Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607548647895 Date of Registration: 29/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Drug for Mycetoma treatment phase 3 study
Official scientific title A multi-country, open-label, single-arm Phase IIIb clinical trial to evaluate the efficacy, safety, and pharmacokinetics of fosravuconazole 200 mg weekly dose for 12 months in combination with surgery in patients with eumycetoma
Brief summary describing the background and objectives of the trial Treatment depends on the causative agent: actinomycetoma responds well to combination antimicrobial therapy with cure rates above 90%, whereas eumycetoma remains challenging due to limited effective antifungal options. Itraconazole is the most common drug used for the treatment of eumycetoma, followed by terbinafine, while ketoconazole continues to be used in some LMICs despite safety concerns and its removal from the WHO Essential Medicines List. Newer azoles such as voriconazole and posaconazole are often unavailable, unaffordable, or show limited efficacy. Medical therapy is typically used alongside surgery to facilitate lesion removal and prevent relapses, as incomplete treatment is associated with frequent recurrence and may ultimately lead to amputation. Fosravuconazole (Fos) is an oral azole discovered by Eisai Co., Ltd, Japan. It has been approved for onychomycosis in Japan in 2018. Ravuconazole the active form of the prodrug fosravuconazole, is active against eumycetoma pathogens such as Madurella species M. mycetomatis, M. pseudomycetomatis, M. fahalii and other occasional agents such as S. boydii and F. senegalensis. A Phase II study conducted in Sudan compared the efficacy and safety of fosravuconazole (200 mg and 300 mg weekly) to itraconazole 400 mg daily, all given for 12 months with surgical removal of the mass at 6 months. Fosravuconazole showed no new safety concerns and, with lower pill burden and fewer drug interactions, remains a feasible alternative to itraconazole.To enable evaluation of fosravuconazole in more diverse populations, a Phase IIIb clinical trial is proposed to confirm its efficacy, safety, and pharmacokinetics in patients with eumycetoma caused by any etiologic organism across additional endemic regions, including Senegal, Kenya, and India
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) Phase 3b
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Mycetoma
Purpose of the trial Treatment: Drugs
Anticipated trial start date 31/01/2027
Actual trial start date
Anticipated date of last follow up 31/01/2029
Actual Last follow-up date
Anticipated target sample size (number of participants) 106
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Fosravuconazole and therapeutic surgery Fosravuconazole 200mg and surgery at 6 months 12 months Fosravuconazole 200 mg once on Days 1, 2, and 3 followed by weekly for a duration of 12 months with surgical excision of the mycetoma lesion performed at the 6 months’ time-point 106
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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). 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 1. Pregnancy or lactation at screening 2. Concomitant or severe diseases that may compromise the participant follow-up or evaluation (e.g psychiatric condition, uncontrolled HIV/AIDS, or diabetes mellitus, adrenocortical insufficiency) 3. Presence of loco-regional lymphatic extension, osteomyelitis, other bone involvement based on radiology or any pre- or co-existing condition that would preclude evaluation of the eumycetoma 4. The following concomitant medications are contraindicated: a. Drugs known to prolong QT interval or associated with torsades de pointes on CredibleMeds® (or equivalent) b. Strong CYP3A4 substrates with narrow therapeutic index (e.g., terfenadine, astemizole, cisapride, pimozide, ergot alkaloids, sirolimus, quinidine) c. Strong CYP3A4 inducers (e.g., rifampicin) d. Other systemic azole antifungals unless justified 5. ECG criteria; a. QTc prolongation (>450 ms in males, >470 ms in females) 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 31/08/2026 National ethics and scientific committee
Ethics Committee Address
Street address City Postal code Country
Off Waiyaki Way Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 31/08/2026 National Ethics Committee for Health Reseach
Ethics Committee Address
Street address City Postal code Country
Aime Cesaire Street Dakar 4024 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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). 12 months
Secondary Outcome Proportion of clinical trial participants with a TEAE, receiving at least one dose of study treatment 12 months
Secondary Outcome 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 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Centre Hospitalier National Dalal Jamm Route des Niayes Dakar 19.001 Senegal
The Centre for Sickle Cell Disease Research and Outpatient Treatment St-Louis. ouverte en 1990 Dakar 234 Senegal
Lodwar County Referral Hospital Lokichoggio Road Lodwar 18-30500 Kenya
Kacheliba Sub county Hospital Along Alale Road Kacheliba 50 30601, Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Health Innovative Technology 1-9-10 RoppongiMinato-ku Tokyo 106 0032 Japan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Drug for Neglected Diseases Intiative 15 Chemin Camille-Vidart Geneva 1202 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Borna Nyaoke bnyaoke@dndi.org +254205003400 One padmore Road
City Postal code Country Position/Affiliation
Nairobi 21936 005 Kenya Mycetoma Disease Head
Role Name Email Phone Street address
Scientific Enquiries Samuel Tesema stesema@dndi.org +254205003400 One Padmore Place
City Postal code Country Position/Affiliation
Nairobi 21936005 Kenya Project Lead
Role Name Email Phone Street address
Public Enquiries Linet Otieno latieno@dndi.org +254205003400 One Padmore Place
City Postal code Country Position/Affiliation
Nairobi 21936 005 Kenya Head of Communications
Role Name Email Phone Street address
Principal Investigator Jane Ongango jongango@kemri.go.ke +254722733829 Raila Odinga Road
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Research Scientist
Role Name Email Phone Street address
Principal Investigator Doudou Sow doudou.sow@ugb.edu.sn +221775425028 Nationale 2 route de Ngallele BP 234
City Postal code Country Position/Affiliation
Saint Louis Senegal Head of Departement of Parasitology and Mycology University of Gaston Berger in St Louis
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes DNDi will need to share this data with its subcontractors, partners, and other researchers. Participant information may travel to faraway countries. DNDi will ensure participant information is shared properly and identity is kept confidential. Clinical Study Report 3 years Managed access for a request coming from scientific team and Regulators
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.dndi.org No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 22/07/2026 Typo Secondary Outcome, Proportion of clinical trial participants with a TEAE, receiving at least one dose of study treatment , 24 months Secondary Outcome, Proportion of clinical trial participants with a TEAE, receiving at least one dose of study treatment , 12 months
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/07/2026 Was missed in initial submission Principal Investigator, Doudou, Sow, Prof., doudou.sow@ugb.edu.sn, , +221775425028, Nationale 2 route de Ngallele BP 234 , Saint Louis , , Senegal, Head of Departement of Parasitology and Mycology University of Gaston Berger in St Louis