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NCT Number: NCT03727113

Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Graft Versus Host Disease Graft vs Host Disease Immune System Diseases Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virgen del Rocío University Hospital, Seville., Seville, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optimization cohort

Procedure

Recipients of an allogeneic hemopoietic stem cell transplant in Centers using an optimization/antibiotic strategy.

Control cohort

Procedure

Recipients of an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Optimbioma

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2018
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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