Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections

This study has been completed.
Sponsor:
Collaborator:
Hammersmith Hospitals NHS Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00501150
First received: July 12, 2007
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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

  1. To identify those patients who could potentially be discharged on an oral agent from those being treated with a glycopeptide, thus helping target this approach most effectively
  2. To evaluate the cost involved and compare this with the costs that would have taken place if use of an oral agent and discharge had not occurred.

Condition Intervention
Gram-Positive Bacterial Infections
Staphylococcal Infections
Drug: linezolid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • to evaluate the effectiveness of intravenous(iv) to oral switch in achieving early discharge in patients with infections caused by resistant gram positive bacteria.

Secondary Outcome Measures:
  • to identify groups of patients treated with a glycopeptide who could be discharged on an oral agent.
  • to apply iv-oral switch criteria as piloted in a previous study
  • To apply discharge on oral criteria as piloted in a previous study
  • To compare the resource utilisation between intravenous treatment in hospital and discharge on oral treatment
  • to evaluate patient preference for "iv-inpatient" vs "discharge on oralwith follow-up" treatments.

Estimated Enrollment: 100
Study Start Date: September 2005
Study Completion Date: June 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Prescribed five or more days glycopeptide
  2. Fulfil IV-oral switch criteria (see below) with likelihood of discharge within next 48 hours.

Exclusion Criteria:

  1. Renal dialysis out patients
  2. Suspected or proven left sided endocarditis/osteomyelitis/prosthetic infection where the prosthesis cannot be removed
  3. Per-protocol prescribing in haematology (i.e. where teicoplanin is prescribed in response to failure of fever resolution in neutropenic patients without microbiological or clinical evidence of gram positive infection).
  4. Age < 16 years
  5. Pregnant or lactating female.
  6. Other contraindication to linezolid
  7. Clinically unlikely to be discharged within study period or at end of antibiotic therapy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00501150

Locations
United Kingdom
Imperial College London
London, United Kingdom, w12 0nn
Sponsors and Collaborators
Imperial College London
Hammersmith Hospitals NHS Trust
Investigators
Principal Investigator: Kathleen B Bamford, MB BCh BAO Imperial College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00501150     History of Changes
Other Study ID Numbers: BAMK1021, 05/q0406/106
Study First Received: July 12, 2007
Last Updated: July 12, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
linezolid
vancomycin
glycopeptides
methicillin resistant staphylococcus aureus
resistant gram positive infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Staphylococcal Infections
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014