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出境医 / 临床实验 / Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Study Description
Brief Summary:
This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).

Condition or disease Intervention/treatment Phase
Recurrent Clostridium Difficile Infection Drug: Penn Microbiome Therapy - 001 Drug: Penn Microbiome Therapy - 002 Drug: Penn Microbiome Therapy - 003 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open label, comparative
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Single dose of PMT Drug: Penn Microbiome Therapy - 001
Fecal Microbiota for Transplant, enema product
Other Name: PMT-001

Drug: Penn Microbiome Therapy - 002
Fecal Microbiota for Transplant, suspension product
Other Name: PMT-002

Drug: Penn Microbiome Therapy - 003
Fecal Microbiota for Transplant, capsule product
Other Name: PMT-003
Experimental: Two doses of PMT
Administered within 24 hours
 Drug: Penn Microbiome Therapy - 001
Fecal Microbiota for Transplant, enema product
Other Name: PMT-001

Drug: Penn Microbiome Therapy - 002
Fecal Microbiota for Transplant, suspension product
Other Name: PMT-002

Drug: Penn Microbiome Therapy - 003
Fecal Microbiota for Transplant, capsule product
Other Name: PMT-003
Outcome Measures
Primary Outcome Measures :
  1. Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products or control. [ Time Frame: 8 weeks ]
    Clinical outcome will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT.


Secondary Outcome Measures :
  1. Number of subjects with resolution of symptoms in relation to the amount of drug product administered versus the quantitative culture the drug product. [ Time Frame: 8 weeks ]
  2. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  3. Frequency of solicited adverse events (AEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  4. Frequency of serious adverse events (SAEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  5. Frequency of AEs of special interest (AESIs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
  2. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
  3. At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
  4. Age ≥ 18 years.
  5. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.

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. Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate > 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include heart rate > 90 beats per minute, respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg, temperature >38ºC or <36ºC, WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms).
  7. Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.
Contacts and Locations

Contacts
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Contact: Brenden J Kelly, MD, MS (215) 662-6932 brendank@pennmedicine.upenn.edu
Contact: Lauren Dutcher, MD (215) 662-6932 dutcherl@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the Univeristy of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brendan J Kelly, MD, MS    215-662-6932    brendank@pennmedicine.upenn.edu   
Contact: Lauren Dutcher, MD    2156626932    dutcherl@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Ebbing Lautenbach, MD, MPH, MSCE University of Pennsylvania
Tracking Information
First Submitted Date  ICMJE April 17, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date December 3, 2020
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019) 		Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products or control. [ Time Frame: 8 weeks ]
Clinical outcome will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Number of subjects with resolution of symptoms in relation to the amount of drug product administered versus the quantitative culture the drug product. [ Time Frame: 8 weeks ]
  • Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  • Frequency of solicited adverse events (AEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  • Frequency of serious adverse events (SAEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  • Frequency of AEs of special interest (AESIs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
Official Title  ICMJE A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection
Brief Summary This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, open label, comparative
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Clostridium Difficile Infection
Intervention  ICMJE
  • Drug: Penn Microbiome Therapy - 001
    Fecal Microbiota for Transplant, enema product
    Other Name: PMT-001
  • Drug: Penn Microbiome Therapy - 002
    Fecal Microbiota for Transplant, suspension product
    Other Name: PMT-002
  • Drug: Penn Microbiome Therapy - 003
    Fecal Microbiota for Transplant, capsule product
    Other Name: PMT-003
Study Arms  ICMJE
  • Experimental: Single dose of PMT
    Interventions:
    • Drug: Penn Microbiome Therapy - 001
    • Drug: Penn Microbiome Therapy - 002
    • Drug: Penn Microbiome Therapy - 003
  • Experimental: Two doses of PMT
    Administered within 24 hours
    Interventions:
    • Drug: Penn Microbiome Therapy - 001
    • Drug: Penn Microbiome Therapy - 002
    • Drug: Penn Microbiome Therapy - 003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
  2. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
  3. At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
  4. Age ≥ 18 years.
  5. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.

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. Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate > 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include heart rate > 90 beats per minute, respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg, temperature >38ºC or <36ºC, WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms).
  7. Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brenden J Kelly, MD, MS (215) 662-6932 brendank@pennmedicine.upenn.edu
Contact: Lauren Dutcher, MD (215) 662-6932 dutcherl@pennmedicine.upenn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973697
Other Study ID Numbers  ICMJE IRB # 832963
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ebbing Lautenbach, MD, MPH, MSCE University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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