Data on pharmacokinetics of praziquantel and inflammatory markers in preschool age children from Albertine Region of Western Uganda treated for Schistosoma mansoni – User Guide

Persistent Identifier

10.17037/DATA.00005306

Alternative title

Praziquantel pharmacokinetic parameters and inflammatory markers in Schistosoma mansoni infection.

Description

Anonymized dataset of 184 preschool age children (PSAC) treated for Schistosoma mansoni from Albertine Region of Western Uganda. Participants were recruited between April 2021 and February 2023. Dataset includes demographic variables, schistosomiasis infection parameters, anthropometric data, praziquantel pharmacokinetic variables as well as intestinal and systemic inflammatory markers.

Data collection methods

Demographic data was obtained through completion of interview questionnaires. Anthropometric measurements (weight and height) yielded primary data that was used to calculate height-for-age z-scores, weight-for-age z-scores and weight-for-height z-scores. Intestinal and systemic markers were obtained from stool, urine and plasma samples through Enzyme-Linked Immunosorbent Assay (ELISA) and High-Pressure Liquid Chromatography (HPLC). Plasma praziquantel was quantified using ultra-high performance liquid chromatography mass spectrometry from which Area Under the Curve (AUC), maximum concentration (Cmax) and time to maximum concentration (Tmax) were calculated.

Data analysis and preparation

Data cleaning was done in REDCap database where the initial entry was made and exported to STATA 19 for analysis. Descriptive analysis was done followed by crude and adjusted regression models to assess association between schistosomiasis infection status and inflammatory markers.

Geographic regions

Hoima District and Buliisa District in Albertine Region of Uganda.

Key dates

Data was collected between April 2021 and February 2023. Laboratory assays were conducted between April 2021 and April 2024, followed by statistical analysis from May 2024 to July 2024.

Quality controls

Staff were trained in data management, and data was entered into REDCap database with checks. During data collection, the Data Manager and ran data quality checks and raised queries for the attention of the field data collectors, who verified any discrepancies and responded accordingly.

Population

Schistosoma mansoni-infected preschool age children aged 12-47 months from the Praziquantel for children under age four years: A Phase II PK/PD driven dose finding trial (PIP trial).

Privacy

Anonymized electronic data was entered in REDCap and each data collector used a password-protected account. Hard copies such as consent forms were kept in lockable cabinets with restricted access.

Ethics

Keywords

Schistosomiasis, Environmental Enteric Dysfunction, inflammation, Praziquantel, Pharmacokinetics

Language of written material

English

Project information

Praziquantel pharmacokinetic data from Praziquantel for children under age four years: A Phase II PK/PD driven dose finding trial (PIP trial) was used. Preschool children aged 12-47 months received praziquantel at 40mg/kg or 80mg/kg.

Creators

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