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Part 1: Document Description
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Citation |
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Title: |
Replication Data for: Mosquitocidal effect and pharmacokinetics of different ivermectin dose regimens in preparation for the BOHEMIA trial: An open label, randomized, controlled clinical trial |
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Identification Number: |
doi:10.7910/DVN/MO6MVV |
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Distributor: |
Harvard Dataverse |
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Date of Distribution: |
2023-03-27 |
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Version: |
1 |
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Bibliographic Citation: |
Kamau, Yvonne N.; Tuwei, Mercy; Ominde, Kelly; Ngama, Mwanajuma; Karisa, Jonathan; Babu, Lawrence; Muturi, Martha; Lewa, Frida; Mure, Festus; Mwatasa, Mwaganyuma; Wanjiku, Caroline; Adetifa, Jane; Kern, Charlotte; Duthaler, Urs; Hammann, Felix; Rabinovich, Regina; Chaccour, Carlos; Maia, Marta F., 2023, "Replication Data for: Mosquitocidal effect and pharmacokinetics of different ivermectin dose regimens in preparation for the BOHEMIA trial: An open label, randomized, controlled clinical trial", https://doi.org/10.7910/DVN/MO6MVV, Harvard Dataverse, V1, UNF:6:uc/JmWg1jvQcYkGALdUKfw== [fileUNF] |
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Citation |
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Title: |
Replication Data for: Mosquitocidal effect and pharmacokinetics of different ivermectin dose regimens in preparation for the BOHEMIA trial: An open label, randomized, controlled clinical trial |
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Identification Number: |
doi:10.7910/DVN/MO6MVV |
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Authoring Entity: |
Kamau, Yvonne N. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Tuwei, Mercy (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Ominde, Kelly (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Ngama, Mwanajuma (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Karisa, Jonathan (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Babu, Lawrence (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Muturi, Martha (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Lewa, Frida (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Mure, Festus (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Mwatasa, Mwaganyuma (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Wanjiku, Caroline (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Adetifa, Jane (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Kern, Charlotte (Division of Clinical Pharmacology & Toxicology, Department of Internal Medicine, University Hospital Bern, Switzerland) |
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Duthaler, Urs (Division of Clinical Pharmacology & Toxicology, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland) |
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Hammann, Felix (Division of Clinical Pharmacology & Toxicology, Department of Internal Medicine, University Hospital Bern, Switzerland) |
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Rabinovich, Regina (ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain) |
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Chaccour, Carlos (ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain) |
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Maia, Marta F. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya) |
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Distributor: |
Harvard Dataverse |
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Access Authority: |
Maia, Marta F. |
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Depositor: |
Kamau, Yvonne N. |
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Date of Deposit: |
2023-03-24 |
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Holdings Information: |
https://doi.org/10.7910/DVN/MO6MVV |
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Study Scope |
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Keywords: |
Medicine, Health and Life Sciences, pharmacokinetics, non compartmental analysis, AUC, Cmax, tmax |
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Abstract: |
<p>This is a replication dataset for the manuscript titled: "<a href="">Mosquitocidal effect and pharmacokinetics of different ivermectin dose regimens in preparation for the BOHEMIA trial: An open-label, randomized, controlled clinical trial</a>."</p> <p>The related study aimed to provide evidence to support the decision of the dose for the BOHEMIA trials by comparing the pharmacokinetics and mosquito-killing effect of 300 mcg/kg of ivermectin given on three consecutive days to that of 400 mcg/kg of ivermectin given once and validating its sampling method (dried blood spots (DBS)) as a way of assessing concentrations in the field in an East African population. Lastly, we evaluated the mosquitocidal effect of trial comparator albendazole, another anti-infective chosen for its deworming properties which are similar to those of ivermectin. </p> <p>The study is registered with Pan African Clinical Trial Registry identification (PACTR) No.: PACTR202001893991170</p> |
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Kind of Data: |
Embargoed |
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Kind of Data: |
Clinical Trial |
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Notes: |
<p><strong>Data Access: </strong>Embargoed</p> |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Notes: |
Access to files will be public once the manuscript has been published. |
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Other Study Description Materials |
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Related Publications |
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Citation |
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Identification Number: |
https://doi.org/10.1186/s13063-023-07098-2 |
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Bibliographic Citation: |
Chaccour, C., Casellas, A., Hammann, F., Ruiz-Castillo, P., Nicolas, P., Montaña, J., Mael, M., Selvaraj, P., Duthaler, U., Mrema, S. and Kakolwa, M., 2023. BOHEMIA: Broad One Health Endectocide-based Malaria Intervention in Africa—a phase III cluster-randomized, open-label, clinical trial to study the safety and efficacy of ivermectin mass drug administration to reduce malaria transmission in two African settings. Trials, 24(1), pp.1-16. |
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File Description--f6989842 |
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File: 2023-03-13-dataset_dfPK300cov_DBS_actualtime.tab |
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Notes: |
UNF:6:fWkRtY03DXETXEuMMjD7VQ== |
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File Description--f6989843 |
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File: 2023-03-13-dataset_dfPK300cov_plasma_actualtime.tab |
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Notes: |
UNF:6:NFtUVnI+/AvEuAtxxKG2gg== |
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File Description--f6989844 |
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File: 2023-03-13-dataset_dfPK400cov_DBS_actualtime.tab |
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Notes: |
UNF:6:hfX5arSaQQiZKX1fW8flDQ== |
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File Description--f6989845 |
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File: 2023-03-13-dataset_dfPK400cov_plasma_actualtime.tab |
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Notes: |
UNF:6:j+i/Iux1hbrG+nkV7jsz8Q== |
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Label: |
NCA_Data_Dictionary.pdf |
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Notes: |
application/pdf |
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Label: |
NCA_data_readme.txt |
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Notes: |
text/plain |
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Label: |
NCA_PK1x400_DBS_Summary.txt |
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Text: |
NCA analysis results summary |
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Notes: |
text/plain |
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Label: |
NCA_PK1x400_plasma_Summary.txt |
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Text: |
NCA analysis results summary |
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Notes: |
text/plain |
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Label: |
NCA_PK3x300_DBS_Summary.txt |
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Text: |
NCA analysis results summary |
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Notes: |
text/plain |
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Label: |
NCA_PK3x300_plasma_Summary.txt |
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Text: |
NCA analysis results summary |
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Notes: |
text/plain |