PMT for Severe-CDI
Severe Clostridium Difficile Infection, Severe-Complicated/Fulminant Clostridium Difficile Infection
About this trial
This is an interventional treatment trial for Severe Clostridium Difficile Infection
Eligibility Criteria
Inclusion Criteria:
- 1. One or more episodes of CDI with symptoms including bowel movements altered in frequency or consistency from baseline.
- 2. Stool test positive for Clostridium difficile by EIA by FDA-cleared assay within 7 days prior to enrollment.
- 3. Age ≥ 18 years
- 4. Meets any one of the listed criteria for severe or severe-complicated/fulminant disease within 72 hours of enrollment.
- 5. Receiving antibiotic treatment for S/SC/F-CDI per current IDSA guidelines.
Enrollment criteria details:
- 1. Must either meet ≥1 criteria in severe category or in severe complicated category to be enrolled
- 2. If the subject meets criteria in both categories, stratify to the higher severity category (severe complicated)
- 3. Detailed enrollment criteria definitions:
- a. WBC ≥15,000 cells/uL - if any value in the time period meets this definition
- b. Hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring vasopressors (epinephrine, norepinephrine, phenylephrine, or vasopressin)
- c. Acute kidney injury - increase in serum creatinine level by ≥50% or new dialysis initiation
- i. If a baseline serum creatinine value is not available, acute kidney injury will be defined as a serum creatinine >1.5 mg/dL
- d. Temperature ≥38.5 °C or <35.6°C - one value needed in time period -
- e. Ileus, bowel dilation or megacolon
- i. Ileus: If noted in any provider documentation or problem list (search words "ileus") OR
- ii. If the words "dilated" "dilation" or "ileus" are noted in a radiology report on intestines/colon, or if "megacolon" noted
- f. Lactate >2.2 mmol/L - if any value in the time period meets this definition
- g. SIRS criteria
- i. Heart rate > 90 beats per minute
- ii. Respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg
- iii. Temperature >38ºC or <36ºC
- iv. WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms
Exclusion Criteria:
- 1. Evidence of colon/small bowel perforation at the time of study screening.
- 2. Goals of care are directed to comfort rather than curative measures.
- 3. Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.
- 4. Known food allergy that could lead to anaphylaxis.
- 5. Pregnancy
- a. For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration.
- 6 Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.
- 7 COVID-19 infection, as defined by a positive nucleic acid or antigen test within the prior 14 days and symptoms consistent with COVID-19 infection
Sites / Locations
- Hospital of the Univeristy of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
No investigational product
Upper gastrointestinal Fecal Microbiota Transplantation
Lower gastrointestinal Fecal Microbiota Transplantation
Participants who receive the antibiotics usually prescribed for C diff infection.
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).