Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

211 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-16

Study Completion Date

2021-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Hematopoietic Stem Cell Transplantation Graft Versus Host Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control cohort

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

Control cohort

Intervention Type PROCEDURE

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.

Optimization cohort

Intervention Type PROCEDURE

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

Interventions

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Optimization cohort

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

Intervention Type PROCEDURE

Control cohort

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No