Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla211 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

211

Conditions

Hematopoietic Stem Cell Transplantation Graft Versus Host Disease

Interventions

Optimization cohort

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients admitted to receive their first allogeneic hematopoietic transplant as a treatment of any disease. * Conformity of the patient to participate by signing the informed consent. * Patients who have received a previous autologous transplant are not excluded. Exclusion Criteria: * Non-compliance of the patient to sign the informed consent. * Patients who have already started the conditioning (or thereafter) will not be included. * Allograft recipients who have previously received the transplant will not be included. Second allogeneic transplants are excluded.

Locations (5)

Virgen del Rocío University Hospital, Seville.

Seville, Seville, Spain

Gregorio Marañón University Hospital

Madrid, Spain

Salamanca University Hospital

Salamanca, Spain

Marqués de Valdecilla University Hospital

Santander, Spain

University Clinical Hospital of Valencia

Valencia, Spain

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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