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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-12
SponsorUniversity of Bern

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Lung ultrasound

    Other intervention

    Portable lung ultrasound

  • Standard of Care (SOC)

    Other intervention

    SOC antibiotic treatment

Treatment groups

3,500 Participants
are divided into 2 treatment groups
Group A: Routine Care GroupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of children prescribed antibiotic treatment

Time frame
Day 1
2

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

Time frame
Day 8

Secondary outcomes

1

Percentage of children prescribed antibiotic treatment

Time frame
Day 8
2

Percentage of adverse drug reactions related to routine antibiotic treatment (i.e., anaphylactic reaction, severe diarrhoea, or generalized severe rash)

Time frame
Day 8
3

Percentage of participants cured

Cure is defined as caregiver-reported recovery from illness

Time frame
Day 8
4

Percentage of patients admitted to hospital on D1

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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