Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan

PHASE2CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

May 9, 2017

Primary Completion Date

June 10, 2021

Study Completion Date

March 7, 2022

Conditions
Mycetoma
Interventions
DRUG

Fosravuconazole

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.

DRUG

Itraconazole

This will be the active comparator

Trial Locations (1)

Unknown

Mycetoma Research Centre, Khartoum

All Listed Sponsors
lead

Drugs for Neglected Diseases

OTHER

NCT03086226 - Proof-of-Concept Superiority Trial of Fosravuconazole Versus Itraconazole for Eumycetoma in Sudan | Biotech Hunter | Biotech Hunter