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Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

NCT03727113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 211

Last updated 2023-02-17

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Optimization cohort

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

PROCEDURE

Control cohort

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

Sponsors & Collaborators

  • Grupo Espanol de trasplantes hematopoyeticos y terapia celular

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Ildefonso Espigado, PhD, MD · Hematology Service, Hematopoietic Transplant Program, Seville Biomedicine Institute (IBIS) - Virgen del Rocío University Hospital, Seville.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727113 on ClinicalTrials.gov