Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501150
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2007-07-12
Brief Title:
Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 specialistsa 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 andor 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
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 specialistsa 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05q0406106 | None | None | None |