Amoxicillin trihydrate for Community-acquired pneumonia|Lower respiratory tract infection

Inclusion criteria

• {"criterion_text":"- Age 12-59 months"}
• {"criterion_text":"- Fever. Temperature ≥38.0 at inclusion or reported within the last 24 hours"}
• {"criterion_text":"- Tachypnoe, age specific"}
• {"criterion_text":"- ≥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%)"}
• {"criterion_text":"- Weight between 6.0 and 28.0 kg"}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Evidence of any bacterial infection requiring systemic antibiotics, including, but not exclusively: clinical septicaemia, urinary tract infection, meningitis"}
• {"criterion_text":"- Systemic antibiotics received within the last 7 days"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Acute lower obstructive airways (prolonged expiration and generalised expiratory wheeze)"}
• {"criterion_text":"- Stridor (inspiratory)"}
• {"criterion_text":"- Known or suspected allergy against the investigational product or any of the constituents"}

Primary endpoints

• {"endpoint_text":"- Determined by 21 days after treatment start as:\tTherapy failure","definition_or_measurement_approach":"Determined 21 days after treatment start; endpoint assessed as occurrence of therapy failure by day 21."}

Secondary endpoints

• {"endpoint_text":"- Therapy failure leading to intravenous antibiotic therapy","definition_or_measurement_approach":"Occurrence of therapy failure resulting in initiation of intravenous antibiotic therapy (event-based)."}
• {"endpoint_text":"- Duration of fever","definition_or_measurement_approach":"Measured as duration (time) of fever; specific measurement approach not detailed in available data."}
• {"endpoint_text":"- Duration of symptoms, assessed by parent/guardian","definition_or_measurement_approach":"Measured as duration of symptoms as reported by parent/guardian; specific instruments not specified."}
• {"endpoint_text":"- Bacterial presence in airways","definition_or_measurement_approach":"Presence of bacteria in airway samples; specific sampling and laboratory methods not provided in available data."}
• {"endpoint_text":"- Presence of resistant bacteria","definition_or_measurement_approach":"Assessment of resistance in detected bacterial isolates; detailed methods not provided."}
• {"endpoint_text":"- Resistance genes (bacteria)","definition_or_measurement_approach":"Detection of bacterial resistance genes; specific molecular methods not provided."}

Norway

Earliest CTIS Part Ii Submission Date

01-12-2024

Latest Decision Or Authorization Date

10-12-2024

Processing Time Days

9

Number Of Sites

10

Number Of Participants

500

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"Clinical therapy research in the specialist health services,South-Eastern Norway Regional Health Au","duties_or_roles":"Monetary support","organisation_type":""}