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

NCT05903352 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

  • Community-Acquired Pneumonia

Interventions

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).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Aurélien Dihn, MD, PhD · Infectious diseases department, Raymond-Poincaré Hospital - APHP

  • Jacques Ropers, PharmD · Clinical Research Unit Pitié Salpêtrière - Charles Foix, CHU La Pitié-Salpêtrière - APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-05
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05903352 on ClinicalTrials.gov