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

Study acronym: ToolCAP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 31, 2026 → Jul 30, 2027
See other at-risk trials from Ecole Polytechnique Fédérale de Lausanne

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jul 31, 2026 to Jul 30, 2027 Show 8 more changesShow less
    • Sponsor changed: University of Bern to Ecole Polytechnique Fédérale de Lausanne
    • Enrollment increased: 3500 → 4894 participants
    • Study completion pushed from Dec 2026 to Aug 31, 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 17 entries
    • Study description revised
    • Site details revised at 4 of 9 sites
    • Collaborators: details revised at 1 of 6 entries
  2. Minor Site details revised at 1 of 9 sitesv5
  3. Minor Site details revised at 3 of 9 sitesv4
  4. Minor Study sites: 6 to 9v3
  5. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Nov 2024 to Apr 4, 2025
    • Primary completion date: May 2026 to Jul 31, 2026
    • Study completion date: May 2026 to Dec 2026
    • Site details revised at 6 of 6 sites
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06670833
Lead Sponsor Ecole Polytechnique Fédérale de Lausanne
Collaborators: University of Witwatersrand, South Africa, Cheikh Anta Diop University, Senegal, University of Stellenbosch, National Institute for Medical Research, Tanzania, Swiss Tropical & Public Health Institute, Muhimbili University of Health and Allied Sciences
Conditions
(from sponsor)
Pneumonia, Pneumonia Childhood, Pneumonia - Bacterial, Pediatrics, LRTI, IMCI Guidelines
Related terms Pneumonia, Pneumonia, Bacterial
Enrollment 4,894 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov