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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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
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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Description

This is a replication dataset for the manuscript titled: "Mosquitocidal effect and pharmacokinetics of different ivermectin dose regimens in preparation for the BOHEMIA trial: An open-label, randomized, controlled clinical trial."

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.

The study is registered with Pan African Clinical Trial Registry identification (PACTR) No.: PACTR202001893991170

Subject Medicine, Health and Life Sciences
Keyword pharmacokinetics, non compartmental analysis, AUC, Cmax, tmax
Related Publication 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.doi: https://doi.org/10.1186/s13063-023-07098-2
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NCA_Data_Dictionary.pdf
NCA_Data_Dictionary.pdf
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Published Mar 27, 2023
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MD5: 30550d041e0aac0bd820dca1a28e1864
DocumentationVariable Codebook/Data Dictionary
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NCA_data_readme.txt
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Published Mar 27, 2023
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DocumentationReadme
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2023-03-13-dataset_dfPK300cov_DBS_actualtime.tab
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Metadata Released Mar 27, 2023Was embargoed until 2023-12-26
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25 Variables, 72 Observations UNF:6:fWkRtY03DXETXEuMMjD7VQ==
participants' ivermectin concentration over time
Datacsv
2023-03-13-dataset_dfPK300cov_plasma_actualtime.tab
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Metadata Released Mar 27, 2023Was embargoed until 2023-12-26
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25 Variables, 102 Observations UNF:6:NFtUVnI+/AvEuAtxxKG2gg==
participants' ivermectin concentration over time
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2023-03-13-dataset_dfPK400cov_DBS_actualtime.tab
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Metadata Released Mar 27, 2023Was embargoed until 2023-12-26
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25 Variables, 132 Observations UNF:6:hfX5arSaQQiZKX1fW8flDQ==
participants' ivermectin concentration over time
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2023-03-13-dataset_dfPK400cov_plasma_actualtime.tab
Tabular Data - 32.0 KB
Metadata Released Mar 27, 2023Was embargoed until 2023-12-26
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25 Variables, 180 Observations UNF:6:j+i/Iux1hbrG+nkV7jsz8Q==
participants' ivermectin concentration over time
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NCA_PK1x400_DBS_Summary.txt
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MD5: 60c526dac3c22f3a39495aeece344a0c
NCA analysis results summary
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NCA_PK1x400_plasma_Summary.txt
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NCA analysis results summary
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NCA_PK3x300_DBS_Summary.txt
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MD5: 78db985cb2e5c48b8019a13ec82a0c0f
NCA analysis results summary
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NCA_PK3x300_plasma_Summary.txt
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MD5: 6137631114f1feec394fac86e023dcb9
NCA analysis results summary
Datatxt
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