A study of antibiotic use and its effects on a marker of infection in chronic heart failure
- Conditions
- Chronic heart failure.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-004745-40-GB
- Lead Sponsor
- Hull and East Yorkshire Hospitals NHS Trust.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
• Ability to give, legally valid, written informed consent
• Clinical diagnosis of heart failure
• NT-proBNP plasma concentration >400ng/L
• Procalcitonin plasma concentration >50 pg/ml
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
•Age <18 years
•Inability to understand or read English.
•Women of child bearing potential
•Antibiotic use in the prior 6 weeks
•Endocarditis
•Any known cancer
•Previous major adverse effect to azithromycin or metronidazole (eg:- allergy, severe diarrhoea, need for hospital treatment of adverse effect)
•Unwilling to avoid alcohol for one week (requested in all arms of the study)
•Surgery of any kind in previous 6 weeks (includes device implantation)
•Heart transplant recipient
•Recipient of a left ventricular assist device
•Inability to follow instructions or comply with follow-up procedures
•Porphyria (use of macrolides and metronidazole is contra indicated )
•Contra-indications to one week’s treatment with azithromycin, metronidazole (if not already listed in the exclusion criteria)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method