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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

  • Azithromycin

    is an oral antibiotic that works against many bacteria that cause lung infections. In this trial it is given to patients with suspected community‑acquired pneumonia to see how well the infection improves when the treatment is stopped based on the patient’s own symptoms and device measurements.

  • Doxycycline

    is an oral antibiotic that fights a broad range of bacteria. It is combined with a medication that helps loosen mucus in the lungs. In the study it is used to treat suspected pneumonia, and the researchers are testing whether stopping the drug early, guided by the patient’s clinical response, works as well as a longer, fixed course.

  • Pristinamycin

    is an oral antibiotic that targets bacteria commonly found in respiratory infections. Participants with suspected pneumonia receive this drug, and the trial evaluates if ending treatment early, based on how the patient feels and device data, is as effective as the usual longer treatment.

  • Amoxicillin and beta‑lactamase inhibitor

    (a combination of amoxicillin with clavulanic acid) is an oral antibiotic that kills bacteria and protects the amoxicillin from being broken down by certain enzymes. In the trial it is given to people with suspected pneumonia, and the study looks at whether stopping the medication early, according to the patient’s response, is safe and works as well as a standard longer course.

  • Amoxicillin

    is an oral antibiotic that treats many types of bacterial lung infections. In this study it is used for patients with suspected community‑acquired pneumonia, and the researchers are testing if a shorter, response‑guided treatment period is just as effective as the usual longer regimen.

  • Clarithromycin

    is an oral antibiotic that fights bacteria that cause respiratory infections. In the trial it is administered to participants with suspected pneumonia, and the goal is to see whether stopping the drug early, based on the patient’s clinical signs and device readings, provides similar outcomes to a longer predetermined treatment.

What is already known about the treatment

  • Azithromycin

    This medication is taken by mouth as a 500 mg tablet. It is an approved and widely studied antibiotic that is commonly used to treat community‑acquired pneumonia and other respiratory infections. It works by stopping bacteria from making the proteins they need to grow. It belongs to the macrolide class of antibiotics.

  • Doxycycline (with Ambroxol)

    The drug is given orally as a tablet containing 200 mg doxycycline together with ambroxol, a substance that helps clear mucus. Both components are approved and used for a range of infections, including pneumonia, and ambroxol also eases breathing by thinning secretions. Doxycycline blocks bacterial protein production, while ambroxol acts as a mucolytic. Doxycycline is a tetracycline antibiotic and ambroxol is a mucolytic agent.

  • Pristinamycin

    This antibiotic is taken by mouth as a 3 g oral powder that is dissolved in water. It is an established drug in several countries and is used for infections that do not respond to other antibiotics, such as severe pneumonia. It stops bacteria from building proteins by binding to their ribosomes. Pristinamycin is classified as a streptogramin antibiotic.

  • Amoxicillin and Clavulanic Acid

    The combination is taken orally as a 3 g tablet that contains amoxicillin and clavulanic acid. It is a standard, widely approved treatment for community‑acquired pneumonia and many other bacterial infections. Amoxicillin kills bacteria by breaking their cell walls, while clavulanic acid blocks enzymes that some bacteria produce to resist amoxicillin. This product is a penicillin antibiotic paired with a beta‑lactamase inhibitor.

  • Amoxicillin

    This drug is taken by mouth as a 3 g tablet. It is a common, approved antibiotic used for pneumonia and many other infections. It works by breaking the bacterial cell wall, which leads to bacterial death. Amoxicillin belongs to the penicillin class of antibiotics.

  • Clarithromycin

    The medication is administered orally as a 1 g tablet. It is an approved treatment for community‑acquired pneumonia and other respiratory infections. Clarithromycin stops bacteria from making essential proteins, which halts their growth. It is classified as a macrolide antibiotic.

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 21 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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