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New treatment option for Pneumonia
Official title Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP
ClinicalTrials.gov ID: NCT06670833
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 12
You may be able to join if
- Cough OR Difficulty Breathing AND,
- One of the below: Fast breathing (tachypnoea) \> 50/minute (2-12 months) \> 40/minute (1-\ 25/minute (5-12 years) OR Lower chest wall indrawing
You likely can't join 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...
- 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...
See the full eligibility criteria
- Cough OR Difficulty Breathing AND,
- One of the below: Fast breathing (tachypnoea) \> 50/minute (2-12 months) \> 40/minute (1-\ 25/minute (5-12 years) OR Lower chest wall indrawing
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Dakar, Senegal
- Parow, Cape Town, South Africa
- Parktown, Johannesburg, South Africa
- Acornhoek, Mpumalanga, South Africa
- Mbombela, South Africa
- Ifakara, Morogoro, Tanzania
- Dar es Salaam, Tanzania
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 days to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dakar, Senegal; Parow, Cape Town, South Africa; Parktown, Johannesburg, South Africa; Acornhoek, Mpumalanga, South Africa; Mbombela, South Africa; Ifakara, Morogoro, Tanzania and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.