Stopping Pneumonia Antibiotherapy Regimen Early

NCT06291012 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Montpellier

Phase

Phase 4

Started

2024-09-01

Last updated

2024-05-20

Condition(s) studied

Community-acquired PneumoniaChild, Only

Investigational drug(s) / intervention(s)

Quick response: Amoxicillin for 3 daysDelayed response: Amoxicillin for 5 daysQuick response: Amoxicillin for 5 daysDelayed response: Amoxicillin for 7 days

Quick response: Amoxicillin for 3 days: Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of rapid response\*: Immediate stop of antibiotherapy (after 9 complete doses) \*A rapid response is determined by a favorable clinical evolution (MASCOT 2002 study)

Delayed response: Amoxicillin for 5 days: Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of delayed response: Continuation of antibiotic therapy for up to 5 days

Quick response: Amoxicillin for 5 days: Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of rapid response\*: Continuation of antibiotherapy for up to 5 days \*A rapid response is determined by a favorable clinical evolution (MASCOT 2002 study)

Delayed response: Amoxicillin for 7 days: Once the diagnosis of community-acquired alveolar pneumonia has been made, the investigator taking charge of the child writes a prescription for amoxicillin at a dosage of 80-100 mg/kg/day in 3 oral doses (morning, noon and evening), for a period of 4 days, before delivery of treatment to the family. The investigator will carry out a clinical re-evaluation on day 3 (D3), during which he will decide on the final duration of treatment. In case of delayed response: Continuation of antibiotic therapy for up to 7 days

Study 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.

Eligibility

Sex

ALL

Min age

3 Months

Max age

59 Months

Healthy volunteers

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 requiring more than 3 days of antibiotics * Patient hospitalized within 15 days before inclusion * Failure to obtain informed consent by the legal representative(s) * Patient whose legal representatives are unable to read/write french language * Patient not affiliated with or not benefiting from a national health insurance scheme * Patient participating in another interventional research involving human person

Primary outcome measure(s)

Therapeutic failure rate D7 — Day 7
Day 0 (D0) is defined as the 1st day of taking amoxicillin. 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. This definition is based on that already used in a clinical trial carried out in Israel (6. Greenberg D, Givon-Lavi N, Sadaka Y, Ben-Shimol S, Bar-Ziv J, Dagan R. Short-course Antibiotic Treatment for Community-acquired Alveolar Pneumonia in Ambulatory Children. Pediatr Infect Dis J. 2014 Feb;33(2):136-42).

Trial sites (1)

Facility	City	Region	Status
CHU de Montpellier	Montpellier	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06291012 on ClinicalTrials.gov ↗ ← All trials in France