Lower Respiratory Tract Infection (LRTI)

This trial investigates whether a single dose of dexamethasone will prevent recurrent wheezing in children at high-risk for asthma admitted to hospital with a lower respiratory tract infection (LRTI). Eligible children will be identified and enrolled upon hospital admission or during hospitalisation and allocated to receive either dexamethasone 0.6 mg/kilogram body weight or the similar number of placebo tablets (allocation ratio 1:1). The follow-up is 12 months and comprises scheduled on-site examinations by physician and study nurse, scheduled phone contacts, and registrations of new LRTI-episodes (if any). Nasopharyngeal swabs and blood will be collected at specified visits. The children will be invited to a follow-up study at school age for lung function assessments.

Lower respiratory tract infections (LRTIs) are any infections below the vocal cords which affect the airways or the air sacs in the lungs. They include pneumonia, bronchitis and chest infections and are usually caused by viruses such as influenza, COVID-19 or Respiratory Syncytial Virus (RSV), or by bacteria such as pneumococcus. LRTIs are common, particularly in older adults; in the UK approximately 15% of people aged over 65 years will experience a chest infection each year and many of those will need in-patient treatment. People who have had a chest infection may experience slow recovery after their infection. Patients often report that their quality of life is worse after an infection (for example persistent fatigue, reduced physical functioning, and mental health challenges) and this can affect the return to usual activities. However, there have not been many studies that have looked at how the quality of life changes in the months following a chest infection, and why some people take longer to recover. In this study, the investigators will use a well-recognised questionnaire to measure quality of life for up to one year in adults who have been admitted to hospital with a chest infection. The findings will help the investigators to assess how long-term quality of life is affected after a chest infection and what factors may affect it. The results will also permit calculation of the costs faced by patients during recovery from a chest infection, in financial terms. These results will feed into studies looking at ways of improving recovery after a chest infection.

Lower respiratory tract infections (LRTIs) remain a leading cause of hospitalisation and death among young children in Africa. Although viral infections account for a substantial proportion of LRTIs, antibiotics are frequently prescribed because distinguishing between viral and bacterial infections can be challenging. This contributes to unnecessary antibiotic exposure and the rising global public health challenge of antimicrobial resistance. This pragmatic, unblinded randomised controlled study will evaluate whether the combination of point-of-care (POC) C-reactive protein (CRP) testing and the PREPARE clinical severity score can safely reduce antibiotic use among children aged 2 to 24 months hospitalised with LRTI at Chris Hani Baragwanath Academic Hospital (CHBAH), South Africa. Participants will be randomly assigned in a 1:1 ratio to either the intervention group, where antibiotic decisions are guided by serial POC CRP measurements and repeated PREPARE severity assessments, or a control group receiving routine clinical care. The primary objective of the study is to compare antibiotic use during hospitalisation between the intervention and control groups. Secondary objectives are to evaluate the safety of this approach by comparing mortality, hospital readmission within 28 days, adverse events, need for invasive ventilation, duration of hospitalisation, and other clinical outcomes between study groups. In addition, the study will compare healthcare-related costs, including antibiotic expenditure and costs associated with hospitalisation. A parallel mixed-methods component will explore clinician attitudes, beliefs, and determinants of antibiotic prescribing for children hospitalised with LRTI using surveys, focus groups discussions, and individual interviews informed by the Theoretical Domains Framework (TDF). Findings will help identify behavioural and system-level factors that influence antibiotic prescribing and inform future antimicrobial stewardship interventions. This study aims to generate evidence on whether biomarker-guided and risk-stratified care can safely optimise antibiotic use among young African children hospitalised with LRTI while improving antimicrobial stewardship and reducing healthcare costs.

The goal of this clinical trial is to assess if BUCCALIN® works In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIS). It will also evaluate the safety of BUCCALIN®. The primary aim is to reduce the number of infection episodes in the treatment period (12 months) in the BUCCALIN® group versus the Placebo group. Patients diagnosed with RLRTIS will be screened for enrolment. Patients will be requested to provide informed consent before the start of the study related assessments. Eligible patients who meet the study inclusion and exclusion criteria will be randomized with a 1:1 ratio allocation to the 2 treatment groups. Researchers will compare BUCCALIN® (gastro-resistant tablets) to a placebo (gastro-resistant tablets containing only excipients) to treat RLRTIS. Patients who participate in the study will perform several study visits divided as reported below: * Run-in phase (12 months): patients will not receive any treatment. This phase is designed to increase adherence to the study and reduce loss to follow-up in the clinical trial. During this phase, patients should experience ≥ 2 episodes of RTIs to be eligible for the Treatment period. * Treatment period (12 months): patients will receive BUCCALIN® or Placebo treatment for 12 consecutive months (3 days per month, posology as per authorized SmPC). * Follow-up period (12 months): patients will not receive any treatment. This phase is designed to observe how patients respond to treatments.

The goal of this observational study is to learn about the causes, severity, and long-term effects of respiratory tract infections (RTIs) in young children from birth to five years of age in Colombia and Panamá. The main questions it aims to answer are: How often do respiratory infections occur in children under two years old, and which viruses or bacteria cause them? Why do some children develop more severe infections than others? Do early infections or vaccinations change how the immune system responds to future illnesses? How do viruses and bacteria interact in the respiratory tract to influence disease severity and long-term respiratory health? Researchers will follow newborns from birth until age five to understand how respiratory infections develop and affect children's health over time. Participants will not receive any experimental treatment. Families who join the study will: Be contacted twice a week through a phone app or phone calls to check for symptoms of respiratory infection. Attend in-person visits if their child becomes ill and every six months for routine follow-up. Provide nasal and blood samples during illness episodes so researchers can identify the viruses or bacteria causing infection and study how the immune system responds. This study began in May 2024 and is being conducted in Cali, Colombia, and Panamá City, Panamá. The research team plans to continue to include participants and continue active follow-up until the children reach five years of age. The information collected will help scientists and health professionals understand how different pathogens cause respiratory infections, what factors increase the risk of severe illness, and how early infections may influence long-term lung health. The study's findings will support future efforts to prevent and treat respiratory diseases in young children.

Antibiotic resistance is driven by overuse, especially for viral respiratory infections. Procalcitonin (PCT), a biomarker for bacterial infections, helps guide antibiotic therapy more precisely, reducing unnecessary use and improving outcomes. Studies, including large trials and economic models across several countries, show PCT-guided treatment lowers mortality, antibiotic exposure, therapy duration and related complications, potentially reducing hospital costs despite initial testing expenses.