Stopping Pneumonia Antibiotherapy Regimen Early (NCT06291012) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Stopping Pneumonia Antibiotherapy Regimen Early
France1,100 participantsStarted 2024-09-01
Plain-language summary
The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days.
Who can participate
Age range3 Months – 59 Months
SexALL
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Inclusion Criteria:
* Child with a diagnosis of community-acquired alveolar pneumonia defined as an association of 3 major criteria + at least 3/5 minor criteria:
* Major criteria: Fever (\> 38°C), Polypnea and Chest x-ray
* Minor criteria: Localized crackles, C-Reactive Protein (CRP) \> 80mg/L, Alteration of general condition, Cough and Pulmonary condensation syndrome.
* Child with an episode that began less than 7 days before inclusion, in the community.
* Absence of hospitalization criteria
Exclusion Criteria:
* Pre-existing underlying pathology: acquired or hereditary immune deficiencies, cardiac pathologies, chronic respiratory failure or pulmonary malformations, neurological or muscular diseases at risk of respiratory decompensation, serious chronic kidney diseases and nephrotic syndromes, sickle cell anemia, diabetes, chronic liver diseases, oncological pathologies and hematological, organ and hematopoietic stem cell transplants, inflammatory and/or autoimmune diseases receiving immunosuppressive treatment, people infected with HIV, obese people with a body mass index (BMI) ≥ the 97th percentile
* Asthma with basic treatment
* Wheezing during the episode
* Presence of pleural effusion on radiography
* Presence of toxin signs
* Antibiotic therapy within 48 hours before inclusion
* Anti-inflammatory therapy within 48 hours before inclusion
* Allergy or contraindication to penicillin
* History of more than 2 bacterial pneumonias per year
* Associated infection req…