Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan (NCT03086226) | Clinical Trial Compass
CompletedPhase 2
Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan
Sudan104 participantsStarted 2017-05-09
Plain-language 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.
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.
Who can participate
Age range15 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Female specific inclusion criteria:
✓. Negative pregnancy test.
Exclusion criteria
✕. Previous surgical or medical treatment for eumycetoma which included any previous antifungal treatment.
What they're measuring
1
Proportion of patients with complete cure at the End-of-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®);
✕. 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.