LAB-Net Involved in Start-Up Activities for PediCAP

LAB-Net acts as the central laboratory for PediCAP and is in charge of:

• writing the sample collection and management manual for the study;
• training sites on laboratory-related topics;
• providing sites with sampling kits;
• coordinating and analyzing the collected stool samples and nasopharyngeal swabs from enrolled children.

In 2020, LAB-Net drafted the sample collection and management manual, and will shortly conduct a validation study for optimal freezing and storage of samples. Most of the study activities were put on hold or delayed due to the COVID-19 pandemic, but they gradually resumed and sites are expected to start recruiting in January and February 2021. The microbiology sampling will be performed in 5 sites within a sub-study in May.

In the following months, LAB-Net will continue working on the set up. A validation study will be performed to select the best transport medium for the collected swabs, in addition to the set-up of the biobank and laboratory database for PediCAP. Labels and sampling kits will be prepared and shipped, so that the sites are able to start sampling in the second half of 2021. LAB-Net will gradually organize transport of samples from sites and will start the analysis in the end of 2021. 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 around the end of the trial, in the last quarter of 2022.

ABOUT PediCAP

PediCAP (Paediatric Community Acquired Pneumonia) project is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) with 13 partner institutions from Europe and Africa. PediCAP is a 5-year project that started in April 2019 and will run until 2024. 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 focussing 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 trials goal is to identify the choice of drug dose and duration that maximises clinical efficacy, while minimising toxicity, selection of resistance and impact on the microbiome. The study and sub-studies will run in 5 sites in South Africa, Uganda, Zambia and Zimbabwe. In addition, the PediCAP project includes various capacity building activities to enhance the potential sites in low- and middle-income settings to participate in clinical studies.