LAB-Net trained all sites in the PediCAP study

Microbiologists, technicians and study investigators from local teams in South Africa, Uganda, Zambia and Zimbabwe attended online training sessions that were conducted in November and December. Prior to the training, LAB-Net developed a sample collection and management manual and sampling instructions for the sites. The local study teams were provided with sample kits that were prepared and shipped by the central laboratory at the University of Antwerp.

All attendees were required to complete an online evaluation that was developed in collaboration with The Global Health Network (TGHN), WP6 of the PediCAP project. All attendees completed the evaluation successfully. All five sites were activated for the microbiology sub-study in PediCAP, and the Ugandan site has already started recruiting.

LAB-Net will gradually organize the transport of samples from sites and will start the analysis in the second half of 2022. This will include DNA extraction, sequencing, and bioinformatics analysis to discover multidrug-resistant pathogens. The goal is to shed more light on the impact of the co-amoxiclav treatment on the stool microbiome in children. Dissemination of the results is expected towards the end of the trial, in the last quarter of 2023.

ABOUT PediCAP

PediCAP (Paediatric Community Acquired Pneumonia) is a project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) comprising 13 partner institutions in Europe and Africa. PediCAP is a six-year project that began in April 2019 and will run until 2025. It includes a main clinical trial and two parallel sub-studies: a Phase II pharmacokinetics study comparing different ratios for co-amoxiclav, as well as a microbiology sub-study in which LAB-Net is involved. The study is a complex duration response factorial trial randomising children to 4 vs 5 vs 6 vs 7 vs 8 days of amox vs co-amox focusing on the rapid oral step down of children admitted with severe pneumonia. The microbiology study will examine the impact of different hospital durations on the acquisition of hospital acquired MDR pathogens, and the impact of amoxicillin and co-amox on the microbiome. The goal of the trial is to identify the best choice of drug dose and duration to maximise clinical efficacy while minimising toxicity, selection of resistance and impact on the microbiome. The study will run in five sites in South Africa, Uganda, Zambia and Zimbabwe. In addition, the PediCAP project includes various capacity building activities to enhance potential sites in low- and middle-income settings to participate in clinical studies.