Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: Results of a prospective, double-blind, randomized, placebo-controlled trial.
Identifieur interne : 000598 ( Main/Exploration ); précédent : 000597; suivant : 000599Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: Results of a prospective, double-blind, randomized, placebo-controlled trial.
Auteurs : Samir J. Patel [États-Unis] ; Richard J. Knight [États-Unis] ; Samantha A. Kuten [États-Unis] ; Edward A. Graviss [États-Unis] ; Duc T. Nguyen [États-Unis] ; Linda W. Moore [États-Unis] ; William L. Musick [États-Unis] ; Ahmed Osama Gaber [États-Unis]Source :
- American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons [ 1600-6143 ] ; 2019.
Descripteurs français
- KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Ciprofloxacine (usage thérapeutique), Défaillance rénale chronique (chirurgie), Défaillance rénale chronique (complications), Femelle (MeSH), Fluoroquinolones (usage thérapeutique), Humains (MeSH), Immunosuppresseurs (usage thérapeutique), Infections opportunistes (prévention et contrôle), Infections à polyomavirus (prévention et contrôle), Infections à virus oncogènes (prévention et contrôle), Mâle (MeSH), Méthode en double aveugle (MeSH), Résultat thérapeutique (MeSH), Transplantation rénale (effets indésirables), Virus BK (MeSH), Virémie (prévention et contrôle), Études prospectives (MeSH).
- MESH :
- chirurgie : Défaillance rénale chronique.
- effets indésirables : Défaillance rénale chronique, Transplantation rénale.
- prévention et contrôle : Infections opportunistes, Infections à polyomavirus, Infections à virus oncogènes, Virémie.
- usage thérapeutique : Ciprofloxacine, Fluoroquinolones, Immunosuppresseurs.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Mâle, Méthode en double aveugle, Résultat thérapeutique, Virus BK, Études prospectives.
English descriptors
- KwdEn :
- Adult (MeSH), BK Virus (MeSH), Ciprofloxacin (therapeutic use), Double-Blind Method (MeSH), Female (MeSH), Fluoroquinolones (therapeutic use), Humans (MeSH), Immunosuppressive Agents (therapeutic use), Kidney Failure, Chronic (complications), Kidney Failure, Chronic (surgery), Kidney Transplantation (adverse effects), Male (MeSH), Middle Aged (MeSH), Opportunistic Infections (prevention & control), Polyomavirus Infections (prevention & control), Prospective Studies (MeSH), Treatment Outcome (MeSH), Tumor Virus Infections (prevention & control), Viremia (prevention & control).
- MESH :
- chemical , therapeutic use : Ciprofloxacin, Fluoroquinolones, Immunosuppressive Agents.
- adverse effects : Kidney Transplantation.
- complications : Kidney Failure, Chronic.
- prevention & control : Opportunistic Infections, Polyomavirus Infections, Tumor Virus Infections, Viremia.
- surgery : Kidney Failure, Chronic.
- Adult, BK Virus, Double-Blind Method, Female, Humans, Male, Middle Aged, Prospective Studies, Treatment Outcome.
Abstract
In kidney transplantation, BK virus infection has historically resulted in high rates of graft dysfunction and graft loss. Unlike other opportunistic infections, no therapies have been shown to prevent BK. The purpose of the current study was to evaluate the safety and efficacy of ciprofloxacin for the prevention of BK viremia in kidney transplant recipients. Two hundred kidney transplant recipients were enrolled in a prospective, randomized, double-blind, placebo-controlled trial comparing a 3-month course of ciprofloxacin (n = 133) vs placebo (n = 67) for the prevention of BK viremia. The primary endpoint of BK viremia at month 6 posttransplant occurred in 25 (18.8%) patients in the ciprofloxacin group and 5 (7.5%) in the placebo group (P = .03). Higher rates of BK viremia (23.3% vs 11.9%; P = .06) and BK nephropathy (5.8% vs 1.5%; P = .26) remained at 12 months in the ciprofloxacin group. Ciprofloxacin use was associated with a significantly higher rate of fluoroquinolone-resistant gram-negative infections (83.3% vs 50%; P = .04). A 3-month course of ciprofloxacin was ineffective at preventing BK viremia in kidney transplant recipients and was associated with an increased risk of fluoroquinolone-resistant infections. Clinical trial registration number: NCT01789203.
DOI: 10.1111/ajt.15328
PubMed: 30811872
Affiliations:
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Society of Transplant Surgeons</title><idno type="eISSN">1600-6143</idno><imprint><date when="2019" type="published">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>BK Virus (MeSH)</term><term>Ciprofloxacin (therapeutic use)</term><term>Double-Blind Method (MeSH)</term><term>Female (MeSH)</term><term>Fluoroquinolones (therapeutic use)</term><term>Humans (MeSH)</term><term>Immunosuppressive Agents (therapeutic use)</term><term>Kidney Failure, Chronic (complications)</term><term>Kidney Failure, Chronic (surgery)</term><term>Kidney Transplantation (adverse effects)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Opportunistic Infections (prevention & control)</term><term>Polyomavirus Infections (prevention & control)</term><term>Prospective Studies (MeSH)</term><term>Treatment Outcome (MeSH)</term><term>Tumor Virus Infections (prevention & control)</term><term>Viremia (prevention & control)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Ciprofloxacine (usage thérapeutique)</term><term>Défaillance rénale chronique (chirurgie)</term><term>Défaillance rénale chronique (complications)</term><term>Femelle (MeSH)</term><term>Fluoroquinolones (usage thérapeutique)</term><term>Humains (MeSH)</term><term>Immunosuppresseurs (usage thérapeutique)</term><term>Infections opportunistes (prévention et contrôle)</term><term>Infections à polyomavirus (prévention et contrôle)</term><term>Infections à virus oncogènes (prévention et contrôle)</term><term>Mâle (MeSH)</term><term>Méthode en double aveugle (MeSH)</term><term>Résultat thérapeutique (MeSH)</term><term>Transplantation rénale (effets indésirables)</term><term>Virus BK (MeSH)</term><term>Virémie (prévention et contrôle)</term><term>Études prospectives (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Ciprofloxacin</term><term>Fluoroquinolones</term><term>Immunosuppressive Agents</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Kidney Transplantation</term></keywords><keywords scheme="MESH" qualifier="chirurgie" xml:lang="fr"><term>Défaillance rénale chronique</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Kidney Failure, Chronic</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Défaillance rénale chronique</term><term>Transplantation rénale</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Opportunistic Infections</term><term>Polyomavirus Infections</term><term>Tumor Virus Infections</term><term>Viremia</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Infections opportunistes</term><term>Infections à polyomavirus</term><term>Infections à virus oncogènes</term><term>Virémie</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Kidney Failure, Chronic</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Ciprofloxacine</term><term>Fluoroquinolones</term><term>Immunosuppresseurs</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>BK Virus</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Prospective Studies</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Virus BK</term><term>Études prospectives</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In kidney transplantation, BK virus infection has historically resulted in high rates of graft dysfunction and graft loss. Unlike other opportunistic infections, no therapies have been shown to prevent BK. The purpose of the current study was to evaluate the safety and efficacy of ciprofloxacin for the prevention of BK viremia in kidney transplant recipients. Two hundred kidney transplant recipients were enrolled in a prospective, randomized, double-blind, placebo-controlled trial comparing a 3-month course of ciprofloxacin (n = 133) vs placebo (n = 67) for the prevention of BK viremia. The primary endpoint of BK viremia at month 6 posttransplant occurred in 25 (18.8%) patients in the ciprofloxacin group and 5 (7.5%) in the placebo group (P = .03). Higher rates of BK viremia (23.3% vs 11.9%; P = .06) and BK nephropathy (5.8% vs 1.5%; P = .26) remained at 12 months in the ciprofloxacin group. Ciprofloxacin use was associated with a significantly higher rate of fluoroquinolone-resistant gram-negative infections (83.3% vs 50%; P = .04). A 3-month course of ciprofloxacin was ineffective at preventing BK viremia in kidney transplant recipients and was associated with an increased risk of fluoroquinolone-resistant infections. Clinical trial registration number: NCT01789203.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30811872</PMID><DateCompleted><Year>2020</Year><Month>08</Month><Day>12</Day></DateCompleted><DateRevised><Year>2020</Year><Month>08</Month><Day>12</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1600-6143</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>6</Issue><PubDate><Year>2019</Year><Month>06</Month></PubDate></JournalIssue><Title>American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons</Title><ISOAbbreviation>Am J Transplant</ISOAbbreviation></Journal><ArticleTitle>Ciprofloxacin for BK viremia prophylaxis in kidney transplant recipients: Results of a prospective, double-blind, randomized, placebo-controlled trial.</ArticleTitle><Pagination><MedlinePgn>1831-1837</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1111/ajt.15328</ELocationID><Abstract><AbstractText>In kidney transplantation, BK virus infection has historically resulted in high rates of graft dysfunction and graft loss. Unlike other opportunistic infections, no therapies have been shown to prevent BK. The purpose of the current study was to evaluate the safety and efficacy of ciprofloxacin for the prevention of BK viremia in kidney transplant recipients. Two hundred kidney transplant recipients were enrolled in a prospective, randomized, double-blind, placebo-controlled trial comparing a 3-month course of ciprofloxacin (n = 133) vs placebo (n = 67) for the prevention of BK viremia. The primary endpoint of BK viremia at month 6 posttransplant occurred in 25 (18.8%) patients in the ciprofloxacin group and 5 (7.5%) in the placebo group (P = .03). Higher rates of BK viremia (23.3% vs 11.9%; P = .06) and BK nephropathy (5.8% vs 1.5%; P = .26) remained at 12 months in the ciprofloxacin group. Ciprofloxacin use was associated with a significantly higher rate of fluoroquinolone-resistant gram-negative infections (83.3% vs 50%; P = .04). A 3-month course of ciprofloxacin was ineffective at preventing BK viremia in kidney transplant recipients and was associated with an increased risk of fluoroquinolone-resistant infections. Clinical trial registration number: NCT01789203.</AbstractText><CopyrightInformation>© 2019 The American Society of Transplantation and the American Society of Transplant Surgeons.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Patel</LastName><ForeName>Samir J</ForeName><Initials>SJ</Initials><Identifier Source="ORCID">0000-0001-9946-2798</Identifier><AffiliationInfo><Affiliation>Department of Pharmacy, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Knight</LastName><ForeName>Richard J</ForeName><Initials>RJ</Initials><Identifier Source="ORCID">0000-0002-0870-629X</Identifier><AffiliationInfo><Affiliation>Department of Surgery, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kuten</LastName><ForeName>Samantha A</ForeName><Initials>SA</Initials><Identifier Source="ORCID">0000-0002-8994-0968</Identifier><AffiliationInfo><Affiliation>Department of Pharmacy, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Graviss</LastName><ForeName>Edward A</ForeName><Initials>EA</Initials><Identifier Source="ORCID">0000-0003-1024-5813</Identifier><AffiliationInfo><Affiliation>Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nguyen</LastName><ForeName>Duc T</ForeName><Initials>DT</Initials><Identifier Source="ORCID">0000-0002-5059-4404</Identifier><AffiliationInfo><Affiliation>Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moore</LastName><ForeName>Linda W</ForeName><Initials>LW</Initials><Identifier Source="ORCID">0000-0003-2519-5150</Identifier><AffiliationInfo><Affiliation>Department of Surgery, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Musick</LastName><ForeName>William L</ForeName><Initials>WL</Initials><Identifier Source="ORCID">0000-0002-5148-4290</Identifier><AffiliationInfo><Affiliation>Department of Pharmacy, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gaber</LastName><ForeName>Ahmed Osama</ForeName><Initials>AO</Initials><Identifier Source="ORCID">0000-0002-0743-4974</Identifier><AffiliationInfo><Affiliation>Department of Surgery, Houston Methodist Hospital, Houston, Texas.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01789203</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>04</Month><Day>04</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Am J Transplant</MedlineTA><NlmUniqueID>100968638</NlmUniqueID><ISSNLinking>1600-6135</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D024841">Fluoroquinolones</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007166">Immunosuppressive Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>5E8K9I0O4U</RegistryNumber><NameOfSubstance UI="D002939">Ciprofloxacin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D001739" MajorTopicYN="Y">BK Virus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002939" MajorTopicYN="N">Ciprofloxacin</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D024841" MajorTopicYN="N">Fluoroquinolones</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007166" MajorTopicYN="N">Immunosuppressive Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007676" MajorTopicYN="N">Kidney Failure, Chronic</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="Y">complications</QualifierName><QualifierName UI="Q000601" MajorTopicYN="Y">surgery</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016030" MajorTopicYN="Y">Kidney Transplantation</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009894" MajorTopicYN="N">Opportunistic Infections</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D027601" MajorTopicYN="N">Polyomavirus Infections</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014412" MajorTopicYN="N">Tumor Virus Infections</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014766" MajorTopicYN="N">Viremia</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">antibiotic prophylaxis</Keyword><Keyword MajorTopicYN="Y">antibiotic: antiviral</Keyword><Keyword MajorTopicYN="Y">clinical research/practice</Keyword><Keyword MajorTopicYN="Y">infection and infectious agents - viral: BK/JC/polyoma</Keyword><Keyword MajorTopicYN="Y">kidney transplantation/nephrology</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2018</Year><Month>09</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2019</Year><Month>01</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2019</Year><Month>02</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2019</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>8</Month><Day>13</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2019</Year><Month>2</Month><Day>28</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">30811872</ArticleId><ArticleId IdType="doi">10.1111/ajt.15328</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Texas</li></region></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Patel, Samir J" sort="Patel, Samir J" uniqKey="Patel S" first="Samir J" last="Patel">Samir J. Patel</name></region><name sortKey="Gaber, Ahmed Osama" sort="Gaber, Ahmed Osama" uniqKey="Gaber A" first="Ahmed Osama" last="Gaber">Ahmed Osama Gaber</name><name sortKey="Graviss, Edward A" sort="Graviss, Edward A" uniqKey="Graviss E" first="Edward A" last="Graviss">Edward A. Graviss</name><name sortKey="Knight, Richard J" sort="Knight, Richard J" uniqKey="Knight R" first="Richard J" last="Knight">Richard J. Knight</name><name sortKey="Kuten, Samantha A" sort="Kuten, Samantha A" uniqKey="Kuten S" first="Samantha A" last="Kuten">Samantha A. Kuten</name><name sortKey="Moore, Linda W" sort="Moore, Linda W" uniqKey="Moore L" first="Linda W" last="Moore">Linda W. Moore</name><name sortKey="Musick, William L" sort="Musick, William L" uniqKey="Musick W" first="William L" last="Musick">William L. Musick</name><name sortKey="Nguyen, Duc T" sort="Nguyen, Duc T" uniqKey="Nguyen D" first="Duc T" last="Nguyen">Duc T. 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