Infection Due to Resistant Organism Clinical Trial
— PREMIXOfficial title:
A Pilot Study Using Fecal Microbiota Transplant in Renal Transplant Recipients to Eliminate Multidrug-Resistant Organism Colonization After Infection and Examine Gastrointestinal Carriage in a Randomized Placebo-Controlled Design
Verified date | November 2023 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who have infections with resistant bacteria will be given a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic treatment. This study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics. This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant patients to support the rationale for a subsequent clinical trial, not to establish efficacy or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes, assess feasibility, and refine the target population in participants with MDRO colonization and intestinal dysbiosis. Data from this study should provide directions for the design of future clinical trials.
Status | Terminated |
Enrollment | 11 |
Est. completion date | December 3, 2021 |
Est. primary completion date | December 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ability to understand and willingness to sign a written informed consent document. - Ability and willingness to comply with study protocol requirements and receive an enema. - History of MDRO infection with at least one of the following target MDROs: CRE, VRE, ESBL, or MDR Pseudomonas. - Prior receipt of a renal transplant. - If applicable, willingness to discontinue probiotics or other microbiota restoration therapies during screening at least seven days prior to study Day 1. - The effects of FMT on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. - Negative blood or urine human chorionic gonadotropin (hCG) testing on the day of FMT for WOCBP with documentation of negative test result. - Negative baseline Human Immunodeficiency Virus (HIV) test. - Known serology CMV status confirmed by Medical History (if positive). If no mention of positivity in medical records, serology is tested within 30 days of enrollment for: - Cytomegalovirus (CMV) by polymerase chain reaction (PCR) - Cytomegalovirus (CMV), serology Immunoglobulin G (IgG) Exclusion Criteria: - Female participants who are pregnant, breastfeeding, lactating, or planning a pregnancy during study duration (through 4 weeks after the last dose of investigational product). - Prior gastrointestinal surgery or intervention: - Ileostomy (in the last 3 months) - Colostomy (in the last 3 months) - Gastric or colon resection (in the last 3 months) - Bariatric surgery (any prior history) - Total colectomy (any prior history) - Any of the following gastrointestinal conditions: - Irritable Bowel Syndrome (IBS) with diarrhea in the last 12 months - Crohn's disease - Ulcerative Colitis - Celiac disease - Untreated in-situ colorectal cancer - Microscopic colitis - Toxic megacolon or ileus - Tube feeding (current or planned) - Known positive stool studies or cultures in the last 30 days for: Ova or parasites, Salmonella, Shigella, Campylobacter - Other enteropathogens - defined as any positive result other than C. difficile on the Biofire FilmArray gastrointestinal panel, (Campylobacter, Plesiomonas, Salmonella, Vibrio, Yersinia, Enteroaggregative Escherichia coli (EAEC), Enteropathogenic Escherichia coli (EPEC), Enterotoxigenic Escherichia coli (ETEC), Shigella, Cryptosporidium, Cyclospora, Entamoeba, Giardia, Adenovirus, Astrovirus, Norovirus, Rotavirus, Sapovirus). - Known uncontrolled intercurrent illness(es) such as, but not limited to: - Ongoing or active infection - Symptomatic congestive heart failure - Acute coronary syndrome - Cardiac arrhythmia - Any other intercurrent acute illness that in the opinion of the investigator will preclude subject from entering the study - On systemic antibiotics for any reason other than recent MDRO infection. If a potential participant is taking antibiotics for treatment (not prophylaxis) of MDRO infection, then the participant must complete the planned antibiotic course by study Day -2. - Compromised immune system other than transplant immunosuppression: - HIV-positive as identified by one of the following: Positive HIV test, prior diagnosis of HIV, or active or history of administration of antiretroviral therapy (ART) other than for pre-exposure prophylaxis or post-exposure prophylaxis. - Known Absolute Neutrophil (ANC) <1000 neutrophils per cubic millimeter (mm^3) in the last 3 months - Active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment either concurrently or in the last 2 months - Acute leukemia - History of hematopoietic cell transplantation, either allogeneic or autologous in the last 3 years - History of solid organ transplant rejection in the last 6 months - Significant food allergy to foods that are part of the stool donor participant's diet. - Life expectancy is 24 weeks or less. - Any condition that, in the opinion of the investigator, might interfere with study objectives or limit compliance with study requirements, including but not limited to: - Known active intravenous drug or alcohol abuse - Psychiatric illness - Social situation - Participated in an investigational study that also meets one of the following criteria: - Received an interventional agent (drug, device, or procedure) in the last 28 days - Enrollment on this study or any other interventional study for MDROs |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Cepheid |
United States,
Woodworth MH, Conrad RE, Haldopoulos M, Pouch SM, Babiker A, Mehta AK, Sitchenko KL, Wang CH, Strudwick A, Ingersoll JM, Philippe C, Lohsen S, Kocaman K, Lindner BG, Hatt JK, Jones RM, Miller C, Neish AS, Friedman-Moraco R, Karadkhele G, Liu KH, Jones DP, — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Adverse Events | The safety and feasibility of using FMT in adult participants with Target MDRO colonization after infection will be measured by comparing the number of adverse events (assessed by CTCAE v4.0) after Day 1 of each cycle as compared to baseline. | Up to 30 weeks | |
Primary | Change in Target MDRO Growth | The primary outcome is target MDRO growth on perirectal swab or stool culture on Day 36 of each cycle compared Screening and Day 1 culture results. Participants will be classified as having a complete response, partial response, refractory response or progression based on their Day 36 culture results. Partial response, refractory response, and progression may be collapsed in a non-response category for analytic purposes. | Day 1, Up to 30 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02816437 -
FMT for MDRO Colonization in Solid Organ Transplant
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Phase 1 | |
No longer available |
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