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Hematopoietic Stem Cell TransplantationOptimbiomaNCT03727113

Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

An observational study of Hematopoietic Stem Cell Transplantation and Graft Versus Host Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Optimization cohort
Type of treatment
Surgery or procedure
How many people
211 participants
Where
5 sitesSpain
Study dates
16 Jan 2018to 30 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Gregorio Marañón University Hospital

    Madrid, 28007

  • Salamanca University Hospital

    Salamanca, 37007

  • Marqués de Valdecilla University Hospital

    Santander, 39008

  • Virgen del Rocío University Hospital, Seville.

    Seville, Seville, 41013

  • University Clinical Hospital of Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: 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.

Being tested
Optimization cohort, Control cohort
Keywords
microbiota, microbiome, graft versus host disease, infection, antibiotics
Medical subject headings
Graft vs Host Disease, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimization cohortProcedure or surgery

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

  • Control cohortProcedure or surgery

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

Study groups in NCT03727113
Study groupRoleWhat they receive
Control cohortPatients receiving an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics.
Receives: Procedure: Control cohort
Optimization cohortPatients receiving an allogeneic hemopoietic stem cell transplant in Centers using an optimization/antibiotic strategy.
Receives: Procedure: Optimization cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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 (6)

  1. 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.

    Measured: From the day of transplant (Day 0) to Day +100 posttransplant

  2. 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.

    Measured: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant

  3. 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.

    Measured: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant

  4. 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.

    Measured: From the day of transplant (Day 0) to Day +30 posttransplant

  5. 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.

    Measured: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant

  6. 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.

    Measured: From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2018
  2. Study start16 Jan 2018
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03727113
Sponsor's protocol ID
Optimbioma
Acronym
Optimbioma
Status last verified
Feb 2023
First submitted
16 Oct 2018
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Aguilar-Guisado M, Espigado I, Martin-Pena A, Gudiol C, Royo-Cebrecos C, Falantes J, Vazquez-Lopez L, Montero MI, Rosso-Fernandez C, de la Luz Martino M, Parody R, Gonzalez-Campos J, Garzon-Lopez S, Calderon-Cabrera C, Barba P, Rodriguez N, Rovira M, Montero-Mateos E, Carratala J, Perez-Simon JA, Cisneros JM. Optimisation of empirical antimicrobial therapy in patients with haematological malignancies and febrile neutropenia (How Long study): an open-label, randomised, controlled phase 4 trial. Lancet Haematol. 2017 Dec;4(12):e573-e583. doi: 10.1016/S2352-3026(17)30211-9. Epub 2017 Nov 15.

    PubMed 29153975

  • Averbuch D, Orasch C, Cordonnier C, Livermore DM, Mikulska M, Viscoli C, Gyssens IC, Kern WV, Klyasova G, Marchetti O, Engelhard D, Akova M; ECIL4, a joint venture of EBMT, EORTC, ICHS, ESGICH/ESCMID and ELN. European guidelines for empirical antibacterial therapy for febrile neutropenic patients in the era of growing resistance: summary of the 2011 4th European Conference on Infections in Leukemia. Haematologica. 2013 Dec;98(12):1826-35. doi: 10.3324/haematol.2013.091025.

    PubMed 24323983

  • Jimenez-Jorge S, Labrador-Herrera G, Rosso-Fernandez CM, Rodriguez-Torres N, Pachon-Ibanez ME, Smani Y, Marquez-Malaver FJ, Limon Ramos C, Solano C, Vazquez-Lopez L, Kwon M, Mora Barrios JM, Aguilar-Guisado M, Espigado I; GETH (Grupo Espanol de Trasplante Hematopoyetico y Terapia Celular). Assessing the impact on intestinal microbiome and clinical outcomes of antibiotherapy optimisation strategies in haematopoietic stem cell transplant recipients: study protocol for the prospective multicentre OptimBioma study. BMJ Open. 2020 Jul 20;10(7):e034570. doi: 10.1136/bmjopen-2019-034570.

    PubMed 32690735

Questions about this trial

What is this clinical trial studying?

An observational study of Hematopoietic Stem Cell Transplantation and Graft Versus Host Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03727113, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.

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