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Sponsors and Collaborators: |
Imperial College London Hammersmith Hospitals NHS Trust |
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Information provided by: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00501150 |
The main purpose of this study is to find out whether changing the hospital policy to allow switch from glycopeptide antibiotics (given by intravenous drip), to an equally effective oral antibiotic (linezolid) will enable patients who are otherwise well enough to be discharged from hospital sooner.
The secondary objectives are
Condition | Intervention |
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Gram-Positive Bacterial Infections Staphylococcal Infections |
Drug: linezolid |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Prospective Implementation of an IV-Oral Switch Policy to Treat Proven or Suspected Infections Due to Resistant Gram Positive Bacteria in a London Hospital Trust |
Estimated Enrollment: | 100 |
Study Start Date: | September 2005 |
Study Completion Date: | June 2007 |
The treatment of resistant gram positive infections remains problematic, with glycopeptides remaining the mainstay of current management. Unfortunately these can only be administered by the IV route, with no useful activity when given orally for these infections. Thus while oral flucloxacillin or ampicillin are used as follow up to IV treatment in the management of infections caused by antibiotic sensitive Staphylococcus aureus or enterococcal respectively, in the case of antibiotic resistant infections the whole course of antibiotics is usually given by the IV route. To some extent this is because there is insufficient evidence to support routine use of other oral agents and means that patients with antibiotic resistant infections stay in hospital longer than those with antibiotic sensitive infections.
Linezolid is a relatively newly available antibiotic that has been shown to be as, and in some settings more effective than glycopeptides in the treatment of resistant gram positive infections including MRSA. Unfortunately Linezolid is significantly more expensive than other currently available agents making it important to evaluate the cost benefit aspects of its use in comparison to similarly effective agents.
Switching from IV to a suitable oral alternative in the management of resistant gram positive infection could potentially result in significant saving in the duration of IV therapy and would allow patients to be discharged earlier. This would provide a significant cost benefit which in the face of Linezolids equal if not superior efficacy would justify more widespread use in order to allow suitable patients to be treated at home.
The rationale behind this study is to determine the level at which this can be implemented in an NHS teaching hospital Trust. To do this we will identify patients who could potentially benefit from early discharge on oral therapy, implement this where possible and compare the actual effect on LOS with the potential identified in the earlier cohort of patients.
We propose to prospectively assess the economic and clinical impact of switching from IV glycopeptides to oral Linezolid and implementing home treatment on oral therapy policy over an 18 month period in HHT hospitals Two senior infection specialists(a Medical Microbiologist, K Bamford and an Infectious Disease physician, A Holmes) will independently review each patient together with the study pharmacist and decide if the individual is suitable for switch to an oral agent and/or discharge using standardised criteria for decision making. Patients will be studied to assess the number of attributable bed days, line use days, ward pharmacist interventions (to trigger monitoring and adjust dose) and investigations and medical complications that accrue due to IV administration following glycopeptide prescription. The various costs to the Trust which are saved when the IV glycopeptide is switched to a suitable oral alternative and early discharge implemented will be calculated
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Imperial College London | |
London, United Kingdom, w12 0nn |
Principal Investigator: | Kathleen B Bamford, MB BCh BAO | Imperial College London |
Study ID Numbers: | BAMK1021, 05/q0406/106 |
Study First Received: | July 12, 2007 |
Last Updated: | July 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00501150 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
linezolid vancomycin glycopeptides methicillin resistant staphylococcus aureus resistant gram positive infections |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections |
Methicillin Vancomycin Linezolid |
Protein Synthesis Inhibitors Anti-Infective Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |