SPARE : Stopping Pneumonia Antibiotherapy Regimen Early

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Montpellier

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2024-08-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Montpellier University Hospital · DGOS

External identifiers

EU CT number

2024-512236-30-00

ClinicalTrials.gov

NCT06291012

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

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.

Secondary objectives 4

1. To compare between the 2 antibiotic therapy strategies, the rate of therapeutic failure at 30 days of antibiotic therapy (D30).
2. To compare between the 2 antibiotic therapy strategies, the occurrence of adverse drug effects up tu 30 days
3. To compare between the 2 antibiotic therapy strategies, compliance throughout the duration of antibiotic therapy with amoxicillin.
4. To compare between the 2 antibiotic therapy strategies, duration of antibiotic therapy.

Conditions and MedDRA coding

Community-acquired alveolar pneumonia in children

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Child aged between 3 months and 59 months inclusive
2. 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.
3. Child with an episode that began less than 7 days before inclusion, in the community
4. Absence of hospitalization criteria

Exclusion criteria 15

1. 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
2. Patient hospitalized within 15 days before inclusion
3. Failure to obtain informed consent by the legal representative(s)
4. Patient not affiliated with or not benefiting from a national health insurance scheme
5. Patient participating in another interventional research involving human person
6. Wheezing during the episode
7. Presence of pleural effusion on radiography
8. Presence of toxin signs
9. Antibiotic therapy within 48 hours before inclusion
10. Anti-inflammatory therapy within 48 hours before inclusion
11. Allergy or contraindication to penicillin
12. History of more than 2 bacterial pneumonias per year (with background treatment)
13. Associated infection requiring more than 3 days of antibiotics
14. Asthma with basic treatment
15. Patient whose legal representatives are unable to read/write in French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 4

1. 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.
2. Adverse effects attributable to antibiotics during and after taking amoxicillin, up to D30
3. Compliance throughout the duration of antibiotic therapy, up to D7 or D30 maximum
4. The duration of antibiotic therapy collected at visits on D7 and D30

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Montpellier

Sponsor organisation

Centre Hospitalier Universitaire De Montpellier

Address

Pavillon 32, 39 Avenue Charles Flahault 39 Avenue Charles Flahault

City

Montpellier Cedex 5

Postcode

34295

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Montpellier

Contact name

Sylvine BROCHOT

Public contact point

Organisation

Centre Hospitalier Universitaire De Montpellier

Contact name

Sylvine BROCHOT

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications