Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors (Optimbioma)

February 16, 2023 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors: Impact on Intestinal Microbiota and in Clinical Outcomes

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Gregorio Maranon University Hospital
      • Salamanca, Spain, 37007
        • Salamanca University Hospital
      • Santander, Spain, 39008
        • Marqués de Valdecilla University Hospital
      • Valencia, Spain, 46010
        • University Clinical Hospital of Valencia
    • Seville
      • Sevilla, Seville, Spain, 41013
        • Virgen del Rocío University Hospital, Seville.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control cohort
Patients receiving an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics.
Procedure: Control cohort
Recipients of an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics.
Optimization 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on microbiota
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.
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Acute graft versus host disease
Time Frame: From the day of transplant (Day 0) to Day +100 posttransplant

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.
From the day of transplant (Day 0) to Day +100 posttransplant
Transplant related mortality
Time Frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
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.
From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
Mortality caused by infection
Time Frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
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.
From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
Incidence of severe infections
Time Frame: From the day of transplant (Day 0) to Day +30 posttransplant
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.
From the day of transplant (Day 0) to Day +30 posttransplant
Overall survival
Time Frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
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.
From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
Disease free survival
Time Frame: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant
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.
From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Ildefonso Espigado, PhD, MD, Hematology Service, Hematopoietic Transplant Program, Seville Biomedicine Institute (IBIS) - Virgen del Rocío University Hospital, Seville.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Optimbioma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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