Clinical trial · Interventional
Vancomycin for C Difficile NAAT+/EIA- Hematology Oncology Patients
Randomized Double Blind Controlled Trial for the Treatment of Nucleic Acid Amplification Test (NAAT)+/Toxin Enzyme Immunoassay (EIA)- Clostridium Difficile in the Hematology Oncology Population
NCT03030248CI-TRIAL-00108367completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Transplant | — | UNRESOLVED | — |
| Clostridium Difficile Infection | — | UNRESOLVED | — |
| Hematologic Diseases | — | UNRESOLVED | — |
| Oncologic Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Oral Capsule | Drug | — | UNRESOLVED |
| Vancomycin Oral Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vancomycin treated group
- description
- This group will be given vancomycin oral capsules, 125 mg, every 6 hours, for 14 days.
- interventionNames
- Drug: Vancomycin Oral Capsule
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- This group will be given placebo oral capsules every 6 hours for 14 days.
- interventionNames
- Drug: Placebo Oral Capsule
Primary outcomes (1)
- measure
- Changes in Clostridium Difficile Bacterial Loads in the Stool
- timeFrame
- First sample versus last stool sample collected, up to 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (8)
- BACKGROUNDLessa 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
- BACKGROUNDMartin 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
- BACKGROUNDTheriot 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
- BACKGROUNDTheriot 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
- BACKGROUNDSethi 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
- RESULTAldrete 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
- 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.