CARRIER STATE Clinical Trial
— PROFTMDECOLOfficial title:
Open-label, Randomized Study to Assess the Efficacy of a Probiotic or Fecal Microbiota Transplantation (FMT) on the Eradication of Rectal Multidrug-resistant Gram-negative Bacilli (MDR-GNB) Carriage (PROFTMDECOL)
The working hypothesis is that in patients who are rectal carriers of MDR-GNB (Multi drug-resistant gram negative bacilli), the rate and speed of eradication of the carrier status obtained with NAA regimens are insufficient and could be improved with additional interventions directed to restore a healthy fecal microbiota or to increase the colonization resistance by the putative beneficial activity of lactate-producing bacteria and bifidobacteria. A healthier colonic microbiota environment is expected not only to promote the eradication of the existing MDR organisms but also to hinder the subsequent recolonization and hopefully the risk of infection with gut dysbiosis -associated pathogens (MDR-GNB, C. difficile and Candida). The principal objective of the study is To compare the decolonization efficacy at the end of the study (60 ± 7 days after randomization) of the administration of a probiotic ("Vivomixx®" 2 sachets/12h for 2 weeks) versus the administration of two doses (administered a week apart) of a fecal microbiota transplantation preparation (equivalent to 50 g of healthy donor feces) and no treatment (control arm) in patients with rectal colonization with MDRGNB (ESBL-producing Klebsiella pneumoniae, CPE and MDR/XDR (multi drug-resistant/ extensively drug-resistant Pseudomonas aeruginosa).
Status | Recruiting |
Enrollment | 437 |
Est. completion date | July 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adult patients (=18 years-old). 2. Admitted to the Hospital Clinic of Barcelona with documented rectal colonization whitin the previous 7 days by rectal swabbing with MDR-GNB (ESBL-producing Klebsiella pneumoniae, carbapenemase-producing Enterobacterial (CPE) and MDR/XDR Pseudomonas aeruginosa). 3. Eligible for routine digestive decolonization (7 days oral administration of nonabsorbable antibiotics (NAA). 4. Capable to provide informed consent (by themselves or through their legal representatives). Exclusion Criteria: 1. Pregnant women or breastfeeding. 2. Neutropenic patients (total neutrophil count <500 cell/mm3)*. 3. HIV-infected patients with CD4(cluster of differentiation 4) count <200 cell/mm3. 4. Patients with active C. difficile infection. 5. Patients with ileus or bowel obstruction. 6. Patients with documented or suspected bowel perforation. 7. Patients with a colistin-resistant MDR-GNB. - Solid organ or hematopoietic organ transplant recipients without neutropenia will qualify for inclusion in the study. This is based on preliminary data on the safety of probiotics without Saccharomyces boulardii/cerevisae in transplant recipients of several organs (hematopoietic precursors, liver, kidney, small intestine) and on the preliminary safety data of FMT in nonneutropenic patients with hematological disorders including hematopoietic cell transplantation (25,42,43). However, the condition of transplant recipients will be assessed inan individual basis and only those patients that by consensus with their attending physician will be judged to be at a very low risk of complications derived from the use of the probiotic o fecal microbiota will be considered for inclusion in the study. |
Country | Name | City | State |
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Spain | Hospital Clinic | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Fondo de Investigacion Sanitaria, Fundacion Clinic per a la Recerca Biomédica, Institut d'Investigacions Biomèdiques August Pi i Sunyer |
Spain,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with digestive decolonization rate | Proportion of patients with digestive decolonization rate defined as negative rectal swab (RS) for the target MDR-GNB (ESBL-producing Klebsiella pneumoniae, CPE and MDR/XDR Pseudomonas aeruginosa) at the end of study (60 ± 7 days after the randomization). | At the end of study (60 ± 7 days after the randomization). | |
Secondary | Digestive decolonization rate defined as a negative fecal sample | Proportion of patients with digestive decolonization rate defined as a negative fecal sample for the target MDR-GNB at the end of study treatment (3 weeks after randomization). | At the end of study treatment (3 weeks after randomization). | |
Secondary | Digestive decolonization rate defined as a negative rectal swab | Proportion of patients with digestive decolonization rate defined as a negative rectal swab for the target MDR-GNB after the decontamination period with non-absorbable antibiotics (week 1 after randomization). | (week 1 after randomization). | |
Secondary | target MDR-GNB or any other MDR-GNB in any control RS or fecal sample | Proportion of patients with target MDR-GNB or any other MDR-GNB in any control RS or fecal sample during the study period. | through study completion, an average of 1 year | |
Secondary | clinical infections | Proportion of patients with clinical infections during the study period. | through study completion, an average of 1 year | |
Secondary | development of resistance to colistin or amikacin | Proportion of patients with development of resistance to colistin or amikacin in any strain isolated in control RS or fecal sample during the study period. | through study completion, an average of 1 year | |
Secondary | Changes in fecal microbiota composition | Changes from baseline in fecal microbiota composition at the end of study treatment. | At the end of study treatment (3 weeks after randomization). |
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