Improving treatment of pneumonia in children using lung ultrasound
ToolCAP: Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia
This study is testing if using lung ultrasound can help doctors treat pneumonia in kids better and reduce the need for unnecessary antibiotics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3500 (estimated) |
| Ages | 60 Days to 12 Years |
| Sex | All |
| Sponsor | University of Bern Academic / other |
| Drugs / interventions | radiation |
| Locations | 9 sites (Dakar and 8 other locations) |
| Trial ID | NCT06670833 on ClinicalTrials.gov |
What this trial studies
The ToolCAP initiative aims to enhance the management of pediatric community-acquired pneumonia by utilizing lung ultrasound to assess lung infections in children. This approach seeks to determine whether ultrasound can help doctors make better decisions regarding antibiotic prescriptions, as many children with lung infections do not require antibiotics. The study will involve children presenting with symptoms of lung infections, and it will compare the outcomes of those receiving standard care versus those assessed with ultrasound. The goal is to reduce unnecessary antibiotic use and improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children presenting with cough or difficulty breathing, along with specific respiratory rate criteria.
Not a fit: Patients who are experiencing severe respiratory distress or have been treated with antibiotics for more than 48 hours prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate treatment of pneumonia in children, reducing unnecessary antibiotic prescriptions and improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using ultrasound for diagnosing pneumonia, suggesting that this approach may be effective, though this specific application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dakar and 8 other locations
- Université Cheikh Anta Diop — Dakar, Senegal (Recruiting)
- Centre National Hospitalier d'Enfants Albert Royer — Dakar, Senegal (Recruiting)
- Centre De Santé Gaspard Kamara — Dakar, Senegal (Recruiting)
- Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University — Parow, Cape Town, South Africa (Recruiting)
- University of Witwatersrand, MRC/Wits Rural Public Health and Health Transitions Research Unit — Parktown, Johannesburg, South Africa (Recruiting)
- Tintswalo Hospital — Acornhoek, Mpumalanga, South Africa (Recruiting)
- Themba Hospital — Mbombela, South Africa (Recruiting)
- Ifakara Health Institute — Ifakara, Morogoro, Tanzania (Not_yet_recruiting)
- Muhimbili University of Health and Allied Sciences — Dar es Salaam, Tanzania (Recruiting)
Study contacts
- Study coordinator: Kristina Keitel, MD, PhD
- Email: Kristina.Keitel@witshealth.co.za
- Phone: +41763432520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.