Study on Customized Antibiotic Treatment Duration for Hospitalized Patients with Community-Acquired Pneumonia Using Cefotaxime and Drug Combination

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What is this study about?

This clinical trial focuses on patients with community-acquired pneumonia, a type of lung infection that is acquired outside of a hospital setting. The study aims to evaluate a new approach to antibiotic treatment duration, comparing it to the standard treatment duration. The antibiotics being studied include amoxicillin, amoxicillin and beta-lactamase inhibitor, pristinamycin, levofloxacin, ceftriaxone, and cefotaxime. These medications are commonly used to treat bacterial infections and will be administered either orally or through injections.

Participants in the study will receive one of the antibiotics mentioned above, or a placebo, for a period of up to 10 days. The study will monitor patients to determine when it is safe to stop the antibiotic treatment based on specific health criteria, such as body temperature and heart rate. The goal is to see if stopping antibiotics when these criteria are met is as effective as the traditional longer treatment duration.

The trial will track the patients’ recovery over a period of 30 days, checking for the persistence of stability criteria, the need for additional antibiotic treatment, and overall health outcomes. The study will also assess the impact of the treatment on the patients’ quality of life and any side effects experienced during the trial period. This research aims to improve the management of community-acquired pneumonia by potentially reducing the duration of antibiotic use without compromising patient recovery.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide informed consent, confirming your understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking for symptoms of community-acquired pneumonia and ensuring you meet the study’s inclusion criteria.

3 treatment phase

You will receive antibiotic treatment for a minimum of 48 hours. The specific medication and dosage will be determined based on your condition and may include options such as amoxicillin, pristinamycin, cefotaxime, levofloxacin, or ceftriaxone.

The route of administration will vary: some medications are taken orally, while others may be given through an injection or infusion.

4 monitoring stability

Your health will be monitored to assess stability. Stability is defined by criteria such as normal body temperature, heart rate, blood pressure, and oxygen levels.

If stability is achieved after at least 48 hours of treatment, the duration of antibiotic use may be adjusted.

5 follow-up assessments

Follow-up assessments will occur at various intervals, including Day 15 and Day 30 after treatment initiation. These assessments will evaluate the rate of cure and monitor any symptoms or side effects.

Your quality of life and any changes in pneumonia symptoms will also be assessed during these follow-ups.

6 completion of the study

Upon completion of the study, a final evaluation will be conducted to ensure all criteria have been met and to document any outcomes or adverse events.

The study aims to determine the effectiveness of customized antibiotic treatment duration for patients with moderately severe community-acquired pneumonia.

Who Can Join the Study?

Must be an adult (18 years or older).
Must have a negative viral respiratory test. If the test is positive, there must be proof of a bacterial infection.
Must be expected to need antibiotics for at least one more day if not in the experimental group.
Must be hospitalized for suspected community-acquired pneumonia, shown by at least two of these symptoms:
- Fever (temperature over 38°C) or low body temperature (below 36°C)
- Shortness of breath (dyspnea)
- Cough
- Producing thick mucus (purulent sputum)
- Crackling sounds in the lungs
Must have new lung changes visible on a chest X-ray or CT scan.
Must have been treated with antibiotics for at least 48 hours and no more than 7 days, following French guidelines, and still be on antibiotics.
Must show signs of clinical improvement in the last 24 hours, including:
- Normal body temperature (≤ 37.8°C)
- Heart rate under 100 beats per minute
- Breathing rate under 24 breaths per minute
- Oxygen levels in the blood at or above 92%
- Blood pressure at or above 90 mmHg
No other infections besides the respiratory one.
Must have health insurance or government medical aid.
Must have given informed consent to participate.
Must understand oral and written French, or have a relative who can help with communication and study documents.

Who Cannot Join the Study?

Patients who have a different type of infection other than community-acquired pneumonia cannot participate. Community-acquired pneumonia is a lung infection that you get outside of a hospital setting.
Patients who are under 18 years old or over 65 years old are not eligible to join the study.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have a weakened immune system, which means their body has a harder time fighting infections, are not allowed to participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients who have a history of severe allergic reactions to antibiotics cannot join the study.
Patients with severe liver or kidney disease are not allowed to participate.
Patients who have a mental health condition that makes it difficult to understand or follow the study instructions cannot take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Hospital Foch	Suresnes	France
Hopital Beaujon	Clichy	France
Acrxyhcitd Pvyrizdl Htcfpzkp Dk Pxomm	Paris	France
Roahdhoyckmjseuy Hrferdwv	Garches	France
Hufwomt Hpuhr Mgvvbi &fulouj 1 rmi Gkhmbjr Eokyuc	Creteil	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.12.2023

Trial locations

Investigated drugs:

Experimental Strategy on Antibiotic Treatment: This is a new approach being tested in the trial. It involves giving antibiotics to patients with community-acquired pneumonia and stopping the treatment when the patient shows signs of stability, but only after they have been on the medication for at least 48 hours. The goal is to see if this method is as effective as the usual practice of giving antibiotics for a set number of days. This strategy is being tested to potentially reduce the duration of antibiotic use while still effectively treating the infection.

Community-acquired pneumonia – Community-acquired pneumonia is an infection of the lungs that occurs in individuals who have not recently been hospitalized. It is typically caused by bacteria, viruses, or fungi that are inhaled into the lungs. The disease begins with symptoms such as cough, fever, chills, and difficulty breathing. As it progresses, patients may experience chest pain, fatigue, and confusion, especially in older adults. The infection leads to inflammation and fluid accumulation in the air sacs of the lungs, impairing oxygen exchange. Recovery involves the resolution of symptoms and the clearing of the infection from the lungs.

Trial ID:

2023-504208-27-00

Protocol code:

APHP220814

NCT ID:

NCT05903352

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Customized Antibiotic Treatment Duration for Hospitalized Patients with Community-Acquired Pneumonia Using Cefotaxime and Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?