Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT00501150
Study type Interventional
Source Imperial College London
Contact
Status Completed
Phase N/A
Start date September 2005
Completion date June 2007

See also
  Status Clinical Trial Phase
Completed NCT01447407 - Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine Phase 1
Recruiting NCT00518076 - Staphylococcus Aureus Carriers Students Nursing Oxacillin Resistant N/A
Completed NCT01324440 - Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002) Phase 1
Completed NCT00071214 - Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis Phase 3
Completed NCT00063089 - Safety and Behavior of S. Aureus Immune Globulin Intravenous(Human), [Altastaph] in Patients With S. Aureus Bacteremia and Continuing Fever Phase 1/Phase 2
Completed NCT00175370 - Vancomycin Study: Treatment of Catheter Related Bloodstream Infection Caused by Coagulase Negative Staphylococcus N/A
Recruiting NCT03456544 - Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
Completed NCT02557568 - Evaluation of an Algorithm for Identifying Persistent Nasal Staphylococcus Aureus Carriage in a Cohort of Healthy Volunteers and Patients Regularly Monitored at the CHU of Saint-Etienne N/A
Terminated NCT01196169 - Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty Phase 4
Completed NCT02971657 - Bacterial Phenotype of Staphylococcus Aureus Has no Effect on Patients` Clinical Outcome in Orthopedic Device Related Bone Infections N/A
Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT02640937 - Biofilm Formation in Staphylococcus Epidermidis Associated Implant Infections N/A
Completed NCT00303069 - V710 First-In-Man (FIM) Study (V710-001) Phase 1
Completed NCT00156377 - Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections Phase 4
Completed NCT00631566 - Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons N/A
Completed NCT00113191 - Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants N/A
Completed NCT02782078 - Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections N/A
Completed NCT00859677 - Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
Completed NCT00211900 - Evaluation of Manufacturing Lot of StaphVAX Phase 3
Completed NCT02492958 - SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults Phase 2