Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase

PHASE3TerminatedINTERVENTIONAL
Enrollment

259

Participants

Timeline

Start Date

December 20, 2019

Primary Completion Date

September 9, 2022

Study Completion Date

September 9, 2022

Conditions
Staphylococcus Aureus BacteremiaStaphylococcus Aureus Endocarditis
Interventions
DRUG

Exebacase

Participants will receive a single IV infusion of exebacase in addition to SoCA selected by the investigator. Participants with normal renal function or mild renal impairment will be administered a dose of 18 mg; participants with moderate or severe renal impairment will be administered a dose of 12 mg of exebacase; participants with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg of exebacase.

DRUG

Placebo

Participants will receive a single IV infusion of placebo in addition to SoCA selected by the investigator.

Trial Locations (55)

10029

Cf 301-105, New York

10595

Cf 301-105, Valhalla

18103

Cf 301-105, Allentown

19104

Cf 301-105, Philadelphia

19107

Cf 301-105, Philadelphia

19611

CF 301-105 Investigator Site, West Reading

20010

Cf 301-105, Washington D.C.

20037

Cf 301-105, Washington D.C.

21201

Cf 301-105, Baltimore

21224

Cf 301-105, Baltimore

27599

Cf 301-105, Chapel Hill

27710

Cf 301-105, Durham

27834

CF-301-105 Study Site, Greenville

28203

Cf 301-105, Charlotte

30033

Cf 301-105, Decatur

30322

Cf 301-105, Atlanta

30912

Cf 301-105, Augusta

32608

Cf 301-105, Gainesville

35294

Cf 301-105, Birmingham

37232

Cf 301-105, Nashville

38103

Cf 301-105, Memphis

38105

Cf 301-105, Memphis

43210

CF-301-105 Study Site, Columbus

43608

Cf 301-105, Toledo

46804

Cf 301-105, Fort Wayne

48073

Cf 301-105, Royal Oak

48202

Cf 301-105, Detroit

53226

Cf 301-105, Milwaukee

55905

Cf 301-105, Rochester

59701

CF-301-105 Study Site, Butte

60026

Cf 301-105, Glenview

60035

Cf 301-105, Highland Park

60153

Cf 301-105, Maywood

60637

CF-301-105 Investigator Site, Chicago

63110

Cf 301-105, St Louis

65212

CF-301-105 Study Site, Columbia

66160

Cf 301-105, Kansas City

68124

Cf 301-105, Omaha

68198

Cf 301-105, Omaha

77030

Cf 301-105, Houston

83404

CF-301-105 Study Site, Idaho Falls

84108

CF-301-105 Study Site, Salt Lake City

90502

Cf 301-105, Torrance

91342

CF-301-105 Investigator Site, Sylmar

92037

Cf 301-105, San Diego

92868

CF-301-105 Study Site, Orange

95817

Cf 301-105, Sacramento

06102

CF-301-105 Study Site, Hartford

06510

Cf 301-105, New Haven

02215

CF 301-105 Study Site, Boston

01805

CF-301-105 Study Site, Burlington

01605

Cf 301-105, Worcester

07753

Cf 301-105, Neptune City

07102

Cf 301-105, Newark

05401

Cf 301-105, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ContraFect

INDUSTRY