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SPARE : Stopping Pneumonia Antibiotherapy Regimen Early
EU CTIS ID: 2024-512236-30-00
What this study is testing
The aim of this trial is to demonstrate the non-inferiority of a strategy of antibiotic treatment with amoxicillin 80-100 mg/kg/day for 3 days in the case of a rapid response or 5 days in the case of a delayed response, versus antibiotic treatment for 5 days in the case of a rapid response or 7 days in the case of a delayed response for the management of non-severe community-acquired alveolar pneumonia in children between 3 and 59 months, in terms of the rate of treatment failure at 7 days.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Child aged between 3 months and 59 months inclusive
- 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.
- Child with an episode that began less than 7 days before inclusion, in the community
- Absence of hospitalization criteria
You likely can't join if
- 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
- Anti-inflammatory therapy within 48 hours before inclusion
- Allergy or contraindication to penicillin
- History of more than 2 bacterial pneumonias per year (with background treatment)
- Associated infection requiring more than 3 days of antibiotics
- Asthma with basic treatment
See the full eligibility criteria
- Child aged between 3 months and 59 months inclusive
- 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.
- Child with an episode that began less than 7 days before inclusion, in the community
- Absence of hospitalization 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
- Anti-inflammatory therapy within 48 hours before inclusion
- Allergy or contraindication to penicillin
- History of more than 2 bacterial pneumonias per year (with background treatment)
- Associated infection requiring more than 3 days of antibiotics
- Asthma with basic treatment
- Patient whose legal representatives are unable to read/write in French
- Patient hospitalized within 15 days before inclusion
- Failure to obtain informed consent by the legal representative(s)
- Patient not affiliated with or not benefiting from a national health insurance scheme
- Patient participating in another interventional research involving human person
- Wheezing during the episode
- Presence of pleural effusion on radiography
- Presence of toxin signs
- Antibiotic therapy within 48 hours before inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.