A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)

NCT ID: NCT01598311

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-16
• Study Completion Date: 2015-08-25

Brief Summary

A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CB-183,315

Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days.

Group Type: EXPERIMENTAL

CB-183,315

Intervention Type: DRUG

CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.

Placebo

Intervention Type: DRUG

Placebo size 00 opaque hard gelatin capsules.

Vancomycin

Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.

Interventions

CB-183,315

CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.

Intervention Type: DRUG

Vancomycin

Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.

Intervention Type: DRUG

Placebo

Placebo size 00 opaque hard gelatin capsules.

Intervention Type: DRUG

Other Intervention Names

Surotomycin

Eligibility Criteria

Inclusion Criteria

• Is able to read and sign a consent form;
• Is from ≥18 to <90 years of age;
• Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;
• Tests positive for Clostridium difficile;
• If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.

Exclusion Criteria

• Has toxic megacolon and/or known small bowel ileus;
• Has received treatment with intravenous immune globulin (IVIG) within the past 30 days;
• Has received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;
• Has received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;
• Has received an investigational vaccine against Clostridium difficile;
• Has received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;
• Has more than 2 episodes of CDAD within 90 days;
• Has had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months (this does not include appendectomy or cholecystectomy);
• Has a history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;
• Is unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
• Is unable to discontinue opiate treatment unless on a stable dose;
• Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
• Has had stool studies positive for pathogenic ova and/or parasites;
• Has an intolerance or hypersensitivity to daptomycin and/or vancomycin;
• Has a life-threatening illness at the time of enrollment;
• Has poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;
• Has received an investigational drug or participated in any experimental procedure within 1 month;
• Has human immunodeficiency virus (HIV), a cluster of differentiation (CD) 4 count <200 cells/mm^3 within 6 months of start of study therapy;
• Anticipates that certain antibacterial therapy for a non-CDAD infection will be required for >7 days;
• Is unable to discontinue Saccharomyces or similar probiotic;
• Is on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
• Is unable to comply with the protocol requirements;
• Has any condition that, in the opinion of the Investigator, might interfere;
• Is not expected to live for less than 8 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Daley P, Louie T, Lutz JE, Khanna S, Stoutenburgh U, Jin M, Adedoyin A, Chesnel L, Guris D, Larson KB, Murata Y. Surotomycin versus vancomycin in adults with Clostridium difficile infection: primary clinical outcomes from the second pivotal, randomized, double-blind, Phase 3 trial. J Antimicrob Chemother. 2017 Dec 1;72(12):3462-3470. doi: 10.1093/jac/dkx299.

Reference Type: RESULT

PMID: 28961905 (View on PubMed)

Cheknis A, Devaris D, Chesnel L, Dale SE, Nary J, Sambol SP, Citron DM, Goering RV, Johnson S. Characterization of Clostridioides difficile isolates recovered from two Phase 3 surotomycin treatment trials by restriction endonuclease analysis, PCR ribotyping and antimicrobial susceptibilities. J Antimicrob Chemother. 2020 Nov 1;75(11):3120-3125. doi: 10.1093/jac/dkaa297.

Reference Type: DERIVED

PMID: 32747931 (View on PubMed)

Other Identifiers

LCD-CDAD-11-06

Identifier Type: OTHER

Identifier Source: secondary_id

MK-4261-006

Identifier Type: OTHER

Identifier Source: secondary_id

2012-000252-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

4261-006

Identifier Type: -

Identifier Source: org_study_id