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. 2023 Apr 25;2023(4):CD013871. doi: 10.1002/14651858.CD013871.pub2

NCT03970200.

Study name PMT for severe‐CDI
Methods Randomized, open label, comparative, phase 2 study
Participants Inclusion criteria

  1. ≥ 1 episodes of CDI with symptoms including bowel movements altered in frequency or consistency from baseline

  2. Stool test positive for C difficile by EIA by FDA‐cleared assay within 7 days prior to enrollment

  3. Age ≥ 18 years

  4. Meets any 1 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 Infectious Diseases Society of America guidelines


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/μL) or severe (ANC < 500 cells/μL) neutropenia

  4. Known food allergy that could lead to anaphylaxis

  5. Pregnancy. For people of childbearing potential (ages 18–55 years), the participant must have a negative urine pregnancy test within 48 hours of consent and ≤ 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
Interventions Intervention

  1. FMT, suspension product (Penn Microbiome Therapy – 002)

  2. FMT, enema product (Penn Microbiome Therapy – 003)


Comparison

  1. Antibiotics; standard of care antibiotics
Outcomes Primary outcome

  1. Resolution of symptoms after treatment with 1 of the Penn Microbiome Therapy suite of products. The outcome will be satisfied when the subject is discharged from the hospital (not to hospice or palliative care) or, while the subject remains hospitalized, when the following criteria are met for 72 hours: if radiology study or studies performed, ileus/dilation/megacolon either not noted or noted as resolved; ileus/megacolon either noted as resolved by any provider documentation or not noted; WBC < 15,000 cells/μL; serum creatinine decreased, unchanged, or increased by ≤ 0.2 mg/dL over 72 hours (if not receiving continuous renal replacement therapy or hemodialysis); lactate ≤ 2.2 mmol/L (if measured by clinical care team); no vasopressors used (including epinephrine, norepinephrine, phenylephrine, or vasopressin); temperature < 38.5 °C and ≥ 35.6 °C; < 8 bowel movements per day and < 600 mL unformed stool (if volume recorded); meeting < 3 systemic inflammatory response syndrome criteria (time frame: 7 days)


Secondary outcomes

  1. Incidence of treatment‐emergent AEs as assessed using CTCAE V5.0: all‐cause mortality at 30‐ and 60‐days following last FMT; colectomy or diverting ileostomy within 30 days after last FMT; cumulative days of hospitalization from enrollment until 30 days after FMT; cumulative days in ICU from enrollment until 30 days after last FMT; bacteremia from enrollment until 30 days after last FMT; repeat hospital admission within 60 days of discharge from index hospitalization

  2. Frequency SAEs assessed using CTCAE V5.0 (time frame: 180 days)

  3. Frequency of AEs of special interest assessed using CTCAE V5.0 (time frame: 180 days)

  4. Frequency solicited AEs assessed using CTCAE V5.0 (time frame: 180 days)
Starting date 16 January 2020
Contact information Brendan J Kelly MD, Hospital of the University of Pennsylvania
Notes Estimated enrollment: 90
Still recruiting