Ocular Complications of Mpox in the Democratic Republic Congo

NCT ID: NCT06579885

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-28
• Study Completion Date: 2025-06-29

Brief Summary

This is an observational study in which patients diagnosed with mpox will be enrolled, will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox. The study will primarily assess the presence of ophthalmological signs and symptoms at enrollment.

Detailed Description

This is an observational study in which patients diagnosed with mpox will be enrolled in two clinics in remote settings in the DR Congo (Tunda and Kole general hospital) where mpox outbreaks are ongoing. After providing informed consent, participants will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox. This includes history taking, clinical examination, technical examinations such as a dilated fundoscopic exam, a fluorescein test and a Schirmer test, and a conjunctival swab for tear collection for monkeypox virus (MPXV) detection. Pictures of the anterior and posterior segment will also be taken to aid later verification and interpretation of the study findings. If they are hospitalised for mpox (for clinical reasons or as part of their participation in another ongoing clinical trial at the study sites), they will be followed up for 14 days and examined during an unscheduled visit in the case of new or worsening severe issues. Otherwise, patients are followed up at day 14 (for those hospitalised), day 28 and day 59. Study participants will receive the same supportive eye care as non-study participants. Study participants will be compensated for their time lost and for transportation to the clinic.

The study will primarily assess the presence of ophthalmological signs and symptoms at enrollment, but also aims to describe the complications of mpox that may arise after that point in time.

Conditions

Monkeypox; Mpox (Monkeypox)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patient of any age or gender with laboratory-confirmed infection with MPXV
• Laboratory confirmation of MPXV infection less than 48 hours before inclusion
• Patient or culturally acceptable representative is willing and able to give informed consent or assent for participation in the study

Exclusion Criteria

• Patients for whom, in the judgment of the recruiting physician, participation in the study would interfere with routine optimal clinical care.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurens Liesenborghs, Professor

Role: STUDY_DIRECTOR

Institute of Tropical Medicine

Locations

Kamituga General Hospital

Kamituga, South Kivu, Democratic Republic of the Congo

Site Status: RECRUITING

Countries

Democratic Republic of the Congo

Central Contacts

Placide Mbala Kingebeni, Professor

Role: CONTACT

mbalaplacide@gmail.com

+243822851584

Other Identifiers

MPOX-EYE

Identifier Type: -

Identifier Source: org_study_id