Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427076
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2007-01-24
Brief Title:
Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Treatment With Cotrimoxazole vs Vancomycin for Infections Caused by Methicillin-resistant Staphylococcus Aureus Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-09
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:
Methicillin-resistant Staphylococcus aureus SA is a major pathogen causing mainly health-care associated infections and lately also community acquired infections Few treatment choices exist to treat these infections The currently recommended antibiotics for these infections are glycopeptides vancomycin or teicoplanin Glycopeptide treatment hs several disadvantages It is a last resort antibiotic family that should be reserved for the future Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to both agents treatment can only be given intravenously and use of vancomycin has led to the development of SA strains with partial or complete resistance to vancomycin Cotrimoxazole is an old antibiotic active against most strains of MRSA depending on local epidemiology
Study hypothesis The purpose of this study is to show that cotrimoxazole is as effective as treatment with vancomycin for invasive MRSA infections
We plan a randomized controlled trial comparing treatment with cotrimoxazole vs vancomycin for invasive MRSA infections The primary efficacy outcome we will assess will be Improvement or cure with or without antibiotic modifications defined as survival at 7 days post randomization with resolution of fever 38 for two consecutive days and resolution of hypotension 90 systolic without need for vasopressor support and physicians assessment that the primary infection was improved or cured The primary safety outcome will be all-cause 30-day survival
Study hypothesis The purpose of this study is to show that cotrimoxazole is as effective as treatment with vancomycin for invasive MRSA infections
We plan a randomized controlled trial comparing treatment with cotrimoxazole vs vancomycin for invasive MRSA infections The primary efficacy outcome we will assess will be Improvement or cure with or without antibiotic modifications defined as survival at 7 days post randomization with resolution of fever 38 for two consecutive days and resolution of hypotension 90 systolic without need for vasopressor support and physicians assessment that the primary infection was improved or cured The primary safety outcome will be all-cause 30-day survival
Detailed Description:
Staphylococcus aureus SA is a major pathogen causing community-acquired and health-care associated infections In hospitals SA infections are associated with a significant burden in-hospital mortality during the last 15 years following SA bacteremia in Beilinson hospital was 38 and did not decrease in recent years Resistance to beta-lactams is widely prevalent in hospitals 57 of all SA isolates causing bacteremia at our center The drug of choice currently recommended for these infections is a glycopeptide vancomycin or teicoplanin
Cotrimoxazole trimethoprim-sulfamethoxazole is a relatively old drug commonly used for urinary tract infections Invitro it is active against SA including methicillin-resistance Staphylococcus aureus MRSA strains and its activity against SA is bactericidal Trimethoprim alone is bactericidal against SA while sulphamethoxazole alone is relatively inactive and their combination is synergistic both in-vitro and invivo The prevalence of cotrimoxazole-susceptible SA varies locally At our center 97 of SA strains causing bacteremia in 2004 were susceptible to cotrimoxazole Community-acquired MRSA prevalent in the United States as a cause for severe skin and soft tissue infections has not been described in Israel
Several reasons exist to search for antibiotics other than vancomycin for MRSA infections Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to both agents It is the last resort antibiotic for MRSA infections out of the currently recommended bactericidal antibiotics for invasive infections Use of vancomycin has led to the development of SA strains with partial or complete resistance to vancomycin VISA and VRSA respectively Vancomycin use is associated with the appearance of vancomycin-resistant enterococcus VRE species Nosocomial infections with VISA and VRE are difficult to treat and may spread rapidly in the hospital 10 Finally vancomycin cannot be administered orally
Limited evidence supports the efficacy of cotrimoxazole for MRSA infections with paucity of data for high-burden invasive infections Cotrimoxazole is probably inferior to vancomycin for methicillin-susceptible SA thus we may infer indirectly its inferiority to methicillin and drugs alike for MRSA infections Cotrimoxazole may be less effective than glycopeptides and oxacillin for left-sided endocarditis No evidence exists to support the use of cotrimoxazole empirically for the treatment of suspected SA infections in the hospital
We plan an open label single-center pragmatic randomized controlled trial to compare cotrimoxazole to vancomycin We will include patients with documented or highly suspected MRSA infections according to pre-defined risk factors We chose to target this patient population to assess the efficacy of cotrimoxazole both empirically and for documented infections
Cotrimoxazole trimethoprim-sulfamethoxazole is a relatively old drug commonly used for urinary tract infections Invitro it is active against SA including methicillin-resistance Staphylococcus aureus MRSA strains and its activity against SA is bactericidal Trimethoprim alone is bactericidal against SA while sulphamethoxazole alone is relatively inactive and their combination is synergistic both in-vitro and invivo The prevalence of cotrimoxazole-susceptible SA varies locally At our center 97 of SA strains causing bacteremia in 2004 were susceptible to cotrimoxazole Community-acquired MRSA prevalent in the United States as a cause for severe skin and soft tissue infections has not been described in Israel
Several reasons exist to search for antibiotics other than vancomycin for MRSA infections Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to both agents It is the last resort antibiotic for MRSA infections out of the currently recommended bactericidal antibiotics for invasive infections Use of vancomycin has led to the development of SA strains with partial or complete resistance to vancomycin VISA and VRSA respectively Vancomycin use is associated with the appearance of vancomycin-resistant enterococcus VRE species Nosocomial infections with VISA and VRE are difficult to treat and may spread rapidly in the hospital 10 Finally vancomycin cannot be administered orally
Limited evidence supports the efficacy of cotrimoxazole for MRSA infections with paucity of data for high-burden invasive infections Cotrimoxazole is probably inferior to vancomycin for methicillin-susceptible SA thus we may infer indirectly its inferiority to methicillin and drugs alike for MRSA infections Cotrimoxazole may be less effective than glycopeptides and oxacillin for left-sided endocarditis No evidence exists to support the use of cotrimoxazole empirically for the treatment of suspected SA infections in the hospital
We plan an open label single-center pragmatic randomized controlled trial to compare cotrimoxazole to vancomycin We will include patients with documented or highly suspected MRSA infections according to pre-defined risk factors We chose to target this patient population to assess the efficacy of cotrimoxazole both empirically and for documented infections
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