Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients

NCT03030248 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO00028749
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will randomized hematology oncology patients with active diarrhea and a NAAT positive/toxin EIA negative to either 14 days of oral vancomycin capsules or placebo. The study is designed to include 30 patients (15 per arm). Outcomes will include C. difficile load using qPCR, VRE loads, structural and functional microbiome changes and frequency of bowel movements. All endpoints will be measured at several time points including days 0, 14, 21 and 90.

Conditions

Clostridium Difficile Infection; Hematologic Diseases; Oncologic Disorders; Bone Marrow Transplant

Keywords

microbiome; bone marrow transplantation; Clostridium difficile; metabolomics; vancomycin

Outcome Measures

Primary Outcomes (1)

• Changes in Clostridium Difficile Bacterial Loads in the Stool

  Changes in Clostridium difficile bacterial counts from stool as determined by quantitative polymerase chain reaction (PCR). Values obtained from initial sample (pre-treatment) were compared with values from the last sample obtained for each patient.

  First sample versus last stool sample collected, up to 90 days

Study Arms (2)

Vancomycin treated group

ACTIVE COMPARATOR

This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.

Drug: Vancomycin Oral Capsule

Placebo group

PLACEBO COMPARATOR

This group will be given placebo oral capsules every 6 hours for 14 days.

Drug: Placebo Oral Capsule

Interventions

Vancomycin Oral Capsule DRUG

We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.

Also known as: Vancocin hydrochloride Oral Capsule

Vancomycin treated group

Placebo Oral Capsule DRUG

A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD\&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the hematology oncology inpatient units at Froedtert Memorial Lutheran Hospital
• New onset of diarrhea during hospitalization
• C. difficile clinical testing showing NAAT positive EIA negative results

You may not qualify if:

• Being unable to consent for self
• Inability to take enteral medications
• Unwillingness to enroll in study
• Patient has a documented allergy to vancomycin
• Patient has a documented life expectancy shorter than treatment course (14 days)
• Patient is unwilling or unable to provide stool samples in the outpatient setting after discharge
• Diagnosis of C. difficile colitis \[NAAT (+) and toxin EIA (+) within 3 months of enrollment).
• New onset of abdominal distention within 24 hours prior to the onset of diarrhea during index admission
• Presence of toxic megacolon
• Presence of clinical sepsis. Sepsis will be defined as a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score of 2 points or more as per 2016 definitions
• Pregnancy or lactating

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (8)

• Lessa FC, Winston LG, McDonald LC; Emerging Infections Program C. difficile Surveillance Team. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Jun 11;372(24):2369-70. doi: 10.1056/NEJMc1505190. No abstract available.

  PMID: 26061850 BACKGROUND

• Martin JS, Monaghan TM, Wilcox MH. Clostridium difficile infection: epidemiology, diagnosis and understanding transmission. Nat Rev Gastroenterol Hepatol. 2016 Apr;13(4):206-16. doi: 10.1038/nrgastro.2016.25. Epub 2016 Mar 9.

  PMID: 26956066 BACKGROUND

• Theriot CM, Koenigsknecht MJ, Carlson PE Jr, Hatton GE, Nelson AM, Li B, Huffnagle GB, Z Li J, Young VB. Antibiotic-induced shifts in the mouse gut microbiome and metabolome increase susceptibility to Clostridium difficile infection. Nat Commun. 2014;5:3114. doi: 10.1038/ncomms4114.

  PMID: 24445449 BACKGROUND

• Theriot CM, Bowman AA, Young VB. Antibiotic-Induced Alterations of the Gut Microbiota Alter Secondary Bile Acid Production and Allow for Clostridium difficile Spore Germination and Outgrowth in the Large Intestine. mSphere. 2016 Jan 6;1(1):e00045-15. doi: 10.1128/mSphere.00045-15. eCollection 2016 Jan-Feb.

  PMID: 27239562 BACKGROUND

• Sethi AK, Al-Nassir WN, Nerandzic MM, Bobulsky GS, Donskey CJ. Persistence of skin contamination and environmental shedding of Clostridium difficile during and after treatment of C. difficile infection. Infect Control Hosp Epidemiol. 2010 Jan;31(1):21-7. doi: 10.1086/649016.

  PMID: 19929371 BACKGROUND

• Aldrete SD, Kraft CS, Magee MJ, Chan A, Hutcherson D, Langston AA, Greenwell BI, Burd EM, Friedman-Moraco R. Risk factors and epidemiology of Clostridium difficile infection in hematopoietic stem cell transplant recipients during the peritransplant period. Transpl Infect Dis. 2017 Feb;19(1):10.1111/tid.12649. doi: 10.1111/tid.12649.

  PMID: 27943501 RESULT

• Isaac S, Scher JU, Djukovic A, Jimenez N, Littman DR, Abramson SB, Pamer EG, Ubeda C. Short- and long-term effects of oral vancomycin on the human intestinal microbiota. J Antimicrob Chemother. 2017 Jan;72(1):128-136. doi: 10.1093/jac/dkw383. Epub 2016 Oct 5.

  PMID: 27707993 RESULT

• Polage CR, Gyorke CE, Kennedy MA, Leslie JL, Chin DL, Wang S, Nguyen HH, Huang B, Tang YW, Lee LW, Kim K, Taylor S, Romano PS, Panacek EA, Goodell PB, Solnick JV, Cohen SH. Overdiagnosis of Clostridium difficile Infection in the Molecular Test Era. JAMA Intern Med. 2015 Nov;175(11):1792-801. doi: 10.1001/jamainternmed.2015.4114.

  PMID: 26348734 RESULT

MeSH Terms

Conditions

Clostridium Infections; Hematologic Diseases

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: L. Silvia Munoz-Price, MD, PhD Enterprise Epidemiologist Professor of Medicine
• Organization: Medical College of Wisconsin

smunozprice@mcw.edu

414-955-0483

Study Officials

• Silvia Munoz-Price, M.D., Ph.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The allocation status of patients within this study will be held in sealed envelopes by the unblinded research pharmacist on the team. Neither the main care provider, study physicians, or the patient will know of their group, until either the end of the study (after data analysis). We will also have a blinded pharmacist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be divided into two groups, one receiving oral vancomycin capsules, the other receiving oral placebo capsules.

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 24, 2017
• Study Start: June 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)