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| Name | Class |
|---|---|
| Grupo Espanol de trasplantes hematopoyeticos y terapia celular | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control cohort | Patients receiving 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimization cohort | Procedure | Recipients of an allogeneic hemopoietic stem cell transplant in Centers using an optimization/antibiotic strategy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute graft versus host disease | Comparison of the incidence of any degree, degree-II and degree-III/IV of acute graft versus host disease between the groups of patients with high and low diversity in their microbiota. Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test. | From the day of transplant (Day 0) to Day +100 posttransplant |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ildefonso Espigado, PhD, MD | Hematology Service, Hematopoietic Transplant Program, Seville Biomedicine Institute (IBIS) - Virgen del Rocío University Hospital, Seville. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virgen del Rocío University Hospital, Seville. | Seville | Seville | 41013 | Spain | ||
| Gregorio Marañón University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29153975 | Background | 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. | |
| 24323983 |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D007239 | Infections |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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Stool samples
| Control cohort | Procedure | Recipients of an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics. |
|
| Transplant related mortality | Comparison of transplant related mortality between both study groups (classical and optimized antibiotherapy). Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test. | From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant |
| Mortality caused by infection | Comparison of infection related mortality between both study groups (classical and optimized antibiotherapy. Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test. | From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant |
| Incidence of severe infections | Comparison of the incidence of severe infections between both study groups (classical and optimized antibiotherapy). Cumulative Incidence curve estimation. Test for the comparison of groups: Gray Test. | From the day of transplant (Day 0) to Day +30 posttransplant |
| Overall survival | Comparison of overall survival between both study groups (classical and optimized antibiotherapy) Kaplan-Meier curve estimation. Test for the comparison of groups: Log-Rank Test. | From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant |
| Disease free survival | Comparison of the diseae free survival between both study groups (classical and optimized antibiotherapy Kaplan-Meier curve estimation. Test for the comparison of groups: Log-Rank Test. | From the day of transplant (Day 0) to Days +30, +100 and +365 posttransplant |
| Madrid |
| 28007 |
| Spain |
| Salamanca University Hospital | Salamanca | 37007 | Spain |
| Marqués de Valdecilla University Hospital | Santander | 39008 | Spain |
| University Clinical Hospital of Valencia | Valencia | 46010 | Spain |
| 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. |
| 32690735 | Derived | 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. |