Impact of antibiotic administration route on GIT microbiome
Research type
Research Study
Full title
Impact of antibiotic administration route on the diversity and metabolism of the gastrointestinal tract (GIT) microbiome of patients undergoing treatment for serious bacterial infections, including Outpatient Parenteral Antibiotic Therapy (OPAT): a feasibility study.
IRAS ID
193836
Contact name
Gavin Barlow
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals NHS Trust
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
The ongoing emergence of antibacterial resistance, particularly in Gram negative bacteria, is currently of major global concern. The gastrointestinal tract (GIT) microbiome is known to be an important ‘amplifier’ of resistance. The ‘health’ of this microbiome is related to the risk of Clostridium difficile infection (CDI) and has been increasingly associated with non-infection illnesses, such as diabetes and obesity. Outpatient Parenteral Antibiotic Therapy (OPAT) is increasingly employed as a strategy in the UK to treat serious infections that require parenteral (intravenous; IV) antibiotic therapy in patients who are well enough to be treated as an outpatient. OPAT is now embedded as a key step in Start Smart and then Focus, the antimicrobial stewardship guidance/strategy for England, but little is known about the impact of OPAT, which often exploits once-daily broad-spectrum antibiotics (e.g. ceftriaxone, ertapenem) for prolonged periods, on the GIT microbiome, although Clostridium difficile infection is considered uncommon. This study will assess the feasibility of measuring the differential impact of antibiotic administration route (IV versus oral) on the diversity of the human GIT microbiome over time in patients (N≈6-10) being treated for infections at Hull and East Yorkshire Hospitals NHS Trust including via a well established OPAT service. Breath and faecal samples will be collected from participants prescribed a range of antibiotic regimens (i.e. broad/narrow-spectrum, oral/IV) before, during and after antibiotic therapy with the microbial diversity of the samples analysed at the University of York by molecular techniques. Inter- and intra-patient comparisons will be made in order to compare the impact of different antibiotic regimens, including route of administration and spectrum of activity. The project will not influence how patients are managed with the only additional requirement being the collection of weekly faecal and breath samples. This project will form the main component of Dr. Farah Shahi's NIHR-funded academic clinical fellowship.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0345
Date of REC Opinion
22 Sep 2016
REC opinion
Further Information Favourable Opinion