An observational study in Hematopoietic Stem Cell Transplantation and Graft Versus Host Disease, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Completed at 5 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
There are data suggesting that the reduction of the diversity of intestinal microbiota caused by the used treatments in the setting of allogeneic hemopoietic stem cell transplant (ASCT), and specially antibiotics, may be related to increased incidence of graft versus host disease (GVHD) and worst clinical outcomes. Present "European Conference on Infections in Leukaemia" guidelines exhort to antibiotic treatment optimization in hematological patients, without excluding ASCT receptors. This study aims to demonstrate that in ASCT receptors a predefined protocol of optimization of the antibacterial treatment will preserve the intestinal microbiota diversity which will correlate with decrease incidence of acute GVHD. And that this procedure is safe because it will not worsen the incidence of infections, transplant related mortality, infectious mortality or global survival.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 211 is above the median of 94 across 102 observational studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
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Adult patients (> 18 years old) who are going to receive their first hematopoietic allogeneic transplant of any modality and who sign the informed consent to participate in this study will be included.
Exclusion Criteria:
Patients receiving an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics.
Procedure: Control cohort
Patients receiving an allogeneic hemopoietic stem cell transplant in Centers using an optimization/antibiotic strategy.
Procedure: Optimization cohort
Recipients of an allogeneic hemopoietic stem cell transplant in Centers using an optimization/antibiotic strategy.
Recipients of an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics.
Impact on microbiota
Comparison of biological alpha and beta diversity of the intestinal microbiota of both study groups (classical and optimized antibiotherapy). Calculation of alpha diversity (OTUs richness and Shannon diversity indexes observed, Faith's Phylogenetic Diversity and Evenness) and beta diversity (Jaccard distance, Bray-Curtis distance, Unweighted UniFra distance, used for comparing biological communities) indexes by QIIME 2 (microbiome bioinformatics platform).
Time frame: From the Previous Day of starting conditioning treatment until the last documented day of antibiotherapy or hospital discharge, whichever came first, assessed up to one month post-transplant.
Incidence of Acute graft versus host disease
Comparison of the incidence of any degree, degree-II and degree-III/IV of acute graft versus host disease between the groups of patients with high and low diversity in their microbiota. Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test.
Time frame: From the day of transplant (Day 0) to Day +100 posttransplant
Transplant related mortality
Comparison of transplant related mortality between both study groups (classical and optimized antibiotherapy). Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test.
Time frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
Mortality caused by infection
Comparison of infection related mortality between both study groups (classical and optimized antibiotherapy. Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test.
Time frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
Incidence of severe infections
Comparison of the incidence of severe infections between both study groups (classical and optimized antibiotherapy). Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test.
Time frame: From the day of transplant (Day 0) to Day +30 posttransplant
Overall survival
Comparison of overall survival between both study groups (classical and optimized antibiotherapy) Kaplan-Meier curve estimation. Test for the comparison of groups: Log-Rank Test.
Time frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
Disease free survival
Comparison of the diseae free survival between both study groups (classical and optimized antibiotherapy Kaplan-Meier curve estimation. Test for the comparison of groups: Log-Rank Test.
Time frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla