Primary	Percentage of hospitalisations	percentage of hospitalisations for clinical reasons only (i.e. not for precautionary measures or quarantine).	1st May 2022 to 1st December 2023
Primary	Death		From date of disease onset (first symptom) until date of death related to Mpox (up to 3 months)
Primary	Differences in the clinical manifestation of MPX in PLWHIV and PrEP users	Clinical manifestations will include: Severity and time to resolution of lesions, severity of disease, clinical complications, drug treatments, length of hospitalisations, and number of deaths.; severe disease is defined as: Adults with severe clinical illness (e.g. National Early Warning Score [NEWS] 2 score of =5), which may include significant lower respiratory symptoms, confusion/encephalitis, and other complications (e.g. secondary bacterial infection, sepsis); Widely disseminated lesions and very many in number (=100); Suspected infection of the cornea; Severe, refractory pain from lesions requiring hospitalisation to achieve symptomatic control; Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow); Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged =16 years.	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)
Primary	Differences in the clinical manifestation of MPX in PLWHIV by CD4 and VL.	Clinical manifestations will include: Severity and time to resolution of lesions, severity of disease, clinical complications, drug treatments, length of hospitalisations, and number of deaths.; severe disease is defined as: Adults with severe clinical illness (e.g. National Early Warning Score [NEWS] 2 score of =5), which may include significant lower respiratory symptoms, confusion/encephalitis, and other complications (e.g. secondary bacterial infection, sepsis); Widely disseminated lesions and very many in number (=100); Suspected infection of the cornea; Severe, refractory pain from lesions requiring hospitalisation to achieve symptomatic control; Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow); Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged =16 years.	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)
Secondary	Number of MPX patients attending as a percentage of total number of patients the sites have seen over a set period of time (from first Mpox patient to last Mpox patient)		1st May 2022 to 1st December 2023
Secondary	Length of stay in hospital for inpatients treated for Mpox		From date of hospital admission for Mpox until date of hospital discharge (up to 3 months)
Secondary	Time to lesion resolution (if known)		From date of disease onset (first symptom) until date of lesion resolution (up to 3 months)
Secondary	Differences in the clinical manifestation of MPX in PLWHIV and PrEP users by co-morbidities.	Clinical manifestations will include: Severity and time to resolution of lesions, severity of disease, clinical complications, drug treatments, length of hospitalisations, and number of deaths.; severe disease is defined as: Adults with severe clinical illness (e.g. National Early Warning Score [NEWS] 2 score of =5), which may include significant lower respiratory symptoms, confusion/encephalitis, and other complications (e.g. secondary bacterial infection, sepsis); Widely disseminated lesions and very many in number (=100); Suspected infection of the cornea; Severe, refractory pain from lesions requiring hospitalisation to achieve symptomatic control; Lesions associated with complications due to pain or swelling (e.g., constipation, urinary retention, inability to swallow); Confirmed infection, regardless of severity, in immunocompromised people, pregnant women, or children aged =16 years.	From date of disease onset (first symptom) until date of clinical resolution e.g. lesion resolution, hospital discharge or death(up to 3 months)