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

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.

Conditions

• Coronary Heart Disease
• Chlamydophila Pneumoniae Infections

Interventions

DRUG

Doxycycline Capsule

doxycycline capsule

DRUG

Azithromycin Capsule

azithromycin capsule

DRUG

Rifabutin Oral Capsule

rifabutin capsule

DRUG

Placebo oral capsule

Placebo oral capsule identical in size and form to doxycycline

DRUG

Placebo Oral Tablet

Placebo oral capsule identical in size and form to azithromcyin

DRUG

Placebo oral capsule

Placebo oral capsule identical in size and form to rifabutin

Sponsors & Collaborators

• Centre for Digestive Diseases, Australia

  collaborator OTHER

• Cadrock Pty. Ltd.

  lead OTHER

Principal Investigators

• Thomas Borody · Centre for Digestive Diseases

• John French · Liverpool Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-04

Primary Completion

2020-11-30

Completion

2020-11-30

Countries

• Australia

Study Locations