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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Maison de santé pluriprofessionnelle universitaire Jacques Prévert	Montigny le Bretonneux	France

Other Sites

Site Name	City	Country
Crosraf mhbizvy Iphy Pmjba Rfbrnwq Lflzol	Paris	France
Clnlamr mxcqold Ijrl Phczt Oljxy	Paris	France
Cnvdmdd Cdezz Nipvfvtzgi	Versailles	France
Mt Mbdujy Majtfrjt &oayzmj Slgpodmeeqo	Saint-Cloud	France
Irix Sqxdh	Paris	France
Csloryk mineotp Ifut Pdsuq Izbgtm	Paris	France
Mvwruh Mrpsgway Cglmrl Vqxl	Paris	France
Cfaiduv macfnxd Iumq Lmdr Biyzmphxo	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	29.11.2024

Trial locations

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.

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 ID:

2024-516097-30-00

Protocol code:

P160929J

NCT ID:

NCT04166110

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?