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Part 1: Document Description
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Citation |
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Title: |
Data for: Arterolane–piperaquine–mefloquine versus arterolane–piperaquine and artemether–lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a single-centre, open-label, randomised, non-inferiority trial |
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Identification Number: |
doi:10.7910/DVN/AJTQUO |
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Distributor: |
Harvard Dataverse |
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Date of Distribution: |
2021-11-23 |
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Version: |
1 |
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Bibliographic Citation: |
Hamaluba, Mainga; van der Pluijm, Rob W.; Weya, Joseph; Njuguna, Patricia; Ngama, Mwanajuma; Kalume, Peter; Mwambingu, Gabriel; Ngetsa, Caroline; Wambua, Juliana; Boga, Mwanamvua; Mturi, Neema; Lal, Altaf A.; Khuroo, Arshad; Taylor, Walter R.J.; Gonçalves, Sónia; Miotto, Olivo; Dhorda, Mehul; Mutinda, Brian; Mukaka, Mavuto; Waithira, Naomi; Hoglund, Richard M.; Imwong, Mallika; Tarning, Joel; Day, Nicholas P.J.; White, Nicholas J.; Bejon, Philip; Dondorp, Arjen M., 2021, "Data for: Arterolane–piperaquine–mefloquine versus arterolane–piperaquine and artemether–lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a single-centre, open-label, randomised, non-inferiority trial", https://doi.org/10.7910/DVN/AJTQUO, Harvard Dataverse, V1, UNF:6:sw9vELH54Z98BR/YYmYd5w== [fileUNF] |
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Citation |
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Title: |
Data for: Arterolane–piperaquine–mefloquine versus arterolane–piperaquine and artemether–lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a single-centre, open-label, randomised, non-inferiority trial |
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Subtitle: |
TACT |
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Alternative Title: |
Comparison of Arterolane-piperaquine Versus Arterolane-piperaquine+Mefloquine Versus Artemether-lumefantrine in Kenyan Children (TACTKenya) |
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Identification Number: |
doi:10.7910/DVN/AJTQUO |
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Authoring Entity: |
Hamaluba, Mainga (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK) |
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van der Pluijm, Rob W. (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Weya, Joseph (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Njuguna, Patricia (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK) |
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Ngama, Mwanajuma (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Kalume, Peter (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Mwambingu, Gabriel (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Ngetsa, Caroline (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Wambua, Juliana (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Boga, Mwanamvua (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Mturi, Neema (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Lal, Altaf A. (Sun Pharmaceutical Industries, Gurugram, India) |
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Khuroo, Arshad (Sun Pharmaceutical Industries, Gurugram, India) |
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Taylor, Walter R.J. (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Gonçalves, Sónia (Wellcome Sanger Institute, Hinxton, UK) |
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Miotto, Olivo (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK MRC Centre for Genomics and Global Health, Big Data Institute, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Wellcome Sanger Institute, Hinxton, UK) |
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Dhorda, Mehul (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Asia-Pacific Regional Centre, WorldWide Antimalarial Resistance Network, Bangkok, Thailand) |
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Mutinda, Brian (Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Mukaka, Mavuto (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Waithira, Naomi (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Hoglund, Richard M. (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Imwong, Mallika (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Tarning, Joel (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Day, Nicholas P.J. (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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White, Nicholas J. (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Bejon, Philip (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK) |
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Dondorp, Arjen M. (Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand) |
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Distributor: |
Harvard Dataverse |
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Access Authority: |
Hamaluba, Mainga |
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Access Authority: |
The Data Governance Committee |
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Depositor: |
Hamaluba, Mainga |
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Date of Deposit: |
2021-06-09 |
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Holdings Information: |
https://doi.org/10.7910/DVN/AJTQUO |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences |
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Abstract: |
<p>This data was generated by an open-label randomised controlled clinical trial compared the safety, tolerability, therapeutic efficacy and pharmacokinetics and pharmacodynamics of arterolane-piperaquine, arterolane-piperaquine plus mefloquine versus artemether-lumefantrine.in children with uncomplicated falciparum malaria in Kilifi, Kenya. The study provided an up to date insight on the current presence of antimalarial resistance in the site. In addition, all children were treated with a single low dose of primaquine, dosing is age based. The investigators recruited 219 patients aged 2 years to 12 years with acute uncomplicated falciparum malaria in Kilifi County Hospital. </p> <p>The trial is registered in <a href="https://clinicaltrials.gov/">ClinicalTrials.gov</a>, <a href="http://clinicaltrials.gov/show/NCT03452475">NCT03452475</a></p> |
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Kind of Data: |
Clinical Trial |
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Notes: |
<p><strong>Data Access: </strong>Restricted</p> <p>Access to these data requires submission of a formal request for consideration by our Data Governance Committee. </p> <strong>How to request</strong> <ol> <li>Download and complete the <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx"><strong>data request form</strong></a></li> <li> Email completed data request form to the Data Governance Committee at <a href="mailto:dgc@kemri-wellcome.org?cc=lmwango@kemri-wellcome.org?Subject=Data%20Access%20Request"><strong>dgc@kemri-wellcome.org</strong></a> </li> </ol> <p><strong>License: </strong><a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a> <a href="https://creativecommons.org/licenses/by/4.0/legalcode"><img src="https://i.creativecommons.org/l/by/3.0/88x31.png"><p> |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Citation Requirement: |
<p>Publications based on this data collection should acknowledge this source by means of bibliographic citation.</p> |
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Notes: |
<p>This data is licensed under the <a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a> <a href="https://creativecommons.org/licenses/by/4.0/legalcode"><img src="https://i.creativecommons.org/l/by/3.0/88x31.png"> </a> </p> |
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Deidentified, individual participant data that underlie this Article, along with a data dictionary describing variables in the dataset will be made available to researchers whose proposed purpose of use is approved by the Kenya Medical Research Institute Wellcome Trust Research Programme (KWTRP) data access committee. Data will be shared directly or through access on the Harvard Dataverse repository. To request the dataset, please send a signed data request form to dgc@kemri-wellcome.org [<a href="mailto:dgc@kemri-wellcome.org">dgc@kemri-wellcome.org</a> ]. <strong> <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx">Click to download Data Request Form</a></strong> |
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Other Study Description Materials |
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File Description--f4789145 |
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File: TACTArterolane_DD.tab |
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Notes: |
UNF:6:nAu4hNZnSj4YaPNQBVrEfw== |
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File Description--f4789144 |
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File: TACTArterolane_SCRN_DD.tab |
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Notes: |
UNF:6:Q9uz3CGQnCRmxgzgpA0hSA== |
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List of Variables: |
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Variables |
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f4789145 Location: |
Summary Statistics: StDev 136.72433017881275; Mean 237.25; Min. 1.0; Valid 472.0; Max. 473.0 Variable Format: numeric Notes: UNF:6:Z9+J2n4NPnRYsGTNnPwiGQ== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:V/2brGKvDxKkdm3ANxHB6g== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:9Od0s2AqYlcxXDqI6rIegw== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:3uYdDFrWKYBNS1IRc/nksg== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:gYk8fYAUL1B1z1t4NLSVrQ== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:5clPmUM45Ud6C6f59EFYQQ== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:JPvrG6uQmjhbw1cgoVEsoQ== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:aWCq7D/wDUr0BGXW2kSwmg== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:F4BeX1SOu/3GRA97cvBUWQ== |
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f4789145 Location: |
Variable Format: character Notes: UNF:6:fjDSavPi4Vjs2pSHdcpTig== |
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f4789144 Location: |
Summary Statistics: Min. 1.0; StDev 8.803408430829505; Mean 15.5; Valid 30.0; Max. 30.0 Variable Format: numeric Notes: UNF:6:NmI4sin12PckVHX8ui6HaQ== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:Gw5HB59g8Sxx6S7/eLbU1g== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:H6A683v8JHqe4c7s7wSfrg== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:aXEqOcCD1SdOSq0lPJU00Q== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:RvldAzOzQTdZzvfK8xEZQw== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:1qXdINewUOTTajvMADhs7A== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:rXDvhZLvRxSOwKNSFiskFA== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:Xxx3kQ+v7yALq4DbUL/EgA== |
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f4789144 Location: |
Summary Statistics: Mean 2517.0; Min. 34.0; StDev 3511.492275372395; Max. 5000.0; Valid 2.0 Variable Format: numeric Notes: UNF:6:2KBTY92HnuH894GX4htJTw== |
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f4789144 Location: |
Summary Statistics: Max. 250000.0; Min. 42.5; Valid 2.0; Mean 125021.25; StDev 176746.64325843647 Variable Format: numeric Notes: UNF:6:NjXltrdAKPLuiyEkSJBkEQ== |
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f4789144 Location: |
Variable Format: character Notes: UNF:6:g38Kwe6CacDTk0snviqmuA== |
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Label: |
CRF.zip |
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Notes: |
application/zip |
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Label: |
DATA.zip |
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Notes: |
application/zip |
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Label: |
PROTOCOL Version1.2 28Mar2018.pdf |
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Notes: |
application/pdf |
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Label: |
TACTArterolane_AnnotatedCRF.pdf |
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Notes: |
application/pdf |
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Label: |
TACTCV_SCR_AnnotatedCRF.pdf |
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Notes: |
application/pdf |