Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 weakened immune system) - 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

Lung ultrasound

Portable lung ultrasound

OTHER

Standard of Care (SOC)

SOC antibiotic treatment

Locations (9)

Université Cheikh Anta Diop
Dakar, Senegal
Centre National Hospitalier d'Enfants Albert Royer
Dakar, Senegal
Centre De Santé Gaspard Kamara
Dakar, Senegal
Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University
Parow, Cape Town, South Africa
University of Witwatersrand, MRC/Wits Rural Public Health and Health Transitions Research Unit
Parktown, Johannesburg, South Africa
Tintswalo Hospital
Acornhoek, Mpumalanga, South Africa
Themba Hospital
Mbombela, South Africa
Ifakara Health Institute
Ifakara, Morogoro, Tanzania
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania