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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Completed

Conditions

Graft Versus Host Disease

Hematopoietic Stem Cell Transplantation

Treatments

Procedure: Optimization cohort

Procedure: Control cohort

Study type

Observational

Funder types

Other

Identifiers

NCT03727113

Optimbioma

Details and patient eligibility

About

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.

Enrollment

211 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.