Status:
RECRUITING
European Trial Into Mpox Infection
Lead Sponsor:
Miquel Ekkelenkamp
Collaborating Sponsors:
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Erasmus Medical Center
Conditions:
Monkeypox
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease. The main questions it aims to answer ...
Eligibility Criteria
Inclusion
- Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
- The presence of active skin or mucosal lesion(s)
- Signed Informed Consent Form
Exclusion
- Age \<18 years.
- Body weight \<40 kg
- Pregnant and breastfeeding patients are not eligible for inclusion in this study.
- Lack of mental capacity to provide informed consent
- Trial participation is considered not in the best interest of patient
- Known hypersensitivity to the active substance or to any of the excipients of the study drug.
- Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)
- Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.
- The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated
- The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.
- The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06156566
Start Date
August 9 2024
End Date
August 1 2026
Last Update
March 28 2025
Active Locations (12)
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1
Institute of Tropical Medicine
Antwerp, Antwerp, Belgium, 2000
2
Cliniques Universitaires St. Luc
Brussels, Belgium, 1200
3
APHP St. Louis
Paris, France, 75010
4
Universitätsklinikum Bonn
Bonn, Germany, 53127