Gram-positive Bacterial InfectionsNCT00501150
Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections
A study testing linezolid in people with Gram-positive Bacterial Infections and Staphylococcal Infections, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Gram-positive Bacterial Infections, Staphylococcal Infections
- What is being tested?
- linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2005to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prescribed five or more days glycopeptide
- Fulfil IV-oral switch criteria (see below) with likelihood of discharge within next 48 hours.
Who cannot join
- Renal dialysis out patients
- Suspected or proven left sided endocarditis/osteomyelitis/prosthetic infection where the prosthesis cannot be removed
- 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).
- Age < 16 years
- Pregnant or lactating female.
- Other contraindication to linezolid
- Clinically unlikely to be discharged within study period or at end of antibiotic therapy.
Trial locations and contacts
1 site in 1 country.
About this 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
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
- 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
- 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.
Read the 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
- Being tested
- linezolid
- Keywords
- linezolid, vancomycin, glycopeptides, methicillin resistant staphylococcus aureus, resistant gram positive infections
- Medical subject headings
- Gram-Positive Bacterial Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linezolidDrug
Linezolid is an antimicrobial with activity against MRSA that can be given orally.
| Study group | Role | What they receive |
|---|---|---|
| Patients who fulfilled the study criteria | Experimental | IV to oral switch inclusion criteria used
1. Clinical status
* Temperature less than 38°C for 24 hours
* White cell count normalising
* No unexplained tachycardia (Heart rate less than 100 beats per minute)
* Sensitivity received (if microbiology positive)
2. Oral absorption
* Patient tolerates oral fluids
* No medical problems leading to reduced oral absorption (e.g. vomiting, diarrhoea, and gastrointestinal surgery)
* No surgical operation scheduled within next 36 hours
IV to oral switch exclusion criteria used
1. Continuing sepsis
* Temperature less than 36°C or more than 38°C
* White cell count less than 4 × 109/L or more than 12 × 109/L
* Unexplained tachycardia (Heart rate greater than 100 beats per minute in last 12 hours)
2. Oral route compromised
* Vomiting or severe diarrhoea
* Other ongoing or potential absorption problem Receives: Drug: linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the percentage of patients currently prescribed IV glycopeptides who could be discharged earlier if an oral agent was used
Measured: Period between IV oral switch and discharge, at least 24 hours
Secondary outcomes (3)
To estimate the number of inpatient days that could be saved
Measured: Period between IV oral switch and discharge, at least 24 hours
To identify the groups of patients most likely to be suitable for earlier discharge if an oral agent was used
Measured: Period between IV oral switch and discharge, at least 24 hours
To identify the additional number of days of IV antibiotic treatment that could be prevented by using an oral agent in hospitalised patients
Measured: Period between IV oral switch and discharge, at least 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startSep 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-positive Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Hammersmith Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Kathleen B Bamford, MB BCh BAO, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501150
- Sponsor's protocol ID
- BAMK1021
- Other IDs
- 05/q0406/106
- Status last verified
- Oct 2023
- First submitted
- 12 Jul 2007
- Last updated
- 26 Oct 2023
- Results posted
- No
Publications
Desai M, Franklin BD, Holmes AH, Trust S, Richards M, Jacklin A, Bamford KB. A new approach to treatment of resistant gram-positive infections: potential impact of targeted IV to oral switch on length of stay. BMC Infect Dis. 2006 Jun 8;6:94. doi: 10.1186/1471-2334-6-94.
PubMed 16762061
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00501150
- Acronym / sponsor ID
- BAMK1021
- Keywords
- linezolid, vancomycin, glycopeptides, methicillin resistant staphylococcus aureus, resistant gram positive infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Hammersmith Hospitals NHS Trust
- Study start
- Sep 2005 (actual)
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who fulfilled the study criteria | Experimental | Drug: linezolidIV to oral switch inclusion criteria used 1. Clinical status * Temperature less than 38°C for 24 hours * White cell count normalising * No unexplained tachycardia (Heart rate less than 100 beats per minute) * Sensitivity received (if microbiology positive) 2. Oral absorption * Patient tolerates oral fluids * No medical problems leading to reduced oral absorption (e.g. vomiting, diarrhoea, and gastrointestinal surgery) * No surgical operation scheduled within next 36 hours IV to oral switch exclusion criteria used 1. Continuing sepsis * Temperature less than 36°C or more than 38°C * White cell count less than 4 × 109/L or more than 12 × 109/L * Unexplained tachycardia (Heart rate greater than 100 beats per minute in last 12 hours) 2. Oral route compromised * Vomiting or severe diarrhoea * Other ongoing or potential absorption problem |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Prescribed five or more days glycopeptide
- Fulfil IV-oral switch criteria (see below) with likelihood of discharge within next 48 hours.
Key exclusion criteria (7 listed)
- Renal dialysis out patients
- Suspected or proven left sided endocarditis/osteomyelitis/prosthetic infection where the prosthesis cannot be removed
- 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).
- Age < 16 years
- Pregnant or lactating female.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| linezolidLinezolid is an antimicrobial with activity against MRSA that can be given orally. | Drug | Patients who fulfilled the study criteria |
Primary outcome
To identify the percentage of patients currently prescribed IV glycopeptides who could be discharged earlier if an oral agent was used
Time frame: Period between IV oral switch and discharge, at least 24 hours
3 secondary outcomes
To estimate the number of inpatient days that could be saved
Time frame: Period between IV oral switch and discharge, at least 24 hours
To identify the groups of patients most likely to be suitable for earlier discharge if an oral agent was used
Time frame: Period between IV oral switch and discharge, at least 24 hours
To identify the additional number of days of IV antibiotic treatment that could be prevented by using an oral agent in hospitalised patients
Time frame: Period between IV oral switch and discharge, at least 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Results publication: PubMed 16762061Desai M, Franklin BD, Holmes AH, Trust S, Richards M, Jacklin A, Bamford KB. A new approach to treatment of resistant gram-positive infections: potential impact of targeted IV to oral switch on length of stay. BMC Infect Dis. 2006 Jun 8;6:94. doi: 10.1186/1471-2334-6-94.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen B Bamford, MB BCh BAO principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing linezolid in people with Gram-positive Bacterial Infections and Staphylococcal Infections, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the percentage of patients currently prescribed IV glycopeptides who could be discharged earlier if an oral agent was used (time frame: Period between IV oral switch and discharge, at least 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.