In July 2022, the EMPIRICAL study also hit its 50% recruitment milestone. The study is evaluating whether empirical treatment against cytomegalovirus and TB improves the survival of HIV-infected infants with severe pneumonia.
Children with HIV infections are highly vulnerable to respiratory infections, and there is growing evidence that TB and cytomegalovirus – a common virus that only rarely causes disease – are major unrecognised causes of death in such children. As diagnostics for these infections are generally not available in many parts of sub-Saharan Africa, the EMPIRICAL trial is evaluating whether empirical treatment against TB and cytomegalovirus improves survival of HIV-infected infants with severe pneumonia.
Patients are being enrolled at 19 EMPIRICAL sites in Malawi, Mozambique, Uganda, Zambia and Zimbabwe. In July 2022, patient number 312 out of 614 was recruited. The trial’s external Data and Safety Monitoring Board reviewed the initial data and found no safety issues, recommending that the study continue as planned.
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Pneumonia is the biggest killer of young children worldwide, responsible for the deaths of nearly 750,000 children under the age of 5 each year. Mortality rates are highest in sub-Saharan Africa. Many of these infections are bacterial and can be treated with antibiotics.
The PediCAP study is assessing whether children hospitalised for severe or very severe pneumonia can be safely switched from injectable to oral antibiotics. Currently, WHO recommends that such children receive injectable antibiotics for at least five days, as these antibiotics cover a wider range of bacterial pathogens than oral amoxicillin alone. However, this means that children stay in hospital longer, incur high healthcare costs, and are at risk of acquiring drug-resistant infections.
The PediCAP trial is comparing the effectiveness of co-amoxiclav or amoxicillin, two possible oral step-down treatments, given for different lengths of time. In August 2022, it hit its 50% recruitment milestone, having enrolled more than 500 children in Uganda, South Africa, Zambia and Zimbabwe; it reached its 75% target in early January 2023, with more than 750 children enrolled.
Two projects focused on treatment of lower respiratory tract infections reached important recruitment milestones in 2022.
Optimising antimicrobial treatments for children