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Antibiotic Therapy In Respiratory Tract Infections

NCT04166110 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2023-05-23

No results posted yet for this study

Summary

Primary aim: to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting.

Secondary aims: To compare the 2 study arms on:

1. Clinical success at late follow up (Day 30),
2. Duration of antibiotic treatment,
3. Frequency and severity of adverse events,
4. Patient's pneumonia symptoms and quality of life.

Conditions

  • Community-Acquired Pneumonia

Interventions

DRUG

Predetermined treatment duration

Antibiotic treatment duration left to the physician's judgement (following national guidelines, 7 to 14 days)

DRUG

Variable treatment duration

Treatment duration vary according to stability criteria reaching time Patients will self-monitor 2 times a day (in the morning and in the evening) using a set of connected devices, to monitor their vital signs before any treatment intake. After at least 3 days of treatment and stability criteria obtained for the last 24 hours (i.e. 3 vital signs recording), patients will stop the antibiotic treatment.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Aurélien DINH, MD · Unité des Maladies Infectieuses, Hôpital Raymond Poincaré, Garches

  • Anne-Claude CRÉMIEUX, MD, PhD · Service des maladies infectieuses, Hôpital Saint Louis, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT04166110 on ClinicalTrials.gov