PMT for Severe-CDI
PMT for Severe-CDI
This is a randomized, open label, comparative, Phase II study to determine whether fecal
 microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat
 severe Clostridium difficile infection (C diff).
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 24 hours of intervention.

 -  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