Study on the Safety of Inhaled Teicoplanin for Treating Staphylococcus aureus Infections in Cystic Fibrosis Patients

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What is this study about?

This clinical trial is focused on studying the safety and tolerability of a medication called Teicoplanin for patients with cystic fibrosis who have persistent infections caused by a type of bacteria known as Staphylococcus aureus, including a resistant form called MRSA. Cystic fibrosis is a genetic condition that affects the lungs and digestive system, leading to severe respiratory and digestive problems. The study aims to see how well patients tolerate inhaled Teicoplanin, which is a treatment designed to help manage these bacterial infections.

Participants in the study will receive Teicoplanin through inhalation at a dose of 200 mg twice a day. The treatment will be given in two cycles, each lasting 28 days, with a 28-day break in between the cycles. The study will monitor the participants’ health and any side effects they may experience during and after the treatment cycles. The goal is to ensure that the medication is safe and to observe how it affects the bacterial infection in the lungs.

Throughout the study, various health checks will be conducted to assess lung function and the presence of the bacteria in the lungs. These checks will help determine if the treatment is effective in reducing the bacterial load and improving lung health. The study will also look at any changes in symptoms such as coughing, chest tightness, and breathing difficulties. The information gathered will contribute to understanding how well Teicoplanin works for treating these infections in cystic fibrosis patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of cystic fibrosis, and persistent Staphylococcus aureus infection.

Informed consent is required, ensuring understanding of the study’s nature and compliance with its requirements.

2 baseline assessment

Initial assessments are conducted to establish baseline measurements. These include lung function tests such as FEV1, which measures the amount of air you can forcefully exhale in one second.

Bacterial load in sputum is measured to determine the presence of Staphylococcus aureus.

3 first treatment cycle

The first treatment cycle involves administering teicoplanin at a dosage of 200 mg/3ml twice daily (BID) for 28 days.

The medication is inhaled, allowing it to reach the lungs directly.

4 first evaluation

After completing the first treatment cycle, evaluations are conducted to assess safety and tolerability.

Measurements include changes in lung function, oxygen saturation, and any side effects such as coughing or chest discomfort.

5 treatment-free period

A 28-day period without treatment follows the first evaluation. This allows for observation of any changes in health status without the influence of the medication.

6 second treatment cycle

The second treatment cycle mirrors the first, with teicoplanin administered at the same dosage and frequency for another 28 days.

7 second evaluation

Following the second treatment cycle, another set of evaluations is conducted.

These assessments focus on changes in bacterial load, lung function, and any persistent side effects.

8 follow-up period

A follow-up period is observed to monitor long-term effects and any changes in health status.

Final assessments are conducted to compare with baseline measurements and evaluate the overall impact of the treatment.

Who Can Join the Study?

Must be a male or female patient aged 12 years or older.
Must have a confirmed diagnosis of Cystic Fibrosis, which is a genetic condition affecting the lungs and digestive system.
Must have a persistent infection with Staphylococcus aureus, including MRSA (a type of bacteria that is resistant to some antibiotics). This means having at least three positive tests for this bacteria in the sputum (a mixture of saliva and mucus) within the last 24 months.
Must have a lung function test result, called FEV1 (Forced Expiratory Volume in 1 second), between 50% and 90% of what is predicted for a person of the same age, gender, height, and weight.
Must be able to understand the study and agree to follow the study’s rules and requirements.
Must have signed a written informed consent form to participate in the study. If under 18 years of age, a guardian must sign the consent form after understanding the benefits and risks.

Who Cannot Join the Study?

Patients who do not have cystic fibrosis with a persistent infection caused by Staphylococcus aureus, including a type called MRSA (a bacteria that is resistant to some antibiotics), cannot participate.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so those outside these groups are excluded.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of people.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may not be safe for them or their babies.
Patients who are taking certain medications that might interfere with the study drug cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	16.09.2024

Trial locations

Investigated drugs:

Teicoplanin

Teicoplanin is an antibiotic used in this study to treat infections caused by Staphylococcus aureus, including MRSA, in patients with cystic fibrosis. The medication is administered through inhalation, allowing it to directly target the lungs where the infection is present. The study aims to assess how safe and well-tolerated this treatment is for patients.

Investigated diseases:

Cystic fibrosis

Cystic Fibrosis Associated with Persistent Staphylococcus aureus Infection – Cystic fibrosis is a genetic disorder that affects the respiratory and digestive systems, leading to the production of thick, sticky mucus. This mucus can cause blockages and create an environment where bacteria like Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA), can thrive. Persistent infection with these bacteria can lead to chronic lung infections, causing inflammation and damage to lung tissue. Over time, this can result in decreased lung function and increased respiratory symptoms such as coughing and difficulty breathing. The condition requires ongoing management to control infections and maintain lung health.

Trial ID:

2024-517820-21-00

Protocol code:

CRCFC-TEICO.SA.2022

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of Inhaled Teicoplanin for Treating Staphylococcus aureus Infections in Cystic Fibrosis Patients

What is this study about?

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