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

RecruitingNAAges 60 Days - 12 YearsAllEcole Polytechnique Fédérale de Lausanne
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In plain words

What the trial is, and whether it could suit you

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 ch

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Lung ultrasound
  • Standard of Care (SOC)
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Where

9 sites
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, South Africa
University of Witwatersrand, MRC/Wits Rural Public Health and Health Transitions Research Unit
Parktown, South Africa
Tintswalo Hospital
Acornhoek, South Africa
Themba Hospital
Mbombela, South Africa
Ifakara Health Institute
Ifakara, Tanzania

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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