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

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ClinicalTrials.gov Identifier: NCT03727113
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 13, 2018
Sponsor:
Collaborators:
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:
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.

Condition or disease Intervention/treatment
Hematopoietic Stem Cell Transplantation Graft Versus Host Disease Procedure: Optimization cohort Procedure: Control cohort

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors: Impact on Intestinal Microbiota and in Clinical Outcomes
Actual Study Start Date : January 16, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Biospecimen Description:
Stool samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727113


Contacts
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Contact: Ildefonso Espigado, PhD, MD 0034 697966979 ildefonso.espigado.sspa@juntadeandalucia.es
Contact: Clara M Rosso-Fernández, PhD, MD 0034 955012144 claram.rosso.sspa@juntadeandalucia.es

Locations
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Spain
Virgen del Rocío University Hospital, Seville. Recruiting
Sevilla, Seville, Spain, 41013
Contact: Ildefonso Espigado, PhD, MD    0034 697966979    ildefonso.espigado.sspa@juntadeandalucia.es   
Contact: Nancy Rodríguez, PhD, MD    0034 955 01 2228    nanarotor@hotmail.com   
Gregorio Marañón University Hospital Recruiting
Madrid, Spain, 28007
Contact: Mi Kwon, MD    0034 915868443    mi.kwon@salud.madrid.org   
Salamanca University Hospital Recruiting
Salamanca, Spain, 37007
Contact: María L Vazquez Lopez, MD       lvazlo@usal.es   
Marqués de Valdecilla University Hospital Recruiting
Santander, Spain, 39008
Contact: Lucrecia Yáñez, MD    0034 942 202573    lucrecia@humv.es   
University Clinical Hospital of Valencia Recruiting
Valencia, Spain, 46010
Contact: Carlos Solano Vercet, MD       carlos.solano@uv.es   
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Ildefonso Espigado, PhD, MD Hematology Service, Hematopoietic Transplant Program, Seville Biomedicine Institute (IBIS) - Virgen del Rocío University Hospital, Seville.

Publications:
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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03727113    
Other Study ID Numbers: Optimbioma
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
microbiota
microbiome
graft versus host disease
infection
antibiotics
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents