About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Cough OR Difficulty Breathing AND,
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Lung ultrasound
Other interventionPortable lung ultrasound
Standard of Care (SOC)
Other interventionSOC antibiotic treatment
Treatment groups
Trial outcomes
Primary outcomes
Percentage of children prescribed antibiotic treatment
Percentage of children with clinical failure
Clinical failure is defined as the development of any if the following criteria: 1. Any time before or on D8: \*WHO IMCI danger sign (inability to drink/breastfeed, vomiting everything, convulsions with this illness, lethargy/unconsciousness) \* New or worsening sever respiratory distress (such as grunting, head nodding, severe chest indrawing) \* Secondary hospitalization (defined as hospitalization occurring after discharge from in-patient admission or outpatient visit) related to a deterioration of the presenting complaint on D1 \* Change in level of care (e.g. admission to intensive care unit, transfer to higher level of care) \* Need for respiratory support (e.g. high flow nasal cannula, CPAP) \* Death due to any medical cause (i.e. except trauma) ii. At D8 outcome assessment: \* Report from the caregiver of non-resolution/worsening of illness
Secondary outcomes
Percentage of children prescribed antibiotic treatment
Percentage of adverse drug reactions related to routine antibiotic treatment (i.e., anaphylactic reaction, severe diarrhoea, or generalized severe rash)
Percentage of participants cured
Cure is defined as caregiver-reported recovery from illness
Percentage of patients admitted to hospital on D1
Sponsors and contacts
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University of Bern
Lead sponsor
University of Witwatersrand, South Africa
Collaborator
Cheikh Anta Diop University, Senegal
Collaborator
University of Stellenbosch
Collaborator
National Institute for Medical Research, Tanzania
Collaborator
Swiss Tropical & Public Health Institute
Collaborator
Muhimbili University of Health and Allied Sciences
Collaborator