Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon
Treatment recommendations for and malaria are largely based on anecdotal evidence. The aim of this prospective study, conducted in Gabon, was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated or species monoinfections or mixe...
Gespeichert in:
Veröffentlicht in: | Antimicrobial agents and chemotherapy 2018-03, Vol.62 (3) |
---|---|
Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | |
---|---|
container_issue | 3 |
container_start_page | |
container_title | Antimicrobial agents and chemotherapy |
container_volume | 62 |
creator | Groger, Mirjam Veletzky, Luzia Lalremruata, Albert Cattaneo, Chiara Mischlinger, Johannes Zoleko-Manego, Rella Endamne, Lilian Klicpera, Anna Kim, Johanna Nguyen, The Flohr, Lena Remppis, Jonathan Matsiegui, Pierre-Blaise Adegnika, Ayôla A Agnandji, Selidji T Kremsner, Peter G Mordmüller, Benjamin Mombo-Ngoma, Ghyslain Ramharter, Michael |
description | Treatment recommendations for
and
malaria are largely based on anecdotal evidence. The aim of this prospective study, conducted in Gabon, was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated
or
species monoinfections or mixed
infections. Patients with microscopically confirmed
,
, or mixed-species malaria with at least one of these two
species were treated with an oral, fixed-dose combination of artemether-lumefantrine for 3 consecutive days. The primary endpoints were per-protocol PCR-corrected adequate clinical and parasitological response (ACPR) on days 28 and 42. Tolerability and safety were recorded throughout the follow-up period. Seventy-two participants (42 male and 30 female) were enrolled; 62.5% of them had PCR-corrected mixed
infections. Per protocol, PCR-corrected ACPR rates were 96.6% (95% confidence interval [CI], 91.9 to 100) on day 28 and 94.2% (95% CI, 87.7 to 100) on day 42. Considering
species independently from their coinfecting species, day 42 ACPR rates were 95.5% (95% CI, 89.0 to 100) for
, 100% (exact CI, 84.6 to 100) for
, 100% (exact CI, 76.8 to 100) for
, and 90.9% (95% CI, 70.7 to 100) for
Study drug-related adverse events were generally mild or moderate. In conclusion, this clinical trial demonstrated satisfying antimalarial activity of artemether-lumefantrine against
,
,
, and mixed
infections, with per-protocol efficacies of 90% to 100% and without evident tolerability or safety concerns. (This trial was registered in the clinical study database ClinicalTrials.gov under the identifier NCT02528279.). |
doi_str_mv | 10.1128/AAC.01758-17 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5826119</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1989551563</sourcerecordid><originalsourceid>FETCH-LOGICAL-a418t-25ac8a9761b81f0f5da4f4e594d047e50a597b5897c41278145a88d886769fe73</originalsourceid><addsrcrecordid>eNp1UsFO3DAQtapWZYHeeq58bCVC7Wzs2JdK0QpopUVFKpyt2WQMRom9tZNV-TZ-Di9L0fbQy4z85vmNZ54J-cjZKeel-to0i1PGa6EKXr8hM860KqTQ8i2ZMSZlUSlWHZDDlO5ZPgvN3pODUs85Z0rOyONVDGmN7eg2SBe9866Fnl5Hl2OTEqbk_C39lRkOU_GcrWvpmc0R2gcaLG3iiAOOdxiL5TSgBT9G55HaEGlGsxjCOKAft-SrHtIQOjcNdIAech882QfDBvqMgO_opfuD3X7tcneBOk8vYBX8MXlnoU_44SUfkZvzs-vF92L58-LHolkWUHE1FqWAVoGuJV8pbpkVHVS2QqGrjlU1CgZC1yuhdN1WvKwVrwQo1Skla6kt1vMj8m2nu55WA3ZtHiVCb9bRDRAfTABn_q14d2duw8YIVUrOdRb4_CIQw-8J02gGl1rse_AYpmS4VloILuQ8U0921Db7kiLa1zacma3fJvttnv02fPu0Lzt6XlJp7sMUfd7E_7if9sd4Ff77GeZPiEK2UQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1989551563</pqid></control><display><type>article</type><title>Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon</title><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Groger, Mirjam ; Veletzky, Luzia ; Lalremruata, Albert ; Cattaneo, Chiara ; Mischlinger, Johannes ; Zoleko-Manego, Rella ; Endamne, Lilian ; Klicpera, Anna ; Kim, Johanna ; Nguyen, The ; Flohr, Lena ; Remppis, Jonathan ; Matsiegui, Pierre-Blaise ; Adegnika, Ayôla A ; Agnandji, Selidji T ; Kremsner, Peter G ; Mordmüller, Benjamin ; Mombo-Ngoma, Ghyslain ; Ramharter, Michael</creator><creatorcontrib>Groger, Mirjam ; Veletzky, Luzia ; Lalremruata, Albert ; Cattaneo, Chiara ; Mischlinger, Johannes ; Zoleko-Manego, Rella ; Endamne, Lilian ; Klicpera, Anna ; Kim, Johanna ; Nguyen, The ; Flohr, Lena ; Remppis, Jonathan ; Matsiegui, Pierre-Blaise ; Adegnika, Ayôla A ; Agnandji, Selidji T ; Kremsner, Peter G ; Mordmüller, Benjamin ; Mombo-Ngoma, Ghyslain ; Ramharter, Michael</creatorcontrib><description>Treatment recommendations for
and
malaria are largely based on anecdotal evidence. The aim of this prospective study, conducted in Gabon, was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated
or
species monoinfections or mixed
infections. Patients with microscopically confirmed
,
, or mixed-species malaria with at least one of these two
species were treated with an oral, fixed-dose combination of artemether-lumefantrine for 3 consecutive days. The primary endpoints were per-protocol PCR-corrected adequate clinical and parasitological response (ACPR) on days 28 and 42. Tolerability and safety were recorded throughout the follow-up period. Seventy-two participants (42 male and 30 female) were enrolled; 62.5% of them had PCR-corrected mixed
infections. Per protocol, PCR-corrected ACPR rates were 96.6% (95% confidence interval [CI], 91.9 to 100) on day 28 and 94.2% (95% CI, 87.7 to 100) on day 42. Considering
species independently from their coinfecting species, day 42 ACPR rates were 95.5% (95% CI, 89.0 to 100) for
, 100% (exact CI, 84.6 to 100) for
, 100% (exact CI, 76.8 to 100) for
, and 90.9% (95% CI, 70.7 to 100) for
Study drug-related adverse events were generally mild or moderate. In conclusion, this clinical trial demonstrated satisfying antimalarial activity of artemether-lumefantrine against
,
,
, and mixed
infections, with per-protocol efficacies of 90% to 100% and without evident tolerability or safety concerns. (This trial was registered in the clinical study database ClinicalTrials.gov under the identifier NCT02528279.).</description><identifier>ISSN: 0066-4804</identifier><identifier>EISSN: 1098-6596</identifier><identifier>DOI: 10.1128/AAC.01758-17</identifier><identifier>PMID: 29311086</identifier><language>eng</language><publisher>United States: American Society for Microbiology</publisher><subject>Antimalarials ; Artemether ; Clinical Therapeutics ; Lumefantrine ; Plasmodium malariae ; Plasmodium ovale</subject><ispartof>Antimicrobial agents and chemotherapy, 2018-03, Vol.62 (3)</ispartof><rights>Copyright © 2018 American Society for Microbiology.</rights><rights>Copyright © 2018 American Society for Microbiology. 2018 American Society for Microbiology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a418t-25ac8a9761b81f0f5da4f4e594d047e50a597b5897c41278145a88d886769fe73</citedby><cites>FETCH-LOGICAL-a418t-25ac8a9761b81f0f5da4f4e594d047e50a597b5897c41278145a88d886769fe73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5826119/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5826119/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29311086$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Groger, Mirjam</creatorcontrib><creatorcontrib>Veletzky, Luzia</creatorcontrib><creatorcontrib>Lalremruata, Albert</creatorcontrib><creatorcontrib>Cattaneo, Chiara</creatorcontrib><creatorcontrib>Mischlinger, Johannes</creatorcontrib><creatorcontrib>Zoleko-Manego, Rella</creatorcontrib><creatorcontrib>Endamne, Lilian</creatorcontrib><creatorcontrib>Klicpera, Anna</creatorcontrib><creatorcontrib>Kim, Johanna</creatorcontrib><creatorcontrib>Nguyen, The</creatorcontrib><creatorcontrib>Flohr, Lena</creatorcontrib><creatorcontrib>Remppis, Jonathan</creatorcontrib><creatorcontrib>Matsiegui, Pierre-Blaise</creatorcontrib><creatorcontrib>Adegnika, Ayôla A</creatorcontrib><creatorcontrib>Agnandji, Selidji T</creatorcontrib><creatorcontrib>Kremsner, Peter G</creatorcontrib><creatorcontrib>Mordmüller, Benjamin</creatorcontrib><creatorcontrib>Mombo-Ngoma, Ghyslain</creatorcontrib><creatorcontrib>Ramharter, Michael</creatorcontrib><title>Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon</title><title>Antimicrobial agents and chemotherapy</title><addtitle>Antimicrob Agents Chemother</addtitle><addtitle>Antimicrob Agents Chemother</addtitle><description>Treatment recommendations for
and
malaria are largely based on anecdotal evidence. The aim of this prospective study, conducted in Gabon, was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated
or
species monoinfections or mixed
infections. Patients with microscopically confirmed
,
, or mixed-species malaria with at least one of these two
species were treated with an oral, fixed-dose combination of artemether-lumefantrine for 3 consecutive days. The primary endpoints were per-protocol PCR-corrected adequate clinical and parasitological response (ACPR) on days 28 and 42. Tolerability and safety were recorded throughout the follow-up period. Seventy-two participants (42 male and 30 female) were enrolled; 62.5% of them had PCR-corrected mixed
infections. Per protocol, PCR-corrected ACPR rates were 96.6% (95% confidence interval [CI], 91.9 to 100) on day 28 and 94.2% (95% CI, 87.7 to 100) on day 42. Considering
species independently from their coinfecting species, day 42 ACPR rates were 95.5% (95% CI, 89.0 to 100) for
, 100% (exact CI, 84.6 to 100) for
, 100% (exact CI, 76.8 to 100) for
, and 90.9% (95% CI, 70.7 to 100) for
Study drug-related adverse events were generally mild or moderate. In conclusion, this clinical trial demonstrated satisfying antimalarial activity of artemether-lumefantrine against
,
,
, and mixed
infections, with per-protocol efficacies of 90% to 100% and without evident tolerability or safety concerns. (This trial was registered in the clinical study database ClinicalTrials.gov under the identifier NCT02528279.).</description><subject>Antimalarials</subject><subject>Artemether</subject><subject>Clinical Therapeutics</subject><subject>Lumefantrine</subject><subject>Plasmodium malariae</subject><subject>Plasmodium ovale</subject><issn>0066-4804</issn><issn>1098-6596</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNp1UsFO3DAQtapWZYHeeq58bCVC7Wzs2JdK0QpopUVFKpyt2WQMRom9tZNV-TZ-Di9L0fbQy4z85vmNZ54J-cjZKeel-to0i1PGa6EKXr8hM860KqTQ8i2ZMSZlUSlWHZDDlO5ZPgvN3pODUs85Z0rOyONVDGmN7eg2SBe9866Fnl5Hl2OTEqbk_C39lRkOU_GcrWvpmc0R2gcaLG3iiAOOdxiL5TSgBT9G55HaEGlGsxjCOKAft-SrHtIQOjcNdIAech882QfDBvqMgO_opfuD3X7tcneBOk8vYBX8MXlnoU_44SUfkZvzs-vF92L58-LHolkWUHE1FqWAVoGuJV8pbpkVHVS2QqGrjlU1CgZC1yuhdN1WvKwVrwQo1Skla6kt1vMj8m2nu55WA3ZtHiVCb9bRDRAfTABn_q14d2duw8YIVUrOdRb4_CIQw-8J02gGl1rse_AYpmS4VloILuQ8U0921Db7kiLa1zacma3fJvttnv02fPu0Lzt6XlJp7sMUfd7E_7if9sd4Ff77GeZPiEK2UQ</recordid><startdate>20180301</startdate><enddate>20180301</enddate><creator>Groger, Mirjam</creator><creator>Veletzky, Luzia</creator><creator>Lalremruata, Albert</creator><creator>Cattaneo, Chiara</creator><creator>Mischlinger, Johannes</creator><creator>Zoleko-Manego, Rella</creator><creator>Endamne, Lilian</creator><creator>Klicpera, Anna</creator><creator>Kim, Johanna</creator><creator>Nguyen, The</creator><creator>Flohr, Lena</creator><creator>Remppis, Jonathan</creator><creator>Matsiegui, Pierre-Blaise</creator><creator>Adegnika, Ayôla A</creator><creator>Agnandji, Selidji T</creator><creator>Kremsner, Peter G</creator><creator>Mordmüller, Benjamin</creator><creator>Mombo-Ngoma, Ghyslain</creator><creator>Ramharter, Michael</creator><general>American Society for Microbiology</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20180301</creationdate><title>Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon</title><author>Groger, Mirjam ; Veletzky, Luzia ; Lalremruata, Albert ; Cattaneo, Chiara ; Mischlinger, Johannes ; Zoleko-Manego, Rella ; Endamne, Lilian ; Klicpera, Anna ; Kim, Johanna ; Nguyen, The ; Flohr, Lena ; Remppis, Jonathan ; Matsiegui, Pierre-Blaise ; Adegnika, Ayôla A ; Agnandji, Selidji T ; Kremsner, Peter G ; Mordmüller, Benjamin ; Mombo-Ngoma, Ghyslain ; Ramharter, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a418t-25ac8a9761b81f0f5da4f4e594d047e50a597b5897c41278145a88d886769fe73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Antimalarials</topic><topic>Artemether</topic><topic>Clinical Therapeutics</topic><topic>Lumefantrine</topic><topic>Plasmodium malariae</topic><topic>Plasmodium ovale</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Groger, Mirjam</creatorcontrib><creatorcontrib>Veletzky, Luzia</creatorcontrib><creatorcontrib>Lalremruata, Albert</creatorcontrib><creatorcontrib>Cattaneo, Chiara</creatorcontrib><creatorcontrib>Mischlinger, Johannes</creatorcontrib><creatorcontrib>Zoleko-Manego, Rella</creatorcontrib><creatorcontrib>Endamne, Lilian</creatorcontrib><creatorcontrib>Klicpera, Anna</creatorcontrib><creatorcontrib>Kim, Johanna</creatorcontrib><creatorcontrib>Nguyen, The</creatorcontrib><creatorcontrib>Flohr, Lena</creatorcontrib><creatorcontrib>Remppis, Jonathan</creatorcontrib><creatorcontrib>Matsiegui, Pierre-Blaise</creatorcontrib><creatorcontrib>Adegnika, Ayôla A</creatorcontrib><creatorcontrib>Agnandji, Selidji T</creatorcontrib><creatorcontrib>Kremsner, Peter G</creatorcontrib><creatorcontrib>Mordmüller, Benjamin</creatorcontrib><creatorcontrib>Mombo-Ngoma, Ghyslain</creatorcontrib><creatorcontrib>Ramharter, Michael</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Antimicrobial agents and chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Groger, Mirjam</au><au>Veletzky, Luzia</au><au>Lalremruata, Albert</au><au>Cattaneo, Chiara</au><au>Mischlinger, Johannes</au><au>Zoleko-Manego, Rella</au><au>Endamne, Lilian</au><au>Klicpera, Anna</au><au>Kim, Johanna</au><au>Nguyen, The</au><au>Flohr, Lena</au><au>Remppis, Jonathan</au><au>Matsiegui, Pierre-Blaise</au><au>Adegnika, Ayôla A</au><au>Agnandji, Selidji T</au><au>Kremsner, Peter G</au><au>Mordmüller, Benjamin</au><au>Mombo-Ngoma, Ghyslain</au><au>Ramharter, Michael</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon</atitle><jtitle>Antimicrobial agents and chemotherapy</jtitle><stitle>Antimicrob Agents Chemother</stitle><addtitle>Antimicrob Agents Chemother</addtitle><date>2018-03-01</date><risdate>2018</risdate><volume>62</volume><issue>3</issue><issn>0066-4804</issn><eissn>1098-6596</eissn><abstract>Treatment recommendations for
and
malaria are largely based on anecdotal evidence. The aim of this prospective study, conducted in Gabon, was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated
or
species monoinfections or mixed
infections. Patients with microscopically confirmed
,
, or mixed-species malaria with at least one of these two
species were treated with an oral, fixed-dose combination of artemether-lumefantrine for 3 consecutive days. The primary endpoints were per-protocol PCR-corrected adequate clinical and parasitological response (ACPR) on days 28 and 42. Tolerability and safety were recorded throughout the follow-up period. Seventy-two participants (42 male and 30 female) were enrolled; 62.5% of them had PCR-corrected mixed
infections. Per protocol, PCR-corrected ACPR rates were 96.6% (95% confidence interval [CI], 91.9 to 100) on day 28 and 94.2% (95% CI, 87.7 to 100) on day 42. Considering
species independently from their coinfecting species, day 42 ACPR rates were 95.5% (95% CI, 89.0 to 100) for
, 100% (exact CI, 84.6 to 100) for
, 100% (exact CI, 76.8 to 100) for
, and 90.9% (95% CI, 70.7 to 100) for
Study drug-related adverse events were generally mild or moderate. In conclusion, this clinical trial demonstrated satisfying antimalarial activity of artemether-lumefantrine against
,
,
, and mixed
infections, with per-protocol efficacies of 90% to 100% and without evident tolerability or safety concerns. (This trial was registered in the clinical study database ClinicalTrials.gov under the identifier NCT02528279.).</abstract><cop>United States</cop><pub>American Society for Microbiology</pub><pmid>29311086</pmid><doi>10.1128/AAC.01758-17</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0066-4804 |
ispartof | Antimicrobial agents and chemotherapy, 2018-03, Vol.62 (3) |
issn | 0066-4804 1098-6596 |
language | eng |
recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5826119 |
source | EZB-FREE-00999 freely available EZB journals; PubMed Central |
subjects | Antimalarials Artemether Clinical Therapeutics Lumefantrine Plasmodium malariae Plasmodium ovale |
title | Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T21%3A00%3A17IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Prospective%20Clinical%20Trial%20Assessing%20Species-Specific%20Efficacy%20of%20Artemether-Lumefantrine%20for%20the%20Treatment%20of%20Plasmodium%20malariae,%20Plasmodium%20ovale,%20and%20Mixed%20Plasmodium%20Malaria%20in%20Gabon&rft.jtitle=Antimicrobial%20agents%20and%20chemotherapy&rft.au=Groger,%20Mirjam&rft.date=2018-03-01&rft.volume=62&rft.issue=3&rft.issn=0066-4804&rft.eissn=1098-6596&rft_id=info:doi/10.1128/AAC.01758-17&rft_dat=%3Cproquest_pubme%3E1989551563%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1989551563&rft_id=info:pmid/29311086&rfr_iscdi=true |