FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safety
Abstract Background Multidrug-resistant Gram-negative bacterial (MRGNB) infections represent a major public health threat. Cancer patients and, among them, hematological patients are most vulnerable to these infections. Gut colonization by MRGNB is a common phenomenon occurring during hospitalizatio...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07702-5 |
| _version_ | 1797647170212462592 |
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| author | Ainhoa Fernández Moreno Lucía Lavín-Alconero Paula López de Ugarriza Laura Solán Blanco Sara Cáceres Hernández Juan Miguel Bergua Burgués María Izquierdo de Miguel Ana Julia González Huerta Marta Polo Zarzuela Blanca Boluda Karem Humala Maria Luisa Calabuig Maria Luz Amigo Marián Cuesta Casas María del Mar García-Saiz Ana Fernández Verdugo Javier Fernández Domínguez Teresa Bernal |
| author_facet | Ainhoa Fernández Moreno Lucía Lavín-Alconero Paula López de Ugarriza Laura Solán Blanco Sara Cáceres Hernández Juan Miguel Bergua Burgués María Izquierdo de Miguel Ana Julia González Huerta Marta Polo Zarzuela Blanca Boluda Karem Humala Maria Luisa Calabuig Maria Luz Amigo Marián Cuesta Casas María del Mar García-Saiz Ana Fernández Verdugo Javier Fernández Domínguez Teresa Bernal |
| author_sort | Ainhoa Fernández Moreno |
| collection | DOAJ |
| description | Abstract Background Multidrug-resistant Gram-negative bacterial (MRGNB) infections represent a major public health threat. Cancer patients and, among them, hematological patients are most vulnerable to these infections. Gut colonization by MRGNB is a common phenomenon occurring during hospitalization and chemotherapy exposure. In the neutropenic phase that occurs after chemotherapy, MRGNB translocation occurs increasing patient’s mortality. Fluoroquinolone prophylaxis with ciprofloxacin or levofloxacin efficacy is now being questioned due to the increase of incidence in MRGNB. Methods A phase III randomized, controlled, clinical trial, open-label parallel-group with a 1:1 ratio, aimed to demonstrate the non-inferiority of oral fosfomycin versus oral ciprofloxacin for febrile neutropenia prevention in patients with acute leukemia (AL) or hematopoietic cell transplant (HSC) receptors. Weekly surveillance cultures are planned to detect gut colonization. Changes in fecal microbiome at the beginning and end of prophylaxis will also be analyzed. Discussion This trial will provide evidence of the efficacy of an alternative drug to ciprofloxacin for febrile neutropenia prevention in high-risk hematological patients. The battery of planned microbiological studies will allow us to evaluate prospectively the microbiological safety of both pharmacological strategies in terms of the selection of MRGNB occurring in each arm. In addition, valuable information on the way in which each drug changes the fecal microbiome of the patients throughout the treatment will be generated. Trial registration Clinical trials NCT05311254, Registered on 5 April 2022, https://clinicaltrials.gov/ct2/show/NCT05311254?term=FOVOCIP&cntry=ES&draw=2&rank=1 . Protocol version: 3.0, dated 20 May 2022. |
| first_indexed | 2024-03-11T15:12:29Z |
| format | Article |
| id | doaj.art-20bda6816b664445ab85f8c0fdf8ed31 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-11T15:12:29Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-20bda6816b664445ab85f8c0fdf8ed312023-10-29T12:35:50ZengBMCTrials1745-62152023-10-0124111310.1186/s13063-023-07702-5FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safetyAinhoa Fernández Moreno0Lucía Lavín-Alconero1Paula López de Ugarriza2Laura Solán Blanco3Sara Cáceres Hernández4Juan Miguel Bergua Burgués5María Izquierdo de Miguel6Ana Julia González Huerta7Marta Polo Zarzuela8Blanca Boluda9Karem Humala10Maria Luisa Calabuig11Maria Luz Amigo12Marián Cuesta Casas13María del Mar García-Saiz14Ana Fernández Verdugo15Javier Fernández Domínguez16Teresa Bernal17Hematology Department, University Hospital Central of AsturiasClinical Trials Agency Valdecilla-IDIVAL, Marqués de Valdecilla University HospitalHematology Department, University Hospital Central of AsturiasHematology Department, Fundación Jiménez DíazHematology Department, San Pedro Alcántara HospitalHematology Department, San Pedro Alcántara HospitalHematology Department, San Pedro Alcántara HospitalHematology Department, University Hospital Central of AsturiasHematology Department, University Clinic Hospital San CarlosHematology Department, Instituto de Investigación, University Hospital La FeHematology Department, University Hospital La PazHematology Department, University Clinic Hospital of ValenciaHematology Department, University Hospital Morales MesseguerHematology Department, University Hospital Carlos HayaClinical Trials Agency Valdecilla-IDIVAL, Marqués de Valdecilla University HospitalMicrobiology Department, University Hospital Central of AsturiasClinical Trials Agency Valdecilla-IDIVAL, Marqués de Valdecilla University HospitalInstituto Universitario de Oncología del Principado de Asturias, C/ Fernando BongeraAbstract Background Multidrug-resistant Gram-negative bacterial (MRGNB) infections represent a major public health threat. Cancer patients and, among them, hematological patients are most vulnerable to these infections. Gut colonization by MRGNB is a common phenomenon occurring during hospitalization and chemotherapy exposure. In the neutropenic phase that occurs after chemotherapy, MRGNB translocation occurs increasing patient’s mortality. Fluoroquinolone prophylaxis with ciprofloxacin or levofloxacin efficacy is now being questioned due to the increase of incidence in MRGNB. Methods A phase III randomized, controlled, clinical trial, open-label parallel-group with a 1:1 ratio, aimed to demonstrate the non-inferiority of oral fosfomycin versus oral ciprofloxacin for febrile neutropenia prevention in patients with acute leukemia (AL) or hematopoietic cell transplant (HSC) receptors. Weekly surveillance cultures are planned to detect gut colonization. Changes in fecal microbiome at the beginning and end of prophylaxis will also be analyzed. Discussion This trial will provide evidence of the efficacy of an alternative drug to ciprofloxacin for febrile neutropenia prevention in high-risk hematological patients. The battery of planned microbiological studies will allow us to evaluate prospectively the microbiological safety of both pharmacological strategies in terms of the selection of MRGNB occurring in each arm. In addition, valuable information on the way in which each drug changes the fecal microbiome of the patients throughout the treatment will be generated. Trial registration Clinical trials NCT05311254, Registered on 5 April 2022, https://clinicaltrials.gov/ct2/show/NCT05311254?term=FOVOCIP&cntry=ES&draw=2&rank=1 . Protocol version: 3.0, dated 20 May 2022.https://doi.org/10.1186/s13063-023-07702-5Hematological neoplasmsFebrile neutropeniaProphylaxisGram-negative resistant bacteriaRandomized controlled trial |
| spellingShingle | Ainhoa Fernández Moreno Lucía Lavín-Alconero Paula López de Ugarriza Laura Solán Blanco Sara Cáceres Hernández Juan Miguel Bergua Burgués María Izquierdo de Miguel Ana Julia González Huerta Marta Polo Zarzuela Blanca Boluda Karem Humala Maria Luisa Calabuig Maria Luz Amigo Marián Cuesta Casas María del Mar García-Saiz Ana Fernández Verdugo Javier Fernández Domínguez Teresa Bernal FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safety Trials Hematological neoplasms Febrile neutropenia Prophylaxis Gram-negative resistant bacteria Randomized controlled trial |
| title | FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safety |
| title_full | FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safety |
| title_fullStr | FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safety |
| title_full_unstemmed | FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safety |
| title_short | FOVOCIP study: a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients—efficacy and microbiologic safety |
| title_sort | fovocip study a multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients efficacy and microbiologic safety |
| topic | Hematological neoplasms Febrile neutropenia Prophylaxis Gram-negative resistant bacteria Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-023-07702-5 |
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