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The Norwegian Antibiotics for Pneumonia in Children (NAPIC) Study
EU CTIS ID: 2024-512001-39-01
What this study is testing
Determine the effect of amoxicillin versus placebo in preschool children with pneumonia.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 12-59 months
- Fever. Temperature ≥38.0 at inclusion or reported within the last 24 hours
- Tachypnoe, age specific
- ≥1 sign of lower airway inflammation; Cough (at inclusion or reported within the last 6 hours), Chest retractions (jugular, intercostally or subcoastally), grunting respiration, nasal flaring, crepitations by pulmonary auscultation, hypoxia (SpO2 ≤90%)
- Weight between 6.0 and 28.0 kg
You likely can't join if
- Clinical suspicion of bacterial pneumonia based upon a temperature ≥39.0 C and at least one of the following: bronchial breathing sounds, unilaterally decreased breth sounds or unilateral percussion dullness, pulmonary lobar consilidation and/or radiological suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial.
- Evidence of any bacterial infection requiring systemic antibiotics, including, but not exclusively: clinical septicaemia, urinary tract infection, meningitis
- Systemic antibiotics received within the last 7 days
- History of ant serious underlying disease including: haematolocigal or oncological: immunodeficiency, congenital heart disease, neuromuscular impairment, development disorder, including Dwns syndrome, bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or severe chronic lung diseases
- Acute lower obstructive airways (prolonged expiration and generalised expiratory wheeze)
- Stridor (inspiratory)
See the full eligibility criteria
- Age 12-59 months
- Fever. Temperature ≥38.0 at inclusion or reported within the last 24 hours
- Tachypnoe, age specific
- ≥1 sign of lower airway inflammation; Cough (at inclusion or reported within the last 6 hours), Chest retractions (jugular, intercostally or subcoastally), grunting respiration, nasal flaring, crepitations by pulmonary auscultation, hypoxia (SpO2 ≤90%)
- Weight between 6.0 and 28.0 kg
- Clinical suspicion of bacterial pneumonia based upon a temperature ≥39.0 C and at least one of the following: bronchial breathing sounds, unilaterally decreased breth sounds or unilateral percussion dullness, pulmonary lobar consilidation and/or radiological suspicion of empyema on chest x-ray if this is obtained prior to inclusion in the trial.
- Evidence of any bacterial infection requiring systemic antibiotics, including, but not exclusively: clinical septicaemia, urinary tract infection, meningitis
- Systemic antibiotics received within the last 7 days
- History of ant serious underlying disease including: haematolocigal or oncological: immunodeficiency, congenital heart disease, neuromuscular impairment, development disorder, including Dwns syndrome, bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or severe chronic lung diseases
- Acute lower obstructive airways (prolonged expiration and generalised expiratory wheeze)
- Stridor (inspiratory)
- Known or suspected allergy against the investigational product or any of the constituents
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.