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Study of antibiotic combination therapy duration based on patient response for adults with community-acquired pneumonia

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Community Acquired Pneumonia (CAP), which is a lung infection that develops outside of hospitals or healthcare facilities. The research aims to determine if stopping antibiotic treatment based on a patient's clinical response is as effective as the standard predetermined treatment duration. The study will use several types of antibiotics including ampicillin, amoxicillin, ofloxacin, moxifloxacin, azithromycin, levofloxacin, pristinamycin, erythromycin, ciprofloxacin, and clarithromycin.

The treatment involves taking oral antibiotics, and patients will be monitored using connected devices to evaluate their response to the medication. The study will track how quickly patients recover from their pneumonia symptoms and measure the effectiveness of different antibiotic treatment durations. The treatment period may last between 5 to 14 days, depending on the specific antibiotic used and the patient's response to treatment.

Throughout the study, researchers will monitor patients' recovery for up to 30 days after starting treatment. They will assess various factors including the improvement of pneumonia symptoms, any side effects from the antibiotics, and the overall effectiveness of the individualized treatment approach. The study will also examine how different antibiotics affect the natural bacteria in the respiratory system and gut.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis and enrollment

    After being diagnosed with community acquired pneumonia (CAP), you will start antibiotic treatment if you meet the required conditions.

    The diagnosis is confirmed by at least 2 symptoms: fever above 38°C, difficulty breathing, cough, production of mucus, crackling sounds in lungs, or chest X-ray/CT scan showing infection.

  2. Step 2

    Treatment assignment

    You will receive one of the following oral antibiotics: ampicillin, amoxicillin (with or without clavulanic acid), ofloxacin, moxifloxacin, azithromycin, levofloxacin, pristinamycin, erythromycin, ciprofloxacin, or clarithromycin.

    The treatment duration will be determined either by your clinical response or by standard predetermined duration set by your physician.

  3. Step 3

    Monitoring period - Day 1-15

    Your condition will be monitored through connected devices at home.

    The primary assessment of your recovery will occur on day 15 after starting treatment.

    Your pneumonia symptoms and quality of life will be evaluated during this period.

  4. Step 4

    Extended follow-up - Day 15-30

    Additional monitoring continues until day 30.

    Your recovery status will be evaluated again at the end of this period.

    Any side effects from the treatment will be documented.

  5. Step 5

    Final assessment

    The effectiveness of the treatment will be evaluated based on your clinical recovery.

    Samples may be taken to check for antibiotic resistance.

    The impact of antibiotics on respiratory and gut bacteria will be assessed.

Who can join the trial?

13 criteria

  • Must be 18 years or older
  • Must have at least 2 of these signs of pneumonia:
    • Fever (temperature above 38°C/100.4°F)
    • Difficulty breathing (dyspnea)
    • Cough
    • Coughing up infected mucus (purulent sputum)
    • Crackling sounds in lungs when breathing (crackles)
    • Signs of infection on chest X-ray or CT scan
    • Must need antibiotics for respiratory infection as determined by doctor
    • Must have infection only in respiratory system (lungs), not in other parts of body
    • Must have internet access with WiFi at home
    • Must have valid health insurance
    • Must be able to take medications by mouth
    • Must provide written consent to participate in the study

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Patients with severe pneumonia requiring hospitalization (pneumonia is a lung infection)
  • Patients who have hospital-acquired pneumonia (infection developed during hospital stay)
  • Those with known immunodeficiency (weakened immune system)
  • Patients with severe underlying conditions that affect breathing
  • Those currently taking medications that suppress the immune system
  • Pregnant or breastfeeding women
  • Patients who have taken antibiotics in the past 7 days
  • Those with known allergies to the study medications
  • Patients who cannot follow study procedures or attend follow-up visits
  • Those participating in other clinical trials
  • Patients with serious mental health conditions that may affect their ability to participate
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Investigated drugs

Based on the provided trial data, I cannot list specific medications as the source information does not explicitly mention any medications or therapies. The trial appears to study antibiotic treatment duration for community-acquired pneumonia (CAP), but specific antibiotics are not named in the provided data. The study focuses on comparing different durations of antibiotic treatment rather than specific medications: - One approach involves stopping antibiotics based on patient's clinical response - The other approach involves conventional predetermined duration decided by the physician Without more specific information about which antibiotics are used in the trial, I cannot provide detailed descriptions of individual medications.

What is already known about the treatment

Based on the provided clinical trial data, I cannot create specific medication descriptions as no medications are explicitly mentioned in the source data. The trial appears to study antibiotic treatment duration for Community Acquired Pneumonia (CAP), but specific medications are not listed. If you would like me to provide medication descriptions, please provide the specific names of the antibiotics used in the trial. I will then create detailed descriptions following the requested format: Medication Name – description in a single paragraph.

Investigated diseases

Community Acquired Pneumonia (CAP) - An infection of the lungs that develops outside of hospitals or healthcare facilities. The condition occurs when viruses, bacteria, or other microorganisms enter the lungs and cause inflammation in the air sacs. This inflammation leads to the air sacs filling with fluid or pus, causing symptoms such as cough, fever, difficulty breathing, and chest pain. The infection typically develops over several days, with symptoms ranging from mild to severe. CAP primarily affects the lower respiratory tract and can occur in otherwise healthy people during their regular daily activities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516097-30-00Protocol codeP160929JEstimated enrolment500 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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