RecruitingNot ApplicableNCT06670833

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

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

Sponsor

University of Bern

Enrollment

3,500 participants

Start Date

Apr 4, 2025

Study Type

INTERVENTIONAL

Conditions

Pneumonia Pneumonia Childhood

Summary

The ToolCAP study aims to see if using ultrasound to look at the lungs when children have symptoms of a lung infection will safely allow doctors to improve how they treat those infections. The study will also look at if it's possible to improve how doctors decide which children need antibiotics. * Lung infections are the most common reason for children to go to the clinic/hospital. * Doctors usually give an antibiotic to every child with a lung infection. * Lung infections can be caused by 2 different types of germs - bacteria or viruses. * Antibiotics only work against bacteria and not against viruses. Lung infections caused by viruses don't need antibiotics as the body fights them by itself. * Lots of research now shows that only 1 in 4 children with a lung infection actually needs an antibiotic, as the rest only have a viral infection causing the symptoms. * This means that 3 in 4 children get an antibiotic when they don't need it. * Taking too many antibiotics can cause problems for children as it can cause diseases like diabetes or asthma. * Nowadays, due to too many people using too many antibiotics, experts are starting to worry that bacteria are starting to become resistant (stronger than the antibiotic). * Ultrasound of the lungs appears to be a way of safely looking at the lungs to see if there is an infection and may help doctors better decide who needs an antibiotic. This study includes children aged 2 months-12 years who come to the hospital with a lung infection. Children who are very unwell or who have already had 2 days of antibiotic treatment will not be allowed to be in the study.

Eligibility

Min Age: 60 DaysMax Age: 12 Years

Inclusion Criteria3

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 Criteria10

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.

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