Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

PHASE3CompletedINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

July 31, 2017

Primary Completion Date

April 2, 2020

Study Completion Date

August 3, 2020

Conditions
Clostridium Difficile Infection (CDI)
Interventions
DRUG

RBX2660

RBX2660 is a rectally administered microbiota suspension

DRUG

Placebo

Placebo is normal saline solution administered rectally

DRUG

Open label RBX2660 (only for confirmed CDI recurrence)

RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660

Trial Locations (66)

10016

New York, New York

11758

North Massapequa, North Massapequa

14618

Rochester, Rochester

15401

Uniontown, Uniontown

19031

Flourtown, Flourtown

19102

Philadelphia, Philadelphia

19610

Wyomissing, Wyomissing

22150

Springfield, Springfield

22601

Winchester, Winchester

27710

Durham, Durham

27834

Greenville, Greenville

28401

Wilmington, Wilmington

29425

Charleston, Charleston

30322

Atlanta, Atlanta

30342

Atlanta, Atlanta

32127

Port Orange, Port Orange

32224

Jacksonville, Jacksonville

32610

Gainesville, Gainesville

33176

Miami, Miami

35611

Athens, Athens

36305

Dothan, Dothan

37434

Hixson, Hixson

40536

Lexington, Lexington

43608

Toledo, Toledo

47904

Lafayette, Lafayette

48202

Detroit, Detroit

53792

Madison, Madison

54449

Marshfield, Marshfield

55446

Plymouth, Plymouth

55902

Rochester, Rochester

57701

Rapid City, Rapid City

58102

Fargo, Fargo

60031

Gurnee, Gurnee

60035

Highland Park, Highland Park

60153

Maywood, Maywood

63110

St. Louis, St Louis

66606

Topeka, Topeka

67214

Wichita, Wichita

68198

Omaha, Omaha

70121

New Orleans, New Orleans

71105

Shreveport, Shreveport

72117

North Little Rock, North Little Rock

75246

Dallas, Dallas

77030

Houston, Houston

80045

Aurora, Aurora

83404

Idaho Falls, Idaho Falls

84088

West Jordan, West Jordan

85054

Phoenix, Phoenix

89106

Las Vegas, Las Vegas

90095

Los Angeles, Los Angeles

93030

Oxnard, Oxnard

93534

Lancaster, Lancaster

95817

Sacramento, Sacramento

97701

Portland, Portland

98104

Seattle, Seattle

06518

Hamden, Hamden

02114

Boston, Boston

68198-4031

Omaha, Omaha

07666

Teaneck, Teaneck

19107-5244

Philadelphia, Philadelphia

T2N2T9

Calgary, Calgary

TG2X8

Edmonton, Edmonton

V5Z1M9

Vancouver, Vancouver

BC V8R 1J8

Victoria, Victoria

E3B 4R3

Fredericton, Fredericton

E1C628

Moncton, Moncton

All Listed Sponsors
lead

Rebiotix Inc.

INDUSTRY

NCT03244644 - Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3) | Biotech Hunter | Biotech Hunter