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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501150
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : May 28, 2015
Hammersmith Hospitals NHS Trust
Information provided by:
Imperial College London

Brief Summary:

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 or disease Intervention/treatment Phase
Gram-positive Bacterial Infections Staphylococcal Infections Drug: linezolid Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

Primary Outcome Measures :
  1. 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 :
  1. to identify groups of patients treated with a glycopeptide who could be discharged on an oral agent.
  2. to apply iv-oral switch criteria as piloted in a previous study
  3. To apply discharge on oral criteria as piloted in a previous study
  4. To compare the resource utilisation between intravenous treatment in hospital and discharge on oral treatment
  5. to evaluate patient preference for "iv-inpatient" vs "discharge on oralwith follow-up" treatments.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501150

United Kingdom
Imperial College London
London, United Kingdom, w12 0nn
Sponsors and Collaborators
Imperial College London
Hammersmith Hospitals NHS Trust
Principal Investigator: Kathleen B Bamford, MB BCh BAO Imperial College London Identifier: NCT00501150     History of Changes
Other Study ID Numbers: BAMK1021
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: November 2005

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

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