Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart Disease

• Status: Terminated
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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 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 leads to inflammation of the arterial wall and eventually the arteries narrow. The researchers involved in this study consider that a pathogen called Chlamydophila pneumoniae, 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadrock Pty. Ltd.
• Collaborator: Centre for Digestive Diseases, Australia
• Treatments: Anti-Bacterial Agents; Azithromycin; Doxycycline; Rifabutin

Criteria

Inclusion Criteria:

1. Males and females (without childbearing potential as evidenced by hysterectomy, tubal ligation or at least one year post-menopause) aged 18 to 80 years inclusive.

2. Ability to provide written informed consent to participate in the study.

3. Subjects with documented recent acute coronary syndrome (ACS) or evidence of myocardial ischemia.

4. Subjects who have a culprit lesion suitable for PCI, and a non-critical lesion in another vessel suitable for staged PCI with an FFR of <0.80, for subjects undergoing diagnostic angiography and FFR without ad hoc PCI.

5. No serious co-morbidities, which might interfere with the subject's ability to enter the study.

6. Able to communicate effectively with the study team and to comply with the protocol.

Exclusion Criteria:

1. Females that are of child bearing potential

2. Subjects without a non-culprit lesion considered appropriate to plan a staged PCI.

3. Clinically significant haematologic, hepatic, metabolic, renal, rheumatologic, anaphylactic reactions, neurological or psychiatric disease.

4. Clinical evidence of any other disease, which might interfere with the subject's ability to enter the trial.

5. Concomitant administration of medications that may interfere with treatment as assessed by the Investigator, including allergy to any component of the therapy.

6. Concomitant administration of any medication prohibited for use during this study (e.g. colchicine)

7. Male subjects consuming greater than 60g alcohol per day, or female subjects consuming greater than 40g alcohol per day.

8. Evidence of any recent history of, or current recreational drug abuse.

9. Serious adverse reaction or hypersensitivity to therapeutic drugs.

10. Unable and to comply with the study requirements.

11. Subjects who have been involved in an experimental drug protocol within the past four weeks.

If a subject becomes pregnant during the course of the study, they will be immediately withdrawn and treated in the way least likely to harm both subject and foetus.