NCT05903352

Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting. As the secondary objectives, the study aims * To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of: * Persistence of cure at Day 30 of antibiotic treatment * All-cause mortality rate on Day 30 of antibiotic treatment * Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment. * To compare between the 2 study arms at Day 30 of antibiotic treatment: * The duration of antibiotic treatment; * The length of hospital stay; * The frequency and severity of adverse events during the 30 days after the start of treatment. * To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.

Detailed description

Recent studies have suggested that community-acquired pneumonia (CAP) can be successfully treated with short-course antibiotic regimen when clinical improvement is rapidly obtained. Even if clinical response is obtained in 3 days in the majority of cases, it can vary widely among patients suggesting "one duration does not fit all". An individualised duration of therapy depending on the patient's response could help to ensure bacterial eradication while avoiding unnecessary antibiotic exposure and thus reduce antibiotic resistance. At present, this strategy has never been tested. This is a phase III, pragmatic, non-inferiority randomised (1:1) national multicentre trial. Population of study participants will be patients admitted to hospital with suspected CAP and in need for antibiotics. There is no need to establish a DSMB for this trial. The antibiotic treatments prescribed during this study are treatments used in current practice, with well-known adverse drug reactions. Furthermore, a 3-day treatment duration has already been studied in 2 previous randomized clinical trials, showing its safety for hospitalized CAP. Statistical analysis: Statistical inference for non-inferiority will be based on the confidence intervals (CI) of the difference in Day 15 cure proportions \[proportion in reference arm - proportion in experimental arm\] accounting for randomisation stratification factors (centre and delay from Day 0 to Day S (≤ 3 days or \> 3 days). The inferiority hypothesis will be rejected and non-inferiority will be claimed if the upper bound of the 95%CI of the difference is ≤ 10%. Secondary efficacy endpoints evaluating the evolution of symptoms will be analysed using either a GMM or a GEE for categorical and continuous variables, respectively. Other quantitative variables will be compared using the Student t-test (or a non-parametric test if the distribution remains skewed following transformation), while categorical variables will be analysed using either the Chi-squared or the Fisher-exact tests. All statistical tests will be performed with a level of significance of 5%, except the primary endpoint which be analysed with a 2.5% level of significance.

Conditions

• Community-Acquired Pneumonia

Interventions

Type	Name	Description
OTHER	Stop antibiotic	Stop the antibiotic treatment on day S (stability criteria reached for 24 h or within 48 hours after the start of antibiotic treatment).
DRUG	Continue the antimicrobial treatment	Continue the antimicrobial treatment for a duration predetermined by the investigator (usual practice, at least 5 days of treatment in total).

Timeline

• Start date: 2024-02-05
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2023-06-15
• Last updated: 2025-03-20

Locations

1 site across 1 country: France