Mycetoma
Conditions
Interventions
Fosravuconazole and therapeutic surgery
Sponsors
Drug for Neglected Diseases Intiative
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be = 15 years of age, at the time of signing the informed consent. Written informed consent from the participant. If the participant is less than 18 years old, there must be a signed consent from a parent or legal guardian AND a written assent signed by the participant. 2. Male or female clinical trial participants 3. Clinical trial participants with eumycetoma confirmed by PCR 4. Eumycetoma lesion requiring surgery 5. Able to comply with protocol procedures and available for follow-up. 6. Eumycetoma lesion = 2 cm and < 16 cm in diameter A lesion will be defined as either one single lesion in one anatomical area or multiple lesions in one anatomical area provided that the total affected area remains within the given limits 7. Female specific inclusion criteria Negative pregnancy test 8. If female of childbearing potential, using or willing to start highly effective contraception for the period of the trial to 3 months after completing study treatment (total of 15 months minimum).
Exclusion criteria
Exclusion criteria: Inclusion criteria 1. Participant must be = 15 years of age, at the time of signing the informed consent. Written informed consent from the participant. If the participant is less than 18 years old, there must be a signed consent from a parent or legal guardian AND a written assent signed by the participant. 2. Male or female clinical trial participants 3. Clinical trial participants with eumycetoma confirmed by PCR 4. Eumycetoma lesion requiring surgery 5. Able to comply with protocol procedures and available for follow-up. 6. Eumycetoma lesion = 2 cm and 450 ms in males, >470 ms in females)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of clinical trial participants with complete cure at 12 months (number of clinical trial participants with complete cure out of total number of participants who received fosravuconazole 200 mg). | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of clinical trial participants with a TEAE, receiving at least one dose of study treatment ;Median and coefficient of variability (CV%) of Cmin and AUC0-24 on each pharmacokinetic assessment time point, before and after surgery, and mean and variability of population pharmacokinetic parameters | — |
Countries
Kenya, Senegal
Contacts
Public ContactLinet Otieno
Head of Communications
Outcome results
None listed