RecruitingPhase 2ACTRN12618000260224

Anti-chlamydophila antibiotic combination therapy in the treatment of patients with Coronary Heart Disease

Prospective Study to evaluate the safety and measure efficacy of anti-Chlamydophila antibiotic combination (ACAC) therapy in the treatment of patients with Coronary Heart Disease (CHD)


Sponsor

Centre for Digestive Diseases

Enrollment

60 participants

Start Date

Apr 12, 2018

Study Type

Interventional

Conditions

Summary

The purpose of the study is to see whether the antibiotic combination of 100mg doxycycline, 500mg azithromycin and 300mg rifabutin is a safe and effective treatment for coronary artery disease which has not responded to "standard" treatment. Coronary artery disease is the process of plaque build up within the walls of the arteries responsible for the supplying the heart with oxygen and nutrients. Plaque is usually made up of fatty deposits, minerals and various amounts of tissue and white cells which eventually narrows the artery, reducing blood flow to the heart. The resulting damage and build up of fat results in inflammation of the arterial wall and eventually the arteries narrow. The researchers involved in this study consider that a pathogen called Chlamydophila pneumonia, which can live inside cells, may cause this inflammation of the arterial wall. The purpose of this study is to see if treatment with this antibiotic combination in patients with CHD is safe and effective in reducing disease severity measured at coronary angiography and improving quality-of-life. Approximately 60 patients will be involved in this trial. The treatment period is 90 days, with a further 90 day follow-up period.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of three antibiotics — doxycycline, azithromycin, and rifabutin — can safely treat coronary artery disease (blocked heart arteries) that has not responded well to standard treatment. The researchers think that a bacteria called Chlamydophila pneumoniae, which can live inside the artery walls, may be causing inflammation that leads to blockages. Participants will take the antibiotic combination or a placebo for 90 days and be monitored for safety, quality of life, and changes in their heart arteries. You may be eligible if: - You are aged 18 to 80 years - You are male, or a female who cannot become pregnant (due to hysterectomy, tubal ligation, or being at least one year post-menopause) - You have documented recent acute coronary syndrome or evidence of heart muscle ischaemia (reduced blood flow to the heart) - You have been identified as suitable for a staged coronary procedure (PCI) You may NOT be eligible if: - You are a woman who could become pregnant - You have significant blood, liver, kidney, neurological, or psychiatric disease - You are allergic to any of the antibiotics used - You drink heavily (more than 60g alcohol/day for men, 40g/day for women) - You have been in another drug trial in the past 4 weeks Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Anti-Chlamydaphila antibiotic combination: Doxycycline, Azithromycin & Rifabutin Dose: 50mg Doxycycline, 250mg Azithromycin & 150mg Rifabutin (3 separate capsules) daily (days 1 to 7), 50mg Doxycyc

Anti-Chlamydaphila antibiotic combination: Doxycycline, Azithromycin & Rifabutin Dose: 50mg Doxycycline, 250mg Azithromycin & 150mg Rifabutin (3 separate capsules) daily (days 1 to 7), 50mg Doxycycline, 250mg Azithromycin & 150mg Rifabutin (3 separate capsules) twice daily (days 8 to 90). Duration: 90 days Mode: oral capsules


Locations(2)

Liverpool Hospital - Liverpool

NSW, Australia

Centre for Digestive Diseases - Five Dock

NSW, Australia

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ACTRN12618000260224


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