MycetomaPhase 2NCT03086226
Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan
A Phase 2 study testing Fosravuconazole and Itraconazole in people with Mycetoma, run by Drugs for Neglected Diseases at 1 site in Sudan.
Trial summary
This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined with surgery in subjects with eumycetoma in Sudan. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Mycetoma
- What is being tested?
- Fosravuconazole and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSudan
- Study dates
- 9 May 2017to 7 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with eumycetoma caused by M. mycetomatis confirmed by PCR.
- Participants with eumycetoma requiring surgery.
- Eumycetoma lesion ≥ 2 cm and < 16 cm in diameter. Note: A lesion was defined as either one single lesion on one anatomical area or multiple lesions on one anatomical area provided that the total affected area remained within the given limits.
- Age ≥ 15 years.
- Able to comply with protocol procedures and available for follow-up.
- Written informed consent from the participant. If the participant was < 18 years old, there had to be a signed consent from a parent or legal guardian AND a written assent signed by the participant.
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- Female specific inclusion criteria:
- Negative pregnancy test.
- If women of childbearing potential (WOCBP), to use adequate contraception during the trial period until 2 months after completion of trial treatment.
Who cannot join
- Previous surgical or medical treatment for eumycetoma which included any previous antifungal treatment.
- Presence of loco-regional lymphatic extension, osteomyelitis, other bone involvement based on radiology or any pre- or co-existing condition that could have precluded evaluation of the eumycetoma. Note: The presence of bone involvement would need a different treatment with a longer duration.
- Pregnancy or lactation at screening, or intent to have become pregnant.
- Concomitant or severe diseases that could have compromised the participant follow-up or evaluation (e.g., psychiatric condition, chronic hepatitis, neutropenia, human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), diabetes mellitus or adrenocortical insufficiency).
- Severe malnutrition as defined by a body mass index (BMI) < 16 kg/m2.
- Contraindication to use itraconazole, including congestive heart failure, ventricular dysfunction, ventricular arrhythmia and negative inotropic state; Note: for a comprehensive list of contraindications and contraindicated concomitant medication refer to the package insert for itraconazole (Sporanox®);
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- Contraindication to the use of fosravuconazole;
- Pre-existing liver disease, transaminase levels > 2x the laboratory's upper limit of normal (ULN) or elevated levels of alkaline phosphatase (ALP) or bilirubin.
- Was receiving or likely to have required drugs that were either a substrate for cytochrome P450 family 3 subfamily A member 4 (CYP3A4) and/or metabolised by CYP3A4 (cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methodone and levacetylmethadol [levomethadyl] were contraindicated);
- Fridericia's corrected QT interval (QTcF) > 450 msec on any ECG known about or taken prior to trial entry.
- Familial short QT syndrome or corrected QT interval (QTc) prolongation.
- History of hypersensitivity to any azole antifungal drug.
- Participation in other CTs within a 6-month period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind Phase II Proof-of-Concept Superiority Trial of Fosravuconazole 200 mg or 300 mg Weekly Dose Versus Itraconazole 400 mg Daily, All Three Arms in Combination With Surgery, in Patients With Eumycetoma in Sudan
This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined with surgery in subjects with eumycetoma in Sudan.
There will be three arms in this study: The first arm will be Fosravuconazole 300 mg weekly, the second arm will have Fosravuconazole 200 mg weekly and the control arm is the standard treatment using itraconazole 400mg daily.
At 3 months time-point, interim analysis will be done and one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity.
Read the detailed description
Eumycetoma is a fungal disease caused by Madurella mycetomatis. The disease is chronic, granulomatous and inflammatory. It usually involves subcutaneous tissues and leads to masses and sinuses from which fungal grains are discharged. It is most probably introduced post trauma e.g. thorn prick. It is associated with major morbidity and can be disabling, disfiguring and highly stigmatizing. In advanced cases it may be fatal. Eumycetoma is most prevalent in what is known as mycetoma belt.
Current treatment modalities for eumycetoma are disappointing. The response is characterized by low cure rates, high amputation rates, high up drop out from follow up and high recurrence rates. The available drugs for the treatment of eumycetoma are expensive, potentially toxic and require a long treatment period up to 12 months. By that time the mass is well encapsulated and is removed surgically. Despite prolonged medical treatment, the causative organisms are commonly found to still be viable and can be cultured from the surgical specimen.
The objectives of this study are to determine the comparative efficacy, safety, and tolerability of Fosravuconazole versus itraconazole as first-line treatment for subjects with eumycetoma caused by Madurella mycetomatis. The primary end-point will be complete cure after 12 months treatment as evidenced by clinical assessment showing absence of mycetoma mass with closure of sinuses and absent discharge, normal ultrasonic examination of the lesion, or the presence of fibrosis only associated with a negative fungal culture from a surgical biopsy from the former mycetoma site. The secondary endpoints are the outcome at 3-month's time point based on the same criteria as 12 month and/or treatment-related adverse events at the 3- and 12-month visits. The study will also monitor plasma drug levels of ravuconazole and itraconazole that will be included in a logistic model with other clinical and laboratory parameters to predict outcome. In addition, immunological studies will be done to describe the developing or changing immune responses during treatment. Lastly, all strains collected will be cultured and typed and with assessment of antifungal resistance.
This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial in subjects with eumycetoma requiring surgery. There will be three arms this study: The first arm will have Fosravuconazole 300 mg weekly and the second arm will have Fosravuconazole 200 mg weekly. Both arms will be evaluated at 3 months. At this time-point, one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity. The control arm is the standard treatment using itraconazole 400mg daily. Patients will receive treatment for one year. An interim analysis is planned after data has been accumulated for sample size of 28 for 3 months end point.
This study will be done at the Mycetoma Research Centre, Sudan when ethics and regulatory approvals are received. The study plans to recruit 138 subjects by the end of the trial. The main inclusion criteria are subjects who provide consent, aged 18 years or more with primary moderate eumycetoma (size 2-10 cm) caused by Polymerase Chain Reaction (PCR) confirmed Madurella mycetomatis. Females in the child bearing age will require stringent contraception. The main exclusion criteria are eumycetoma > 10 cm, previous treatment, significant concomitant illness that preclude evaluation and treatments or conditions treated with drugs that are known to interact with the azoles.
The study is expected to new safer and more efficacious eumycetoma treatment.
- Conditions
- Mycetoma
- Being tested
- Fosravuconazole, Itraconazole
- Keywords
- Mycetoma Fosravuconazole Itraconazole Surgery Sudan
- Medical subject headings
- Mycetoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FosravuconazoleDrug
Also called E1224
Fosravuconazole will be given in two arms either as 300mg or 200mg. The drop-the loser design adaptive clinical trial design will allow two stages of the trial separated by a data based decision. In the first stage a decision will be taken on which arm to drop either the Fosravuconazole 200 or the Fosravuconazole 300 arm. The best treatment will be compared against the standard of care, itraconazole. At the end the focus will be comparing the best treatment against standard of care.
ItraconazoleDrug
Also called Sporanox
This will be the active comparator
| Study group | Role | What they receive |
|---|---|---|
| Fosravuconazole 300 mg | Experimental | Given throughout the study for 12 months as the experimental arm.
Both experimental arms will be evaluated at 3 months. At this time-point, one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity. Receives: Drug: Fosravuconazole |
| Fosravuconazole 200 mg weekly | Experimental | Given throughout the study for 12 months as the experimental arm.
Both experimental arms will be evaluated at 3 months. At this time-point, one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity. Receives: Drug: Fosravuconazole |
| Itraconazole 400mg daily | Active comparator | Given throughout the study for 12 months as the comparator arm. Receives: Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete cure at the End-of-Treatment
Complete cure at the End-of-Treatment (EOT; 52-week time point) in the Modified Intention to Treat (mITT) population.
Complete cure of mycetoma is defined as
- negative fungal culture from a surgical biopsy from the former mycetoma site AND
- clinical cure (no clinical evidence of mycetoma mass, sinus tract, or discharge) AND
- normal lesion site or only fibrosis on sonogram
Measured: 12 months
Secondary outcomes (15)
Proportion of patients with complete cure of the Mycetoma at the end of the study
Complete cure of the mycetoma at the End Of Study (EOS; 15 months) visits Complete cure of mycetoma is defined as
- negative fungal culture from a surgical biopsy from the former mycetoma site AND
- clinical cure (no clinical evidence of mycetoma mass, sinus tract, or discharge) AND
- normal lesion site or only fibrosis on sonogram
Measured: 15 months
Proportion of patients with mycological eradication of Mycetoma
Mycological eradication of the etiologic fungal pathogen from the mycetoma biopsy at the EOT visit (52-week time point). Mycological eradication is defined as negative Mycetoma culture biopsy.
Measured: 12 months
Proportion of patients considered to have effective treatment at the End of Treament
Effective treatment (combination of mycological eradication AND clinical improvement in the mycetoma lesion) at EOT (52-week time point) visit in the mITT and Clinically Evaluable (CE) Populations.
Mycetoma clinical improvement is defined by reduction in mycetoma mass size. Mycological eradication is defined as negative Mycetoma culture biopsy.
Measured: 12 months
Proportion of patients considered to have effective treatment at the End of Study
Effective treatment (combination of mycological eradication AND clinical improvement in the mycetoma lesion) at EOS (15 months) visit in the mITT and Clinically Evaluable (CE) Populations.
Mycetoma clinical improvement is defined by reduction in mycetoma mass size. Mycological eradication is defined as negative Mycetoma culture biopsy.
Measured: 12 months
Propoprtion of patients with complete mycetoma cure by fungus genus at End of Treatment
Complete cure, effective treatment, and overall improvement categorized by etiologic fungal genus and species at EOT (52-week time point) visits in the mITT and CE populations
Measured: 12 months
Propoprtion of patients with complete mycetoma cure by fungus genus at End of Study
Complete cure, effective treatment, and overall improvement categorized by etiologic fungal genus and species at EOS (15 months) visits in the mITT and CE populations
Measured: 15 months
Immunological changes
Immunological parameters indicating a switch from a Th2 to a Th1 response. This includes measurement of cytokines, immunoglobulins and cells
Measured: 15 months
Time to complete cure
The time to onset of cure will be calculate for each subject
Measured: 15 months
Time to effective treatment
The time to effective treatment will be calculate for each subject (combination of mycological eradication and clinical improvement in the mycetoma lesion).
Measured: 15 months
Time to failure
The time to relapse will be calculate for each subject
Measured: 15 months
The proportion of subjects experiencing at least one Adverse Event
The safety consists the description of each serious adverse event and adverse event (preferred term) per treatment group and classified by system organ. ECG and Laboratory abnormalities will be considered as Adverse Events.
Measured: 15 months
The frequency of the Adverse Events and Serious Adverse Events that lead to treatment discontinuation.
The safety consists the description of each serious adverse event and adverse event (preferred term) per treatment group and classified by system organ. ECG and Laboratory abnormalities will be considered as Adverse Events.
Measured: 15 months
Severity of the Adverse Events and Serious Adverse Events that lead to treatment discontinuation.
The safety consists the description of each serious adverse event and adverse event (preferred term) per treatment group and classified by system organ. ECG and Laboratory abnormalities will be considered as Adverse Events.
Measured: 15 months
CMax
Derived exposure parameters of ravuconazole and itraconazolecalculated from the final PK model using individual posterior estimates of the PK parameters and from dosing history.
Measured: 15 months
AUC at steady-state (AUCss)
Derived exposure parameters of ravuconazole and itraconazolecalculated from the final PK model using individual posterior estimates of the PK parameters and from dosing history.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start9 May 2017
- Primary completion10 Jun 2021
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MycetomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Fahal, Prof, Principal investigator, Mycetoma Research Centre, Soba University, Khartoum, Sudan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086226
- Sponsor's protocol ID
- DNDi-FOSR-04-MYC
- Status last verified
- Jul 2024
- First submitted
- 25 Jan 2017
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi
Publications
Chu WY, Fahal AH, Ahmed ES, Bakhiet SM, Bakhiet OE, Fahal LA, Mohamed AA, Mohamedelamin ESW, Bahar MEN, Attalla HY, Siddig EE, Mhmoud NA, Musa AM, Oyieko P, Egondi T, Bruggemann RJ, Hata K, Strub-Wourgaft N, Alves F, Nyaoke BA, Zijlstra EE, Dorlo TPC. Pharmacokinetics and Pharmacodynamics of Fosravuconazole, Itraconazole, and Hydroxyitraconazole in Sudanese Patients With Eumycetoma. J Infect Dis. 2025 Sep 15;232(3):e518-e528. doi: 10.1093/infdis/jiaf279.
PubMed 40433693Fahal AH, Ahmed ES, Bakhiet SM, Bakhiet OE, Fahal LA, Mohamed AA, Mohamedelamin ESW, Bahar MEN, Attalla HY, Siddig EE, Mhmoud NA, Musa AM, van de Sande WWJ, Scherrer B, Oyieko P, Egondi TW, Onyango KO, Hata K, Chu WY, Dorlo TPC, Bruggemann RJ, Nyaoke BA, Strub-Wourgaft N, Zijlstra EE. Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial. Lancet Infect Dis. 2024 Nov;24(11):1254-1265. doi: 10.1016/S1473-3099(24)00404-3. Epub 2024 Aug 1.
PubMed 39098321
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Phase II Proof-of-Concept Superiority Trial of Fosravuconazole 200 mg or 300 mg Weekly Dose Versus Itraconazole 400 mg Daily, All Three Arms in Combination With Surgery, in Patients With Eumycetoma in Sudan
- ClinicalTrials.gov ID
- NCT03086226
- Acronym / sponsor ID
- DNDi-FOSR-04-MYC
- Conditions
- Mycetoma
- Keywords
- Mycetoma Fosravuconazole Itraconazole Surgery Sudan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial of Fosravuconazole versus Itraconazole combined with surgery in subjects with eumycetoma in Sudan.
There will be three arms in this study: The first arm will be Fosravuconazole 300 mg weekly, the second arm will have Fosravuconazole 200 mg weekly and the control arm is the standard treatment using itraconazole 400mg daily.
At 3 months time-point, interim analysis will be done and one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity.
Detailed description
Eumycetoma is a fungal disease caused by Madurella mycetomatis. The disease is chronic, granulomatous and inflammatory. It usually involves subcutaneous tissues and leads to masses and sinuses from which fungal grains are discharged. It is most probably introduced post trauma e.g. thorn prick. It is associated with major morbidity and can be disabling, disfiguring and highly stigmatizing. In advanced cases it may be fatal. Eumycetoma is most prevalent in what is known as mycetoma belt.
Current treatment modalities for eumycetoma are disappointing. The response is characterized by low cure rates, high amputation rates, high up drop out from follow up and high recurrence rates. The available drugs for the treatment of eumycetoma are expensive, potentially toxic and require a long treatment period up to 12 months. By that time the mass is well encapsulated and is removed surgically. Despite prolonged medical treatment, the causative organisms are commonly found to still be viable and can be cultured from the surgical specimen.
The objectives of this study are to determine the comparative efficacy, safety, and tolerability of Fosravuconazole versus itraconazole as first-line treatment for subjects with eumycetoma caused by Madurella mycetomatis. The primary end-point will be complete cure after 12 months treatment as evidenced by clinical assessment showing absence of mycetoma mass with closure of sinuses and absent discharge, normal ultrasonic examination of the lesion, or the presence of fibrosis only associated with a negative fungal culture from a surgical biopsy from the former mycetoma site. The secondary endpoints are the outcome at 3-month's time point based on the same criteria as 12 month and/or treatment-related adverse events at the 3- and 12-month visits. The study will also monitor plasma drug levels of ravuconazole and itraconazole that will be included in a logistic model with other clinical and laboratory parameters to predict outcome. In addition, immunological studies will be done to describe the developing or changing immune responses during treatment. Lastly, all strains collected will be cultured and typed and with assessment of antifungal resistance.
This study is a single-center, comparative, randomized, double-blind, parallel-group, active-controlled, clinical superiority trial in subjects with eumycetoma requiring surgery. There will be three arms this study: The first arm will have Fosravuconazole 300 mg weekly and the second arm will have Fosravuconazole 200 mg weekly. Both arms will be evaluated at 3 months. At this time-point, one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity. The control arm is the standard treatment using itraconazole 400mg daily. Patients will receive treatment for one year. An interim analysis is planned after data has been accumulated for sample size of 28 for 3 months end point.
This study will be done at the Mycetoma Research Centre, Sudan when ethics and regulatory approvals are received. The study plans to recruit 138 subjects by the end of the trial. The main inclusion criteria are subjects who provide consent, aged 18 years or more with primary moderate eumycetoma (size 2-10 cm) caused by Polymerase Chain Reaction (PCR) confirmed Madurella mycetomatis. Females in the child bearing age will require stringent contraception. The main exclusion criteria are eumycetoma > 10 cm, previous treatment, significant concomitant illness that preclude evaluation and treatments or conditions treated with drugs that are known to interact with the azoles.
The study is expected to new safer and more efficacious eumycetoma treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fosravuconazole 300 mg | Experimental | Drug: FosravuconazoleGiven throughout the study for 12 months as the experimental arm. Both experimental arms will be evaluated at 3 months. At this time-point, one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity. |
| Fosravuconazole 200 mg weekly | Experimental | Drug: FosravuconazoleGiven throughout the study for 12 months as the experimental arm. Both experimental arms will be evaluated at 3 months. At this time-point, one of the study arms will be dropped according to the drop-the-loser design, based on efficacy or toxicity. |
| Itraconazole 400mg daily | Active comparator | Drug: ItraconazoleGiven throughout the study for 12 months as the comparator arm. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Participants with eumycetoma caused by M. mycetomatis confirmed by PCR.
- Participants with eumycetoma requiring surgery.
- Eumycetoma lesion ≥ 2 cm and < 16 cm in diameter. Note: A lesion was defined as either one single lesion on one anatomical area or multiple lesions on one anatomical area provided that the total affected area remained within the given limits.
- Age ≥ 15 years.
- Able to comply with protocol procedures and available for follow-up.
Key exclusion criteria (13 listed)
- Previous surgical or medical treatment for eumycetoma which included any previous antifungal treatment.
- Presence of loco-regional lymphatic extension, osteomyelitis, other bone involvement based on radiology or any pre- or co-existing condition that could have precluded evaluation of the eumycetoma. Note: The presence of bone involvement would need a different treatment with a longer duration.
- Pregnancy or lactation at screening, or intent to have become pregnant.
- Concomitant or severe diseases that could have compromised the participant follow-up or evaluation (e.g., psychiatric condition, chronic hepatitis, neutropenia, human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), diabetes mellitus or adrenocortical insufficiency).
- Severe malnutrition as defined by a body mass index (BMI) < 16 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FosravuconazoleAlso: E1224Fosravuconazole will be given in two arms either as 300mg or 200mg. The drop-the loser design adaptive clinical trial design will allow two stages of the trial separated by a data based decision. In the first stage a decision will be taken on which arm to drop either the Fosravuconazole 200 or the Fosravuconazole 300 arm. The best treatment will be compared against the standard of care, itraconazole. At the end the focus will be comparing the best treatment against standard of care. | Drug | Fosravuconazole 200 mg weekly, Fosravuconazole 300 mg |
| ItraconazoleAlso: SporanoxThis will be the active comparator | Drug | Itraconazole 400mg daily |
Primary outcome
Proportion of patients with complete cure at the End-of-Treatment
Time frame: 12 months
Complete cure at the End-of-Treatment (EOT; 52-week time point) in the Modified Intention to Treat (mITT) population. Complete cure of mycetoma is defined as 1. negative fungal culture from a surgical biopsy from the former mycetoma site AND 2. clinical cure (no clinical evidence of mycetoma mass, sinus tract, or discharge) AND 3. normal lesion site or only fibrosis on sonogram
15 secondary outcomes
Proportion of patients with complete cure of the Mycetoma at the end of the study
Time frame: 15 months
Proportion of patients with mycological eradication of Mycetoma
Time frame: 12 months
Proportion of patients considered to have effective treatment at the End of Treament
Time frame: 12 months
Proportion of patients considered to have effective treatment at the End of Study
Time frame: 12 months
Propoprtion of patients with complete mycetoma cure by fungus genus at End of Treatment
Time frame: 12 months
Propoprtion of patients with complete mycetoma cure by fungus genus at End of Study
Time frame: 15 months
Immunological changes
Time frame: 15 months
Time to complete cure
Time frame: 15 months
Time to effective treatment
Time frame: 15 months
Time to failure
Time frame: 15 months
The proportion of subjects experiencing at least one Adverse Event
Time frame: 15 months
The frequency of the Adverse Events and Serious Adverse Events that lead to treatment discontinuation.
Time frame: 15 months
Severity of the Adverse Events and Serious Adverse Events that lead to treatment discontinuation.
Time frame: 15 months
CMax
Time frame: 15 months
AUC at steady-state (AUCss)
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 40433693Chu WY, Fahal AH, Ahmed ES, Bakhiet SM, Bakhiet OE, Fahal LA, Mohamed AA, Mohamedelamin ESW, Bahar MEN, Attalla HY, Siddig EE, Mhmoud NA, Musa AM, Oyieko P, Egondi T, Bruggemann RJ, Hata K, Strub-Wourgaft N, Alves F, Nyaoke BA, Zijlstra EE, Dorlo TPC. Pharmacokinetics and Pharmacodynamics of Fosravuconazole, Itraconazole, and Hydroxyitraconazole in Sudanese Patients With Eumycetoma. J Infect Dis. 2025 Sep 15;232(3):e518-e528. doi: 10.1093/infdis/jiaf279.
- Derived from this study: PubMed 39098321Fahal AH, Ahmed ES, Bakhiet SM, Bakhiet OE, Fahal LA, Mohamed AA, Mohamedelamin ESW, Bahar MEN, Attalla HY, Siddig EE, Mhmoud NA, Musa AM, van de Sande WWJ, Scherrer B, Oyieko P, Egondi TW, Onyango KO, Hata K, Chu WY, Dorlo TPC, Bruggemann RJ, Nyaoke BA, Strub-Wourgaft N, Zijlstra EE. Two dose levels of once-weekly fosravuconazole versus daily itraconazole in combination with surgery in patients with eumycetoma in Sudan: a randomised, double-blind, phase 2, proof-of-concept superiority trial. Lancet Infect Dis. 2024 Nov;24(11):1254-1265. doi: 10.1016/S1473-3099(24)00404-3. Epub 2024 Aug 1.
- Individual participant dataSharing planned: Yes. Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Fahal, Prof principal investigator
Mycetoma Research Centre, Soba University, Khartoum, Sudan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosravuconazole and Itraconazole in people with Mycetoma, run by Drugs for Neglected Diseases at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete cure at the End-of-Treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086226, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.