A Phase 4 interventional study of Quick response: Amoxicillin for 3 days and Delayed response: Amoxicillin for 5 days in Community-acquired Pneumonia and Child, Only, sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 3 Months to 59 Months. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by University Hospital, Montpellier · Phase 4, Interventional, and Treatment
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.
Introduction:
The World Health Organization (WHO) has declared antimicrobial resistance to be one of the 10 greatest threats to public health. As such, it has issued recommendations for children for the diagnosis and treatment of pneumonia with amoxicillin for 3 days. However, this strategy includes viral infections and therefore cannot be extrapolated directly to countries with a high level of access to healthcare, where the aim is to treat only bacterial pneumonia and for the shortest possible time to limit the emergence of resistant bacteria. Thus, our study proposes to use a definition of pneumonia adapted to countries with a high level of access to healthcare and to test an adaptive treatment regimen including a clinical reassessment at D3, which will propose a treatment limited to 3 days in case of rapid response and 5 days in case of delayed response.
Aim:
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.
Methods:
As the hypothesis is not that a shorter antibiotic regimen is more effective in this indication, a non-inferiority trial is the most appropriate design to assess whether this efficacy is broadly comparable with the reference regimen. The primary endpoint chosen is the one already used in an international clinical trial on this disease in children, which has been agreed upon.
In order to meet the objective of the study, 1100 patients will be included.
Given the non-inferiority design, data will be analyzed on a per protocol basis for the primary analysis. The per-protocol population will be defined by radiologist of pneumonia diagnosis, at least one dose of amoxicillin, and having primary endpoint assessment data at 7 days. Non-inferiority will be declared if the lower bound of the confidence interval of the difference in failure rate between the 3-day and 5-day arms is less than 3.5%.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 1,100 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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Child with a diagnosis of community-acquired alveolar pneumonia defined as an association of 3 major criteria + at least 3/5 minor criteria:
Exclusion Criteria:
Antibiotic therapy for 3 to 5 days depending on response
Drug: Quick response: Amoxicillin for 3 days · Drug: Delayed response: Amoxicillin for 5 days
Antibiotic therapy for 5 to 7 days depending on response
Drug: Quick response: Amoxicillin for 5 days · Drug: 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 rapid response\*: Immediate stop of antibiotherapy (after 9 complete doses) \*A rapid response is determined by a favorable clinical evolution (MASCOT 2002 study)
Also known as: Quick response (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 delayed response: Continuation of antibiotic therapy for up to 5 days
Also known as: Delayed response (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)
Also known as: Quick response (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 7 days
Also known as: Delayed response (7 days)
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
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
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
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
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
Plan to share: No
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University Hospital, Montpellier