NCT03727113

Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 211 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Hematopoietic Stem Cell Transplantation
• Graft Versus Host Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-16
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-11-01
• Last updated: 2023-02-17

Locations

5 sites across 1 country: Spain