Study on Reducing Antibiotic Use in Severe COPD Exacerbation with Amoxicillin, Cefotaxime, and Ciprofloxacin for Patients on Mechanical Ventilation or Oxygen Therapy

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What is this study about?

This clinical trial focuses on patients experiencing severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD), a condition that affects the lungs and makes breathing difficult. During these exacerbations, patients may require mechanical ventilation or high-flow oxygen therapy. The study aims to evaluate a new approach to reduce the duration of antibiotic treatment in these patients. The antibiotics being studied include Amoxicillin, Cefotaxime, Ciprofloxacin, Spiramycin, and a combination of Piperacillin and Beta-Lactamase Inhibitor. These medications are commonly used to treat bacterial infections and will be administered in various forms, such as injections or tablets.

The purpose of the study is to assess whether a personalized diagnostic and therapeutic strategy can effectively reduce the use of antibiotics compared to the usual treatment methods. This approach involves using advanced techniques like MULTIplex PCR and measuring procalcitonin levels, which are indicators of bacterial infection, along with observing the appearance of sputum, a substance produced in the lungs. The study will be conducted in a controlled, randomized manner, meaning participants will be randomly assigned to different treatment groups to ensure unbiased results.

Participants in the study will receive treatment for up to seven days, and their progress will be monitored over a period of 28 days. The main goal is to determine the number of days patients can live without antibiotics by the end of this period. Secondary outcomes include the number of days patients require antibiotics, the incidence of hospital-acquired infections, and the overall duration of hospital stays. The study will also track the occurrence of any additional COPD exacerbations and assess patients’ quality of life using the COPD Assessment Test (CAT) at 90 days. The trial is expected to conclude in early 2025.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, COPD diagnosis, and current health status.

Consent is required from the patient or a relative.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s condition, including the severity of COPD exacerbation and respiratory failure.

This assessment helps determine the appropriate treatment strategy.

3 treatment allocation

Patients are randomly assigned to either a personalized diagnostic and therapeutic strategy or a usual care strategy.

The goal is to evaluate the effectiveness of reducing antibiotic use during severe COPD exacerbation.

4 medication administration

Medications such as amoxicillin, cefotaxime, ciprofloxacin, and spiramycin may be administered based on the assigned treatment strategy.

Routes of administration include oral, intravenous, and injection, depending on the specific medication and patient needs.

5 monitoring and follow-up

Patients are monitored for the number of days alive without antibiotics by day 28.

Secondary outcomes include the incidence of pneumonia, duration of ICU stay, and overall hospital stay.

6 final assessment

A final assessment is conducted to evaluate the patient’s recovery and any additional COPD exacerbations.

The COPD Assessment Test (CAT) may be administered to assess the patient’s condition at day 90.

Who Can Join the Study?

Must be 18 years old or older.
Must have COPD (Chronic Obstructive Pulmonary Disease) that has been confirmed after smoking, according to guidelines from 2020, regardless of the stage (I-IV).
Must be experiencing an acute exacerbation of COPD, which means a sudden worsening of symptoms, leading to acute respiratory failure. This requires admission to the Intensive Care Unit (ICU) and the use of mechanical ventilation (either invasive, non-invasive, or high-flow nasal oxygen therapy with a high oxygen concentration).
Must provide consent to participate, which can be given by the patient, a relative, or in an emergency situation.
Must be affiliated with a social security scheme.

Who Cannot Join the Study?

Patients who are not experiencing an episode of worsening symptoms of Chronic Obstructive Pulmonary Disease (COPD) that requires the use of a machine to help them breathe, either through a tube or mask, or with high-flow oxygen through the nose.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Hopital Tenon	Paris	France
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Centre Hospital Region Metz Thionville	Metz	France
Hopital Bichat – Claude Bernard	Paris	France
Clpgxi Hwexhhkluku Uoalsfqibnrre Rzimm	Reims	France
Gprqn Hhuqnpp df lhsvwizvxlz Fzqnlzdiat &sbpasv Sfdo dr Medgn lt Vcwsss	Jossigny	France
Hokuyql Snkca Adhbtkz	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	19.07.2021

Trial locations

Investigated drugs:

Antibiotic Therapy
This therapy involves the use of antibiotics to treat infections that may occur during severe exacerbations of chronic obstructive pulmonary disease (COPD). The goal is to reduce the duration of antibiotic use by employing a personalized diagnostic and therapeutic strategy.

MULTIplex PCR
This is a diagnostic test that can detect multiple pathogens from a single sample. It helps in identifying the specific cause of an infection, allowing for a more targeted antibiotic treatment during severe COPD exacerbations.

Procalcitonin Testing
Procalcitonin is a substance produced by the body in response to bacterial infections. Testing its levels can help determine whether an infection is bacterial, which can guide the decision to start or stop antibiotic therapy.

Sputum Appearance Assessment
This involves examining the color and consistency of sputum (mucus from the lungs) to help determine the presence and type of infection. This assessment is part of the strategy to decide on the necessity and duration of antibiotic treatment during COPD exacerbations.

Investigated diseases:

Chronic obstructive pulmonary disease

Exacerbation of Chronic Obstructive Pulmonary Disease (EA-COPD) – This condition refers to a sudden worsening of symptoms in individuals with chronic obstructive pulmonary disease (COPD). It is characterized by increased breathlessness, coughing, and production of sputum. During an exacerbation, patients may require additional medical support, such as mechanical ventilation or oxygen therapy. The progression of EA-COPD can lead to more frequent hospitalizations and a decline in lung function over time. It is often triggered by infections or environmental pollutants. Managing exacerbations is crucial to maintaining quality of life and preventing further lung damage.

Trial ID:

2024-511896-13-00

Protocol code:

APHP210085

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Reducing Antibiotic Use in Severe COPD Exacerbation with Amoxicillin, Cefotaxime, and Ciprofloxacin for Patients on Mechanical Ventilation or Oxygen Therapy

What is this study about?

Who Can Join the Study?

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