Amoxicillin trihydrate for Community-acquired alveolar pneumonia

Inclusion criteria

• {"criterion_text":"- Child aged between 3 months and 59 months inclusive"}
• {"criterion_text":"- 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 Focus of condensation on Chest x-ray * Minor criteria: Localized crackles, C-Reactive Protein (CRP) > 80mg/L, Alteration of general condition, Cough and Pulmonary condensation syndrome."}
• {"criterion_text":"- Child with an episode that began less than 7 days before inclusion, in the community"}
• {"criterion_text":"- Absence of hospitalization criteria"}

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Anti-inflammatory therapy within 48 hours before inclusion"}
• {"criterion_text":"- Allergy or contraindication to penicillin"}
• {"criterion_text":"- History of more than 2 bacterial pneumonias per year (with background treatment)"}
• {"criterion_text":"- Associated infection requiring more than 3 days of antibiotics"}
• {"criterion_text":"- Asthma with basic treatment"}
• {"criterion_text":"- Patient whose legal representatives are unable to read/write in French"}
• {"criterion_text":"- Patient hospitalized within 15 days before inclusion"}
• {"criterion_text":"- Failure to obtain informed consent by the legal representative(s)"}
• {"criterion_text":"- Patient not affiliated with or not benefiting from a national health insurance scheme"}
• {"criterion_text":"- Patient participating in another interventional research involving human person"}
• {"criterion_text":"- Wheezing during the episode"}
• {"criterion_text":"- Presence of pleural effusion on radiography"}
• {"criterion_text":"- Presence of toxin signs"}
• {"criterion_text":"- Antibiotic therapy within 48 hours before inclusion"}

Primary endpoints

• {"endpoint_text":"- The rate of therapeutic failure on day 7 (D7) defined by: - A change in antibiotherapy necessary before D7 due to a lack of satisfactory clinical response or clinical deterioration of the pneumonia. - A decision to resume or continue antibiotic therapy after D7 in connection with the pneumonia. - Hospitalization or death due to clinical deterioration related to community-acquired pneumonia.","definition_or_measurement_approach":"Defined by: a change in antibiotherapy necessary before D7 due to lack of satisfactory clinical response or clinical deterioration; a decision to resume or continue antibiotic therapy after D7 in connection with the pneumonia; hospitalization or death due to clinical deterioration related to community-acquired pneumonia."}

Secondary endpoints

• {"endpoint_text":"- Therapeutic failure rate on Day 30 (D30), defined by: - The occurrence of hospitalization linked to the initial episode. - An abnormal check-up chest x-ray at 1 month with persistent pneumonia. - The occurrence of complications of pneumonia (severe sepsis, pleurisy, pulmonary sequelae). - Relapse, defined by the development of signs of pneumonia 6 to 14 days after the respiratory rate returns to normal.","definition_or_measurement_approach":"Defined by hospitalization linked to the initial episode; abnormal chest x-ray at 1 month with persistent pneumonia; occurrence of pneumonia complications (severe sepsis, pleurisy, pulmonary sequelae); relapse as development of signs 6–14 days after normalisation of respiratory rate."}
• {"endpoint_text":"- Adverse effects attributable to antibiotics during and after taking amoxicillin, up to D30","definition_or_measurement_approach":"Occurrence of adverse effects attributable to antibiotics up to day 30."}
• {"endpoint_text":"- Compliance throughout the duration of antibiotic therapy, up to D7 or D30 maximum","definition_or_measurement_approach":"Assessment of adherence during the antibiotic therapy period, up to D7 (or up to D30 in case of therapeutic failure)."}
• {"endpoint_text":"- The duration of antibiotic therapy collected at visits on D7 and D30","definition_or_measurement_approach":"Duration of antibiotic therapy recorded at visits on day 7 and day 30."}

France

Earliest CTIS Part Ii Submission Date

12-07-2024

Latest Decision Or Authorization Date

30-08-2024

Processing Time Days

49

Number Of Sites

10

Number Of Participants

1100

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Montpellier University Hospital","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"DGOS","duties_or_roles":"Source of monetary support","organisation_type":""}