Actively Recruiting
ToolCAP: Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia
Led by University of Bern · Updated on 2025-06-18
3500
Participants Needed
9
Research Sites
17 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
Researchers are evaluating how using lung ultrasound can help improve treatment decisions for children aged 2 months to 12 years who have symptoms of a lung infection. The study focuses on better identifying which children actually need antibiotics, aiming to reduce unnecessary antibiotic use that can cause health problems and contribute to antibiotic resistance. Lung infections are a leading cause of illness in children and are often treated with antibiotics even when caused by viruses, which do not respond to these drugs. Participants are randomly assigned to one of two groups: one receiving routine care without additional testing, and the other receiving lung ultrasound examinations. In the ultrasound group, experts review images to guide doctors on whether antibiotics are needed, potentially reducing antibiotic prescriptions if the infection appears viral. The study excludes children who are very sick or have already taken antibiotics for more than two days. The study also evaluates lung ultrasound's role in diagnosing tuberculosis and other lung conditions. During the study, children are assessed at the start and followed up through day 29 or 8 weeks depending on the outcomes measured. This includes monitoring antibiotic use, clinical improvement, hospital admissions, adverse reactions, and diagnoses like tuberculosis. Researchers collect data through clinical exams, ultrasound imaging, and other tests as needed. The goal is to see if lung ultrasound can safely reduce antibiotic use without harming health outcomes, with careful safety monitoring throughout the study period.
CONDITIONS
Brief Title
Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 months to 12 years
- Presence of cough or difficulty breathing
- Fast breathing as defined by age: over 50 breaths per minute (2-12 months), over 40 (1 to under 5 years), or over 25 (5-12 years), OR presence of lower chest wall indrawing
You will not qualify if you...
- Presenting for a repeat visit or follow-up of a treated lower respiratory tract infection within the last 28 days
- Received antibiotic treatment for more than 48 hours at enrollment
- WHO IMCI danger signs such as inability to drink/breastfeed, vomiting everything, convulsions, lethargy, or unconsciousness
- Presence of jaundice
- Oxygen saturation below 88%
- Oxygen saturation below 90% with severe respiratory distress or in children under 6 months
- Need for non-invasive ventilatory support like high-flow oxygen or CPAP
- Underlying diseases increasing risk of severe pneumonia or unusual pneumonia causes
- HIV positive children under 12 months, admitted for illness, or uncontrolled on treatment
- Caregiver not available or unwilling to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive either routine care or undergo lung ultrasound to help guide antibiotic use as part of pneumonia management.
1 baseline visit (in-person)
Duration - 8 to 29 days
Participants are monitored for clinical outcomes, including antibiotic use, health status, and any adverse events after treatment.
1 to 2 visits (in-person)
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
Research Team
K
Kristina Keitel, MD, PhD
J
Jacques du Toit, MD
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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