Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial
The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb ) is associated with a high rate of failure, up to 45% of cases. In addition, Sb can only administered parenterally and has important toxic effect. An effective, safe, and oral tre...
Saved in:
| Published in: | Clinical infectious diseases Vol. 64; no. 1; p. 67 |
|---|---|
| Main Authors: | , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
01.01.2017
|
| Subjects: | |
| ISSN: | 1537-6591, 1537-6591 |
| Online Access: | Get more information |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Abstract | The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb
) is associated with a high rate of failure, up to 45% of cases. In addition, Sb
can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required.
A randomized controlled clinical trial was conducted to compare the efficacy and safety of high-dosage oral fluconazole (6.5-8.0 mg/kg/d for 28 days) versus a standard Sb
protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil.
A total of 53 subjects were included in the trial; 26 were treated with Sb
, and 27 with fluconazole. Intention-to-treat analysis showed initial cure rates (2 months after treatment) of 22.2% (6 of 27) in the fluconazole and 53.8% (14 of 26) in the Sb
group (P = .04). Six months after treatment, the final cure rate remained the same in both groups, without any relapses. The frequencies of adverse effects in the Sb
and fluconazole groups were similar, 34.6% versus 37% respectively. One patient treated with fluconazole discontinued treatment owing to malaise, headache, and moderate dizziness (Common Terminology Criteria for Adverse Events grade 2).
Oral fluconazole at a dosage of 6.5-8 mg/kg/d for 28 days should not be considered an effective treatment for CL caused by L. braziliensisClinical Trials Registration. NCT01953744. |
|---|---|
| AbstractList | The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sbv) is associated with a high rate of failure, up to 45% of cases. In addition, Sbv can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required.BACKGROUND The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sbv) is associated with a high rate of failure, up to 45% of cases. In addition, Sbv can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required. A randomized controlled clinical trial was conducted to compare the efficacy and safety of high-dosage oral fluconazole (6.5-8.0 mg/kg/d for 28 days) versus a standard Sbv protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil.METHODS A randomized controlled clinical trial was conducted to compare the efficacy and safety of high-dosage oral fluconazole (6.5-8.0 mg/kg/d for 28 days) versus a standard Sbv protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil. A total of 53 subjects were included in the trial; 26 were treated with Sbv, and 27 with fluconazole. Intention-to-treat analysis showed initial cure rates (2 months after treatment) of 22.2% (6 of 27) in the fluconazole and 53.8% (14 of 26) in the Sbv group (P = .04). Six months after treatment, the final cure rate remained the same in both groups, without any relapses. The frequencies of adverse effects in the Sbv and fluconazole groups were similar, 34.6% versus 37% respectively. One patient treated with fluconazole discontinued treatment owing to malaise, headache, and moderate dizziness (Common Terminology Criteria for Adverse Events grade 2).RESULTS A total of 53 subjects were included in the trial; 26 were treated with Sbv, and 27 with fluconazole. Intention-to-treat analysis showed initial cure rates (2 months after treatment) of 22.2% (6 of 27) in the fluconazole and 53.8% (14 of 26) in the Sbv group (P = .04). Six months after treatment, the final cure rate remained the same in both groups, without any relapses. The frequencies of adverse effects in the Sbv and fluconazole groups were similar, 34.6% versus 37% respectively. One patient treated with fluconazole discontinued treatment owing to malaise, headache, and moderate dizziness (Common Terminology Criteria for Adverse Events grade 2). Oral fluconazole at a dosage of 6.5-8 mg/kg/d for 28 days should not be considered an effective treatment for CL caused by L. braziliensisClinical Trials Registration. NCT01953744.CONCLUSIONS Oral fluconazole at a dosage of 6.5-8 mg/kg/d for 28 days should not be considered an effective treatment for CL caused by L. braziliensisClinical Trials Registration. NCT01953744. The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb ) is associated with a high rate of failure, up to 45% of cases. In addition, Sb can only administered parenterally and has important toxic effect. An effective, safe, and oral treatment for CL is required. A randomized controlled clinical trial was conducted to compare the efficacy and safety of high-dosage oral fluconazole (6.5-8.0 mg/kg/d for 28 days) versus a standard Sb protocol (20 mg/kg/d for 20 days) for the treatment of CL in Bahia, Brazil. A total of 53 subjects were included in the trial; 26 were treated with Sb , and 27 with fluconazole. Intention-to-treat analysis showed initial cure rates (2 months after treatment) of 22.2% (6 of 27) in the fluconazole and 53.8% (14 of 26) in the Sb group (P = .04). Six months after treatment, the final cure rate remained the same in both groups, without any relapses. The frequencies of adverse effects in the Sb and fluconazole groups were similar, 34.6% versus 37% respectively. One patient treated with fluconazole discontinued treatment owing to malaise, headache, and moderate dizziness (Common Terminology Criteria for Adverse Events grade 2). Oral fluconazole at a dosage of 6.5-8 mg/kg/d for 28 days should not be considered an effective treatment for CL caused by L. braziliensisClinical Trials Registration. NCT01953744. |
| Author | Brito, Maria das Graças O Guimarães, Luiz H Almeida, Juliana Machado, Paulo R L Carvalho, Edgar M Silva, Silvana C Dourado, Mayra E F Schriefer, Albert Prates, Fernanda V de O |
| Author_xml | – sequence: 1 givenname: Fernanda V de O surname: Prates fullname: Prates, Fernanda V de O organization: Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia – sequence: 2 givenname: Mayra E F surname: Dourado fullname: Dourado, Mayra E F organization: Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia – sequence: 3 givenname: Silvana C surname: Silva fullname: Silva, Silvana C organization: Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia – sequence: 4 givenname: Albert surname: Schriefer fullname: Schriefer, Albert organization: Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais – sequence: 5 givenname: Luiz H surname: Guimarães fullname: Guimarães, Luiz H organization: Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais – sequence: 6 givenname: Maria das Graças O surname: Brito fullname: Brito, Maria das Graças O organization: Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia – sequence: 7 givenname: Juliana surname: Almeida fullname: Almeida, Juliana organization: Serviço de Imunologia, Hospital Universitário Prof Edgard Santos, Universidade Federal da Bahia – sequence: 8 givenname: Edgar M surname: Carvalho fullname: Carvalho, Edgar M organization: Centro de Pesquisa Gonçalo Moniz, Fiocruz, Salvador, Bahia, Brazil – sequence: 9 givenname: Paulo R L surname: Machado fullname: Machado, Paulo R L organization: Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27803094$$D View this record in MEDLINE/PubMed |
| BookMark | eNpNkE1LAzEQhoNU7Ide_AGSo5dqPjZp1ltZrAoFQep5SbKzNJJN6mYXbX-9C63Qw_A-vDwMzEzRKMQACN1S8kBJzh-tq4b5kZJdoAkVfDGXIqejMx6jaUpfhFCqiLhCY7ZQhJM8m6Dfle9tDPoQPWAXcLcFvGlBdw2EDscaF32nA8Q-4TW4tG10cDq5hAvdJ6iw2Z_12LT64LyDMBhPeIk_dKhi4w6DWMTQtdH7ATet0_4aXdbaJ7g55Qx9rp43xet8_f7yVizXc5sR2c11LiFntcpoJZUUQtVga25qyQgXtDLKVgwgE1wwMNwA40xlllMrlTWQEzZD98e9uzZ-95C6snHJgvfHq0qquBBckSwf1LuT2psGqnLXuka3-_L_W-wP7T9vew |
| CitedBy_id | crossref_primary_10_1111_ijd_15902 crossref_primary_10_1371_journal_pone_0186117 crossref_primary_10_1590_0037_8682_0292_2018 crossref_primary_10_1080_14656566_2019_1609940 crossref_primary_10_3389_fchem_2021_622286 crossref_primary_10_3389_fcimb_2022_1059168 crossref_primary_10_1016_j_ijid_2020_11_183 crossref_primary_10_1016_j_ejmech_2019_02_070 crossref_primary_10_1111_dth_15060 crossref_primary_10_12688_f1000research_11120_1 crossref_primary_10_3201_eid3003_230786 crossref_primary_10_1093_cid_ciaa1337 crossref_primary_10_52711_0974_360X_2021_00857 crossref_primary_10_1016_j_exppara_2024_108743 crossref_primary_10_1371_journal_pntd_0006225 crossref_primary_10_1016_j_actatropica_2021_106192 crossref_primary_10_1016_j_idc_2018_10_004 crossref_primary_10_1371_journal_pntd_0009321 crossref_primary_10_1093_cid_ciab236 crossref_primary_10_1128_msphere_00814_23 crossref_primary_10_2478_s11686_020_00205_2 crossref_primary_10_1111_pde_13493 crossref_primary_10_64095_ajst_v3i1_60 crossref_primary_10_1371_journal_pone_0298458 crossref_primary_10_1007_s40257_022_00726_8 crossref_primary_10_13005_bpj_3193 crossref_primary_10_1371_journal_pntd_0011064 crossref_primary_10_1093_ofid_ofad387 crossref_primary_10_7759_cureus_84618 crossref_primary_10_1007_s40121_022_00602_2 crossref_primary_10_1016_j_actatropica_2021_105944 crossref_primary_10_1016_j_actatropica_2021_105988 crossref_primary_10_1155_2020_2789859 crossref_primary_10_1186_s12879_019_4237_3 crossref_primary_10_4155_fmc_2019_0201 crossref_primary_10_1590_0074_02760190361 crossref_primary_10_3389_fimmu_2022_974051 crossref_primary_10_1016_j_ijid_2021_02_016 crossref_primary_10_1080_17425255_2019_1629417 crossref_primary_10_3389_fimmu_2018_02621 crossref_primary_10_3390_pathogens13050416 crossref_primary_10_1186_s12879_024_09211_5 crossref_primary_10_1007_s00253_020_10856_w crossref_primary_10_3390_tropicalmed10050142 crossref_primary_10_1590_0074_02760170217 |
| ContentType | Journal Article |
| Copyright | The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com. |
| Copyright_xml | – notice: The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com. |
| DBID | CGR CUY CVF ECM EIF NPM 7X8 |
| DOI | 10.1093/cid/ciw662 |
| DatabaseName | Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed MEDLINE - Academic |
| DatabaseTitle | MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) MEDLINE - Academic |
| DatabaseTitleList | MEDLINE - Academic MEDLINE |
| Database_xml | – sequence: 1 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 2 dbid: 7X8 name: MEDLINE - Academic url: https://search.proquest.com/medline sourceTypes: Aggregation Database |
| DeliveryMethod | no_fulltext_linktorsrc |
| Discipline | Medicine |
| EISSN | 1537-6591 |
| ExternalDocumentID | 27803094 |
| Genre | Randomized Controlled Trial Journal Article |
| GroupedDBID | --- ..I .2P .I3 .ZR 08P 0R~ 1KJ 1TH 29B 2AX 2WC 36B 4.4 48X 53G 5GY 5RE 5VS 5WD 6J9 70D AABZA AACGO AACZT AAJKP AAJQQ AAMVS AANCE AAOGV AAPNW AAPQZ AAPXW AAQQT AARHZ AAUAY AAUQX AAVAP ABBHK ABDFA ABEJV ABEUO ABGNP ABIXL ABJNI ABKDP ABLJU ABNHQ ABNKS ABOCM ABPLY ABPQP ABPTD ABQLI ABQNK ABTLG ABVGC ABWST ABXSQ ABXVV ABZBJ ACGFO ACGFS ACHIC ACPRK ACUFI ACUTJ ACUTO ACYHN ADBBV ADEYI ADGZP ADHKW ADHZD ADIPN ADNBA ADOCK ADQBN ADQXQ ADRTK ADVEK ADYVW ADZXQ AEGPL AEGXH AEJOX AEKSI AEMDU AEMQT AENEX AENZO AEPUE AETBJ AEUPB AEWNT AEXZC AFFZL AFIYH AFOFC AFRAH AFXAL AFYAG AGINJ AGKEF AGORE AGQXC AGSYK AGUTN AHMBA AHMMS AHXPO AIAGR AIJHB AJBYB AJEEA AJNCP ALMA_UNASSIGNED_HOLDINGS ALUQC ALXQX APIBT APWMN AQKUS AQVQM ATGXG AXUDD BAWUL BAYMD BCRHZ BEYMZ BHONS BTRTY BVRKM C45 CDBKE CGR CS3 CUY CVF CZ4 DAKXR DCCCD DIK DILTD DU5 D~K E3Z EBS ECM EE~ EIF EJD EMOBN ENERS F5P F9B FECEO FLUFQ FOEOM FOTVD FQBLK GAUVT GJXCC H13 H5~ HAR HW0 HZ~ IOX IPSME J21 JAAYA JBMMH JENOY JHFFW JKQEH JLS JLXEF JPM JSG JST JXSIZ KAQDR KBUDW KOP KSI KSN L7B MHKGH MJL ML0 N9A NGC NOMLY NOYVH NPM NU- NVLIB O9- OAUYM OAWHX OCZFY ODMLO ODZKP OJQWA OJZSN OK1 OPAEJ OVD OWPYF P2P P6G PAFKI PEELM PQQKQ Q1. Q5Y QBD RD5 ROX ROZ RUSNO RW1 RXO SA0 SJN TCURE TEORI TJX TMA TR2 W8F X7H YAYTL YKOAZ YXANX ~91 ~S- 7X8 |
| ID | FETCH-LOGICAL-c406t-a96e92f841d686558fecf3bf620351db8cd2ee45352eb3be23284c31c68cbe902 |
| IEDL.DBID | 7X8 |
| ISICitedReferencesCount | 49 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=000397123100019&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 1537-6591 |
| IngestDate | Sun Sep 28 06:30:40 EDT 2025 Mon Jul 21 05:51:10 EDT 2025 |
| IsDoiOpenAccess | false |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 1 |
| Keywords | fluconazole cutaneous leishmaniasis pentavalent antimony Leishmania (V.) braziliensis |
| Language | English |
| License | The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com. |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-c406t-a96e92f841d686558fecf3bf620351db8cd2ee45352eb3be23284c31c68cbe902 |
| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Undefined-3 |
| OpenAccessLink | https://academic.oup.com/cid/article-pdf/64/1/67/8485302/ciw662.pdf |
| PMID | 27803094 |
| PQID | 1835538049 |
| PQPubID | 23479 |
| ParticipantIDs | proquest_miscellaneous_1835538049 pubmed_primary_27803094 |
| PublicationCentury | 2000 |
| PublicationDate | 2017-Jan-01 20170101 |
| PublicationDateYYYYMMDD | 2017-01-01 |
| PublicationDate_xml | – month: 01 year: 2017 text: 2017-Jan-01 day: 01 |
| PublicationDecade | 2010 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Clinical infectious diseases |
| PublicationTitleAlternate | Clin Infect Dis |
| PublicationYear | 2017 |
| SSID | ssj0011805 |
| Score | 2.4421108 |
| Snippet | The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sb
) is associated with a high rate of... The treatment of cutaneous leishmaniasis (CL) caused by Leishmania braziliensis in Brazil with pentavalent antimony (Sbv) is associated with a high rate of... |
| SourceID | proquest pubmed |
| SourceType | Aggregation Database Index Database |
| StartPage | 67 |
| SubjectTerms | Adolescent Adult Antimony - administration & dosage Antimony - adverse effects Antimony - therapeutic use Antiprotozoal Agents - administration & dosage Antiprotozoal Agents - adverse effects Antiprotozoal Agents - therapeutic use Brazil Female Fluconazole - administration & dosage Fluconazole - adverse effects Fluconazole - therapeutic use Humans Leishmania braziliensis - drug effects Leishmania braziliensis - genetics Leishmaniasis, Cutaneous - diagnosis Leishmaniasis, Cutaneous - drug therapy Leishmaniasis, Cutaneous - parasitology Male Middle Aged Treatment Outcome Young Adult |
| Title | Fluconazole in the Treatment of Cutaneous Leishmaniasis Caused by Leishmania braziliensis: A Randomized Controlled Trial |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/27803094 https://www.proquest.com/docview/1835538049 |
| Volume | 64 |
| WOSCitedRecordID | wos000397123100019&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV1LS8NAEF58IV58vx-s4DXUbJ7rRSRYPNhSpEJvZXczi4GaVGN99Nc7k6TUiyB4CSFsINn5ZufbmdkZxi4UmgDcBQTU0MQ4vlWRo6WOHa2otoi0vhGqajYRdbvxYCB7jcOtbNIqZ2titVCnhSEfeQuhF6ByIqG9Hr841DWKoqtNC41FtuwhlSFUR4N5FMGNqxRGVOrICQPpzsqTSq9lUNQm-wipS85v1LIyMe2N_37cJltvyCW_qdGwxRYg32arnSZ8vsM-25SgnqtpMQKe5RzJH-_PMs15YXkyQa4IxaTk95CVT1QbQ5VZyRM1KSHl-uvHc4777GmGFDbHEVf8hj-oPC2esykOTOoE-BHe9gnhu-yxfdtP7pym9YJj0MK_OUqGIIWNfTcN6ehqbMFYT9tQUOQx1bFJBYBPtWFwN64BeVnsG881KHEN8lLssaW8yOGAcTBgtIDAA0_7fgDSisBTrqZabzZI4ZCdz-Z0iNCmeEX9p8P5rB6y_Voww3Fdg2MoopiCQ_7RH94-ZmuCjHHlODlhyxYVG07Zinl_y8rXswozeO32Ot93Ns7_ |
| linkProvider | ProQuest |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Fluconazole+in+the+Treatment+of+Cutaneous+Leishmaniasis+Caused+by+Leishmania+braziliensis%3A+A+Randomized+Controlled+Trial&rft.jtitle=Clinical+infectious+diseases&rft.au=Prates%2C+Fernanda+V+de+O&rft.au=Dourado%2C+Mayra+E+F&rft.au=Silva%2C+Silvana+C&rft.au=Schriefer%2C+Albert&rft.date=2017-01-01&rft.eissn=1537-6591&rft.volume=64&rft.issue=1&rft.spage=67&rft_id=info:doi/10.1093%2Fcid%2Fciw662&rft_id=info%3Apmid%2F27803094&rft_id=info%3Apmid%2F27803094&rft.externalDocID=27803094 |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1537-6591&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1537-6591&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1537-6591&client=summon |