Study Comparing Clarithromycin and Azithromycin for Treating Mycobacterium Avium Complex Lung Infections in Adults

1 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of lung infections caused by the Mycobacterium avium complex, a type of bacteria that can lead to serious respiratory issues. The study compares two medications: clarithromycin and azithromycin. Both are antibiotics commonly used to treat bacterial infections. The purpose of the study is to determine if azithromycin is as effective as clarithromycin in treating these lung infections.

Participants in the study will receive either clarithromycin or azithromycin over a period of time, and their progress will be monitored to see how well the bacteria in their lungs respond to the treatment. The main goal is to see if the bacteria are cleared from the lungs after six months of treatment. The study will also look at other factors, such as any side effects from the medications and improvements in lung health as seen on scans.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. This includes checking for any digestive issues or liver problems, as well as assessing overall health improvements. The study aims to provide more options for doctors in choosing the best treatment for patients with Mycobacterium avium complex lung infections.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to Mycobacterium avium complex (MAC) lung disease. This includes respiratory symptoms and specific findings on a chest scan, as well as positive cultures for MAC.

2 randomization and treatment assignment

Participants are randomly assigned to receive either clarithromycin or azithromycin as part of their treatment regimen. This is to compare the effectiveness of these two medications in treating MAC lung disease.

3 medication administration

The treatment involves taking medications orally. The medications include Rifampicin (300 mg capsule), Clarithromycin (500 mg modified-release tablet), Ethambutol hydrochloride (500 mg film-coated tablet), and Azithromycin (250 mg film-coated tablet).

The specific dosage and frequency of each medication are determined by the study protocol and are administered over a period of six months.

4 monitoring and assessments

Throughout the study, regular monitoring is conducted to assess the treatment’s effectiveness and safety. This includes checking for negative sputum conversion, which means the absence of MAC in sputum samples after six months.

Additional assessments include monitoring for any digestive issues, liver function, and clinical and radiological improvements.

5 follow-up evaluations

Follow-up evaluations occur at three and twelve months to check for sputum conversion and overall health outcomes. This includes checking for any new symptoms or changes in existing conditions.

6 completion of the study

The study concludes with a final evaluation of the treatment’s effectiveness and safety. The primary endpoint is the six-month negative sputum conversion rate, while secondary endpoints include safety assessments and clinical improvements.

Who Can Join the Study?

  • The patient must be 18 years old or older.
  • The patient must meet the ATS/IDSA 2007 criteria for a type of lung infection caused by bacteria that are not the usual tuberculosis bacteria. This includes:
    • Clinical criteria: The patient must have breathing problems and a specific type of lung damage seen on a special chest scan called a high-resolution computed tomography (CT) scan. This damage can look like small nodules or cavities in the lungs.
    • Microbiological criteria: The patient must have at least two positive test results for the bacteria called Mycobacterium avium complex (MAC) from two different samples of mucus from the lungs taken on different days.
    • Alternatively, a positive test for MAC from a sample taken during a procedure called bronchoalveolar lavage or bronchoscopic aspiration is acceptable.
    • Alternatively, a lung tissue sample taken during a procedure called transbronchial biopsy or surgical lung biopsy must show signs of infection by mycobacteria, such as a specific type of inflammation called a granuloma or a positive result on a special stain test, along with a positive culture for MAC.
    • Alternatively, a biopsy showing signs of mycobacterial infection and one or more positive cultures for MAC from mucus samples is acceptable.
  • Other possible causes of the symptoms must be ruled out using CT scans, a procedure called bronchoscopy, and other tests. If common bacteria are found, the symptoms and lung damage must continue even after proper antibiotic treatment to suggest a MAC infection.
  • If there are signs of another infection called Aspergillus fumigatus along with signs of MAC infection, the patient may have both infections.
  • Both male and female patients can participate.
  • The study does not include vulnerable populations.

Who Cannot Join the Study?

  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have a history of allergic reactions to azithromycin or clarithromycin, which are the drugs being studied.
  • Patients who are currently participating in another clinical trial or have participated in one within the last 30 days.
  • Patients with severe liver disease, as this can affect how the body processes the medication.
  • Patients with a history of heart rhythm problems, as the study drugs can affect heart rhythm.
  • Patients who are pregnant or breastfeeding, as the effects of the study drugs on unborn babies or infants are not fully known.
  • Patients with a known infection with a different type of bacteria that requires treatment with other antibiotics.
  • Patients who have a condition that, in the opinion of the study doctor, would make participation unsafe or affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Groupe Hospitalier Du Sud Ile De France Melun France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Hopital D’Instruction Des Armees Percy Clamart France
Centre Hospitalier De Cannes Simone Veil Cannes France
Centre Hospitalier De Roubaix Roubaix France
Clinique de l’Europe Amiens France
Centre Hospitalier Pays de Morlaix Morlaix France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Metropole Savoie Chambery France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Saint Joseph Marseille France
Hopital NOVO Pontoise France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier De Perigueux Perigueux France
Centre Hospitalier Intercommunal Compiegne Noyon Compiegne France
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Clerbn Hulraphgusj Uheuvoxweldzs Rkbvk Reims France
Iddeskyq Mvfaerzqqz Mxfqegmdbu Paris France
Cioteu Hsagxxtlsvw Dx Cdjrpw Chauny France
Cmfbzb Hbskpvkcxpm Dunybezxnmzjcyztk Abbeville France
Ckp dgetbxextfqudc Epagny Metz Tessy France
Cwukpb Hxgzfpjnvwh Es Urlrlubzktbtm Db Lnymibr Limoges France
Cnuoxm Hhgzgrtwnsc Upyampohcaptx Dv Djdzm Dijon France
Aeligcqdkh Pftkpfcx Htneqiuh Di Mchoyngvz Marseille France
Beydppma Uyomnpssbq Hblstfvc Czpqdp Besançon France
Ctgvqk Hwathgutuea Rxfgweim Uygrkdafxwagq Dz Tfqyx Tours France
Ciru Di Nbhpy Vandoeuvre Les Nancy France
Ctgirc Hjylebgddyk Rwttzrby Dyalcbvgbrvlib Angers France
Iedmawxh di Chgvmfzcwljy Hhddqlbaory Uevakrrgfoqlz da Scbtl Evlgwmc (axxhjoj Saint Priest En Jarez France
Cumgkw Hraawmfkuru Udsrhueeqnuma ds lu Giexpymrcc Pointe A Pitre France
Hgpeqyyz Uznqxqscqqqlyw Spzgrmpqwk &micqrz Hzkdtvk dq Hrlpmvhfrly STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
05.02.2018

Trial locations

Clarithromycin is an antibiotic used in this study to treat lung infections caused by Mycobacterium avium complex (MAC). It works by stopping the growth of bacteria, helping to clear the infection from the lungs.

Azithromycin is another antibiotic being tested in this trial for its effectiveness in treating MAC lung infections. Like clarithromycin, it helps to stop the growth of bacteria, aiming to clear the infection from the lungs.

Mycobacterium avium complex lung disease – This is a chronic lung infection caused by a group of bacteria known as Mycobacterium avium complex (MAC). It primarily affects individuals with pre-existing lung conditions or weakened immune systems. The disease progresses slowly, often starting with symptoms like a persistent cough, fatigue, and weight loss. Over time, it can lead to more severe respiratory issues, including shortness of breath and chest pain. The bacteria can cause inflammation and damage to lung tissue, leading to the formation of nodules or cavities. The progression of the disease can vary, with some individuals experiencing stable symptoms while others may see a gradual worsening of their condition.

Trial ID:
2024-518578-15-00
Protocol code:
PI2017_843_0010
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Zongertinib with cisplatin or carboplatin and pemetrexed, with or without pembrolizumab, for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations

    Recruiting

    1 1 1
    Investigated diseases:
    France Germany Spain
  • Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Germany Hungary Poland Portugal +1