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SPARE : Evaluation of a therapeutic strategy to reduce the duration of antibiotic therapy for community-acquired alveolar pneumonia in children: a randomized controlled non-inferiority trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512236-30-00
Acronym
RECHMPL22_0399
Enrollment
1100
Registered
2024-08-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired alveolar pneumonia in children

Brief summary

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.

Detailed description

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., Adverse effects attributable to antibiotics during and after taking amoxicillin, up to D30, Compliance throughout the duration of antibiotic therapy, up to D7 or D30 maximum, The duration of antibiotic therapy collected at visits on D7 and D30

Interventions

Sponsors

Centre Hospitalier Universitaire De Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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., Adverse effects attributable to antibiotics during and after taking amoxicillin, up to D30, Compliance throughout the duration of antibiotic therapy, up to D7 or D30 maximum, The duration of antibiotic therapy collected at visits on D7 and D30

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026