Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

PHASE2RecruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

June 2, 2025

Primary Completion Date

February 29, 2028

Study Completion Date

February 29, 2028

Conditions
Ototoxicity, Drug-Induced
Interventions
DRUG

ORC-13661

High-dose intervention (30mg daily)

DRUG

ORC-13661

Low-dose intervention (12mg daily)

DRUG

Placebo

Placebo intervention

Trial Locations (5)

29425

NOT_YET_RECRUITING

Medical University of South Carolina, Charleston

55905

RECRUITING

Mayo Clinic, Rochester

75708

RECRUITING

University of Texas Health Science Center, Tyler

80206

RECRUITING

National Jewish Health, Denver

97239

RECRUITING

Oregon Health & Science University, Portland

Sponsors
All Listed Sponsors
collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

collaborator

Oricula Therapeutics

UNKNOWN

collaborator

University of Washington

OTHER

collaborator

National Jewish Health

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

The University of Texas Health Science Center at Tyler

OTHER

collaborator

Medical University of South Carolina

OTHER

lead

Kevin Winthrop

OTHER

NCT05730283 - Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin | Biotech Hunter | Biotech Hunter