Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP

Launched by UNIVERSITY OF BERN · Oct 31, 2024

Keywords

ClinConnect Summary

The ToolCAP study is a research trial that aims to improve how doctors manage lung infections in children, specifically focusing on pneumonia. It will explore whether using ultrasound to look at the lungs can help doctors better decide when a child really needs antibiotics. Many children with lung infections are given antibiotics, but research shows that most of them actually have viral infections, which don’t require antibiotics. By using ultrasound, doctors may be able to safely identify which children truly need treatment, reducing the unnecessary use of antibiotics and helping prevent antibiotic resistance.

To participate in the study, children aged 2 months to 12 years who have a cough or difficulty breathing and meet certain criteria may be eligible. For instance, they need to show fast breathing or other signs of respiratory distress. However, children who are very unwell, have already been on antibiotics for more than 48 hours, or have other serious health conditions will not be included. If your child takes part in the study, they will undergo an ultrasound of their lungs, which is a safe and painless procedure, and the findings will help guide their treatment. This study aims to ensure that children receive the right care for their lung infections while minimizing unnecessary medication.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cough OR Difficulty Breathing AND,
• * One of the below:
• • Fast breathing (tachypnoea) \> 50/minute (2-12 months) \> 40/minute (1-\<5 years) \> 25/minute (5-12 years) OR Lower chest wall indrawing
• Exclusion Criteria:
• • Presenting for repeat visit/follow-up of a treated lower respiratory tract infection (index illness / non-acute) or enrolled in the study within the preceding 28 days.
• • Received antibiotic treatment for more than 48 hours at the time of enrolment.
• • WHO IMCI danger signs (inability to drink/breastfeed, vomiting everything, convulsions with this illness, lethargy/unconscious).
• • Presence of jaundice.
• • Hypoxaemia with oxygen saturation (SpO2) \<88%
• • Oxygen saturation (SpO2) \<90% (or country-specific / altitude-adjusted thresholds) i) With signs of severe respiratory distress (such as nasal flaring, grunting, etc.) OR ii) In children \< 6 months
• • Requiring non-invasive ventilatory support (i.e., high-flow, bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP))
• • Underlying disease associated with increased risk of severe pneumonia or pneumonia of unusual aetiology (e.g., WHO acute malnutrition requiring antibiotics as per local guidelines, severe immunodeficiency)
• • HIV positive participant that is either i) less than 12 months old; OR ii) requires admission for this illness; OR iii) known to be uncontrolled on treatment (with a documented VL \>1000c/ml in the previous 6 months)
• • Caregiver unavailable at the time of enrolment, or unwilling, to provide informed consent.