Optimization of Antibiotic Treatment in Hematopoietic Stem Cell Receptors

NCT03727113 | Completed

• 1 other identifier: Optimbioma
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

microbiota; microbiome; graft versus host disease; infection; antibiotics

Outcome Measures

Primary Outcomes (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).

  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)

• Incidence of Acute graft versus host disease

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

• Transplant related mortality

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

• Mortality caused by infection

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

• Incidence of severe infections

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

• Overall survival

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

Study Arms (2)

Control cohort

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

Procedure: Control cohort

Optimization cohort

Patients receiving an allogeneic hemopoietic stem cell transplant in Centers using an optimization/antibiotic strategy.

Procedure: Optimization cohort

Interventions

Optimization cohort PROCEDURE

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

Optimization cohort

Control cohort PROCEDURE

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

Control cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Grupo Espanol de trasplantes hematopoyeticos y terapia celular: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (5)

Virgen del Rocío University Hospital, Seville.

Seville, Seville, 41013, Spain

Location

Gregorio Marañón University Hospital

Madrid, 28007, Spain

Location

Salamanca University Hospital

Salamanca, 37007, Spain

Location

Marqués de Valdecilla University Hospital

Santander, 39008, Spain

Location

University Clinical Hospital of Valencia

Valencia, 46010, Spain

Location

Related Publications (3)

• 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.

  PMID: 29153975 BACKGROUND

• 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.

  PMID: 24323983 BACKGROUND

• 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.

  PMID: 32690735 DERIVED

Biospecimen

Stool samples

MeSH Terms

Conditions

Graft vs Host Disease; Infections

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Ildefonso Espigado, PhD, MD

  Hematology Service, Hematopoietic Transplant Program, Seville Biomedicine Institute (IBIS) - Virgen del Rocío University Hospital, Seville.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 1, 2018
• Study Start: January 16, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

ES (5)