Antimicrobial resistance (carbapenem resistant Enetrobacteriales and/or extended spectrum beta-lactamase producing Enterobacteriales) Infections and Infestations
Conditions
Interventions
For the active arm, participants will be dosed with lyophilised faecal microbiota derived from 100g of stool and encapsulated in five coloured delayed release methylcellulose. The dose is repeated for
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 20/07/2020: 1. Adult patients (age 18 years or older at time of consent) 2. Current or previous patient at Guy’s and St Thomas’ NHS Foundation Trust 3. Ability to understand the purpose, potential benefits, and risks of the study and capable of giving informed consent. The participant must be able to provide written informed consent. 4. Documented gastrointestinal carriage of ESBL or CPE (stool sample) in the 21 days prior to consent. 5. Symptomatic infection with the same target organism of interest in the preceding 6 months Previous participant inclusion criteria: 1. Adult patients (age >18 years at time of randomisation) 2. Current or previous patient at Guy’s and St Thomas’ NHS Foundation Trust 3. Ability to understand the purpose, potential benefits and risks of the study and capable of giving informed consent. The participant must be able to provide written informed consent 4. Documented gastrointestinal carriage of ESBL or CPE (rectal swab or stool sample) within 21 days of randomisation 5. Symptomatic infection with the same target organism of interest in the preceding 6 months
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 20/07/2020: 1. Pregnancy or planned pregnancy. Urine testing will be performed at screening to rule out pregnancy 2. Breastfeeding 3. Severe or life-threatening food allergy 4. Allergy or other contraindication to omeprazole, IMP or placebo ingredients 5. Treatment with systemic antibiotic on the day prior to 1st IMP/placebo dosing to the end of the dosing period 6. Treatment with pre or probiotics in the 4 weeks prior to randomisation and for the duration of the study 7. Severe immunodeficiency 7.1. Systemic chemotherapy 60 mg daily for > 30 days) within 8 weeks of randomisation 8. Life expectancy 60 mg daily for > 30 days) within 8 weeks of randomisation 8. Life expectancy <6 months 9. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication 10. Patients who have received another investigational drug or device within 30 days prior to randomisation 11. Any condition or circumstance, in the opinion of the investigator, that would compromise the safety of the patient or the quality of the study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consent rate (%) of eligible patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/03/2020: 1. Proportion of patients fulfilling inclusion / exclusion criteria at endline 2. Proportion of patients receiving IMP / placebo (as a % of those consenting) at endline 3. Proportion of patients returning for follow up visits (face to face visit at Day 40) 4. Proportion of patients providing follow up stool samples (Days 10, 40, 100, 190) 5. Ability to recruit sufficient healthy donors to manufacture all FMT doses to meet demands of this and a future substantive RCT. Assessed by delay in dosing patients (measured in days) at end of study 6. Collection of data that may be used in estimating of costs/resources needed to provide FMT in the NHS at end of study 7. An embedded qualitative study to explore views and experiences of research participants. 8. Gastrointestinal carriage of CRE / ESBL (detected / not detected) by stool culture over time (days 10, 40, 100 and 190) 9. Gastrointestinal carriage of CRE / ESBL (detected / not detected) by multiplex PCR over time (days 10, 40, 100 and 190) 10. Proportion of patients experiencing reflux following administration of FMT at each dosing day (days 1,2,3) and follow up visit 1(day 10) 11. Proportion of patients suffering intolerable (resulting in withdrawal from the study) gastrointestinal side effects (including diarrhoea, constipation, abdominal pain, flatulence and bloating). This will be assessed by direct questioning and completion of a short patient questionnaire at each dosing day (days 1,2,3) and follow up visit 1(day 10) 12. Identification of unanticipated harms involved with administration of FMT at each dosing day (days 1,2,3) and follow up visits days 10, 40, 100 and 190 13. Occurrence of any adverse drug reaction at each dosing day (days 1,2,3) and follow up visits days 10, 40, 100 and 190 14. Occurrence of any adverse event/serious adverse event at each dosing day (days 1,2,3) and follow up visits days 10, 40, 100 and 190 _____ Previous secondary outcome mea | — |
Countries
England, United Kingdom
Outcome results
None listed