Infection With Multi-drug Resistant Organisms
Conditions
Keywords
infection, colonization, antibiotic resistance
Brief summary
This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of likely enteric origin. FMT will be performed on subjects with a history of at least three recurrent infections due to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or at least two recurrent infections due to MDRO for which only antimicrobials with rate limiting toxicities are available. The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will be able to prevent additional recurrences of infections due to MDRO by suppressing or reversing enteric colonization with MDRO.
Detailed description
This is a prospective pilot study of fecal microbiota transplantation in patients with a history of recurrent MDRO infections. Subjects who meet inclusion/exclusion criteria and provide written, informed consent will provide a pre-FMT stool sample. The FMT will be administered by enema in the outpatient setting by trained personnel. Patients will provide stool samples 30 days, 6 months, and 12 months post-FMT. The subjects will also be monitored for potential adverse events, recurrence of MDRO infections, infections that may be related to FMT, and worsening of existing comorbidities or development of new comorbidities.
Interventions
BIOLOGICALFecal microbiota transplantation (FMT)
Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
will include: * Age ≥18 years old. * Outpatient status at time of FMT. * History of at least three recurrent infections due to an MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or at least two recurrent infections due to MDRO for which only antimicrobials with rate limiting toxicities (see above) are available AND the MDRO is likely of enteric origin. Only MDROs of likely enteric origin will be included. * Be without active infection due to the MDRO at the time of FMT. * Not be receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT.
Exclusion criteria
will include: * Subjects \<18 years old. * Subjects unable to be seen as an outpatient. * Use of enteral or systemic antimicrobials at time of FMT. * Planned use of enteral or systemic antimicrobials up to 6 months post-FMT. * Pregnancy or inability/unwillingness to use contraceptives. * Recent intra-abdominal surgery * Short gut syndrome * Gastrointestinal motility disorders * Use of medications that affect intestinal motility an inability to cease using those medications at the time of FMT. * Post-allogeneic hematopoietic stem cell transplant recipients with previous or current gastrointestinal graft versus host disease. * ANC \<500/mm3 * HIV+ and not well controlled on antiretroviral therapy, or CD4+ \<200/ mm3 * At increased risk for peritonitis: presence of intra-abdominal devices, receiving peritoneal dialysis, or ascites. * Any acute illness * Recurrent C. difficile infection. * Unlikely to survive for 3 months. * Investigator feels the risks of FMT outweigh potential benefit, including other conditions or medications that the investigator determines puts the subject at greater risk from FMT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) | 12 months post-FMT | Incidence and severity of solicited and serious adverse events within 12 months of FMT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) | 30 days, 6 months, and 12 months post-FMT | Number of subjects with MDRO infections 30 days, 6 months, and 12 months post-FMT. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fecal Microbiota Transplantation Subjects will receive 150mL of fecal microbiota product via enema.
Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Fecal Microbiota Transplantation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 1 / 1 |
Outcome results
Primary
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events)
Incidence and severity of solicited and serious adverse events within 12 months of FMT.
Time frame: 12 months post-FMT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fecal Microbiota Transplantation | Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) | Solicited adverse events related to FMT | 0 Participants |
| Fecal Microbiota Transplantation | Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) | Any serious adverse event | 1 Participants |
Secondary
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections)
Number of subjects with MDRO infections 30 days, 6 months, and 12 months post-FMT.
Time frame: 30 days, 6 months, and 12 months post-FMT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fecal Microbiota Transplantation | MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) | MDRO infection at 12 months | 0 Participants |
| Fecal Microbiota Transplantation | MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) | MDRO infection at 30 days | 0 Participants |
| Fecal Microbiota Transplantation | MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) | MDRO infection at 6 months post-FMT | 1 Participants |