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Stopping Pneumonia Antibiotherapy Regimen Early

ConditionsCommunity-acquired PneumoniaChild, Only
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-59
SponsorUniversity Hospital, Montpellier

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quick response: Amoxicillin for 3 days

    Drug

    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

    Drug

    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

    Drug

    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

    Drug

    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

Treatment groups

1,100 Participants
are divided into 2 treatment groups
Group A: Short armExperimental treatment 2 interventions
Group B: Long armActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Therapeutic failure rate D7

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).

Time frame
Day 7

Secondary outcomes

1

Therapeutic failure rate on D30

Day 0 (D0) is defined as the 1st day of taking amoxicillin. Therapeutic failure 30 days after , 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.

Time frame
Day 30
2

Adverse effects

Occurrence of adverse effects attributable to antibiotics during and after taking amoxicillin. Day 0 (D0) is defined as the 1st day of taking amoxicillin.

Time frame
Day 0, Day 3, Day 7 and Day 30
3

Compliance

Compliance is recorded in a monitoring log, completed by the child's family, throughout the duration of antibiotic therapy. Day 0 (D0) is defined as the 1st day of taking amoxicillin.

Time frame
Day 7, or Day 30 in case of therapeutic failure
4

Duration of antibiotic therapy

The duration of antibiotic therapy is collected in a monitoring log completed by the patients' families, and during the interview at visits on D7 and D30. Day 0 (D0) is defined as the 1st day of taking amoxicillin.

Time frame
Day 7 and Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Direction Générale de l'Offre de Soins

Collaborator

Source ClinicalTrials.gov

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