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

NCT06670833 | Recruiting DMC

• 2 other identifiers: 2023-01534Horizon Europe Regulation
• Study Type: interventional
• Target: 3,500
• Locations: 3 countries
• Sites: 9

Brief Summary

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

Pneumonia; Pneumonia Childhood; Pneumonia - Bacterial; Pediatrics; LRTI; IMCI Guidelines

Keywords

Lung ultrasound (LUS); Lung auscultation; Pediatric pneumonia

Outcome Measures

Primary Outcomes (2)

• Percentage of children prescribed antibiotic treatment

  Day 1

• Percentage of children with clinical failure

  Clinical failure is defined as the development of any if the following criteria: 1. Any time before or on D8: \*WHO IMCI danger sign (inability to drink/breastfeed, vomiting everything, convulsions with this illness, lethargy/unconsciousness) \* New or worsening sever respiratory distress (such as grunting, head nodding, severe chest indrawing) \* Secondary hospitalization (defined as hospitalization occurring after discharge from in-patient admission or outpatient visit) related to a deterioration of the presenting complaint on D1 \* Change in level of care (e.g. admission to intensive care unit, transfer to higher level of care) \* Need for respiratory support (e.g. high flow nasal cannula, CPAP) \* Death due to any medical cause (i.e. except trauma) ii. At D8 outcome assessment: \* Report from the caregiver of non-resolution/worsening of illness

  Day 8

Secondary Outcomes (17)

• Percentage of children prescribed antibiotic treatment

  Day 8

• Percentage of adverse drug reactions related to routine antibiotic treatment (i.e., anaphylactic reaction, severe diarrhoea, or generalized severe rash)

  Day 8

• Percentage of participants cured

  Day 8

• Percentage of patients admitted to hospital on D1

  Day 1

• Duration of inpatient admissions

  Day 29

Study Arms (2)

Routine Care Group

ACTIVE COMPARATOR

This group receives normal routine care. No intervention.

Other: Standard of Care (SOC)

Intervention Group

EXPERIMENTAL

Participants will undergo lung ultrasound and the ultrasound images/videos will be reviewed by an expert and the findings, along with advice on whether or not an antibiotic should be used. This means in this group there is a chance the participant will not be given an antibiotic if the ultrasound shows there is no need for it.

Other: Lung ultrasound

Interventions

Lung ultrasound OTHER

Portable lung ultrasound

Also known as: LUS

Intervention Group

Standard of Care (SOC) OTHER

SOC antibiotic treatment

Routine Care Group

Eligibility Criteria

• Age: 60 Days - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• University of Witwatersrand, South Africa: collaborator
• Cheikh Anta Diop University, Senegal: collaborator
• University of Stellenbosch: collaborator
• National Institute for Medical Research, Tanzania: collaborator
• Swiss Tropical & Public Health Institute: collaborator
• Muhimbili University of Health and Allied Sciences: collaborator

Study Sites (9)

Université Cheikh Anta Diop

Dakar, 10700, Senegal

RECRUITING

Centre National Hospitalier d'Enfants Albert Royer

Dakar, 25755, Senegal

RECRUITING

Centre De Santé Gaspard Kamara

Dakar, PG2RJH6, 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, 2193, South Africa

RECRUITING

Tintswalo Hospital

Acornhoek, Mpumalanga, 1375, South Africa

RECRUITING

Themba Hospital

Mbombela, 1245, South Africa

RECRUITING

Ifakara Health Institute

Ifakara, Morogoro, Tanzania

NOT YET RECRUITING

Muhimbili University of Health and Allied Sciences

Dar es Salaam, Tanzania

RECRUITING

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Stephen Tollman, MD, PhD

  University of the Witwatersrand, School of Public Health (WHC)

  STUDY DIRECTOR

Central Study Contacts

Kristina Keitel, MD, PhD

CONTACT

+41763432520; Kristina.Keitel@witshealth.co.za

Jacques du Toit, MD

CONTACT

+27636874914; jacques.dutoit1@wits.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 1, 2024
• Study Start: April 4, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TA (2); ZA (4); SE (3)