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

Intervention / Treatment

• Other: Lung ultrasound
• Other: Standard of Care (SOC)

Primary Outcome Measures

• Percentage of children prescribed antibiotic treatment (Day 1)
• Percentage of children with clinical failure (Day 8)
  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

Countries

Senegal, South Africa, Tanzania

Locations and Investigators

• Université Cheikh Anta Diop, Dakar, Senegal (Recruiting)
  • Papa Moctar Faye, MD, PhD
  • Papa Moctar Faye, MD, PhD (Principal Investigator)
• Centre National Hospitalier d'Enfants Albert Royer, Dakar, Senegal (Recruiting)
  • Professor of Pediatrics
  • Professor of Psychiatry & Epidemiology, 00221775923706
  • Papa Moctar Faye, MD (Principal Investigator)
• Centre De Santé Gaspard Kamara, Dakar, Senegal (Recruiting)
  • Professor of Psychiatry & Epidemiology, MD
  • Mame Awa Pediatric Physician
  • Jean Augustin Diegane Tine
• Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Parow, South Africa (Recruiting)
  • Megan Palmer, MBChB, FCPaeds, MMed
  • Megan Palmer, MBChB, FCPaeds, MMed (Principal Investigator)
• University of Witwatersrand, MRC/Wits Rural Public Health and Health Transitions Research Unit, Parktown, South Africa (Recruiting)
  • Jacques du Toit, MD
  • Jacques du Toit, MD (Principal Investigator)
• Tintswalo Hospital, Acornhoek, South Africa (Recruiting)
  • Senior Pediatrician
  • Justin Wakeford
  • Jacques du Toit, MD (Principal Investigator)
• Themba Hospital, Mbombela, South Africa (Recruiting)
  • Justin Wakeford, MD
  • Jacques du Toit, MD (Principal Investigator)
• Ifakara Health Institute, Ifakara, Tanzania (Not yet recruiting)
  • Honorati Masanja, MD, PhD
  • Grace Mhalu
  • Honorati Masanja, MD, PhD (Principal Investigator)
• Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (Recruiting)
  • Karim P Manji, MD, PhD
  • Fatimah Dhalla, BSc
  • Karim P Manji, MD, PhD (Principal Investigator)

Study Officials

• Stephen Tollman, MD, PhD (Study Director) — University of the Witwatersrand, School of Public Health (WHC)