Actively Recruiting

Phase Not Applicable
Age: 60Days - 12Years
All Genders
NCT06670833

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

Led by University of Bern · Updated on 2025-06-18

3500

Participants Needed

9

Research Sites

86 weeks

Total Duration

On this page

Sponsors

U

University of Bern

Lead Sponsor

U

University of Witwatersrand, South Africa

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Days - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 2 months to 12 years with cough or difficulty breathing
  • Presence of fast breathing: >50 breaths/min (2-12 months), >40 breaths/min (1-<5 years), or >25 breaths/min (5-12 years)
  • Presence of lower chest wall indrawing
Not Eligible

You will not qualify if you...

  • Repeat visit or follow-up for treated lower respiratory infection within 28 days
  • Received antibiotic treatment for more than 48 hours at enrollment
  • WHO IMCI danger signs: inability to drink/breastfeed, vomiting everything, convulsions with this illness, lethargy/unconscious
  • Presence of jaundice
  • Oxygen saturation (SpO2) <88%
  • SpO2 <90% with severe respiratory distress or in children under 6 months
  • Need for non-invasive ventilatory support
  • Underlying diseases increasing risk of severe or unusual pneumonia
  • HIV positive and either under 12 months old, requiring admission, or uncontrolled on treatment
  • Caregiver unavailable or unwilling to provide informed consent

AI-Screening

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Trial Site Locations

Total: 9 locations

1

Université Cheikh Anta Diop

Dakar, Senegal, 10700

Actively Recruiting

2

Centre National Hospitalier d'Enfants Albert Royer

Dakar, Senegal, 25755

Actively Recruiting

3

Centre De Santé Gaspard Kamara

Dakar, Senegal, PG2RJH6

Actively Recruiting

4

Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University

Parow, Cape Town, South Africa

Actively Recruiting

5

University of Witwatersrand, MRC/Wits Rural Public Health and Health Transitions Research Unit

Parktown, Johannesburg, South Africa, 2193

Actively Recruiting

6

Tintswalo Hospital

Acornhoek, Mpumalanga, South Africa, 1375

Actively Recruiting

7

Themba Hospital

Mbombela, South Africa, 1245

Actively Recruiting

8

Ifakara Health Institute

Ifakara, Morogoro, Tanzania

Not Yet Recruiting

9

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

Actively Recruiting

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Research Team

K

Kristina Keitel, MD, PhD

CONTACT

J

Jacques du Toit, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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