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

NCT00501150 | Completed

• 2 other identifiers: BAMK102105/q0406/106
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Gram-positive Bacterial Infections; Staphylococcal Infections

Keywords

linezolid; vancomycin; glycopeptides; methicillin resistant staphylococcus aureus; resistant gram positive infections

Outcome Measures

Primary Outcomes (1)

• To identify the percentage of patients currently prescribed IV glycopeptides who could be discharged earlier if an oral agent was used

  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

  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

  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

  Period between IV oral switch and discharge, at least 24 hours

Study Arms (1)

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

Drug: linezolid

Interventions

linezolid DRUG

Linezolid is an antimicrobial with activity against MRSA that can be given orally.

Patients who fulfilled the study criteria

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Hammersmith Hospitals NHS Trust: collaborator

Study Sites (1)

Imperial College London

London, w12 0nn, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 16762061 RESULT

MeSH Terms

Conditions

Gram-Positive Bacterial Infections; Staphylococcal Infections

Interventions

Linezolid

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kathleen B Bamford, MB BCh BAO

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 13, 2007
• Study Start: September 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

GB (1)