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CompletedNCT00304811Updated Sep 28, 2009

Vancomycin vs. Vancomycin Plus Gentamycin in Treatment of MRSA Infection

A Phase 4 interventional study of Vancomycin and Vancomycin plus Gentamicin in Staphylococcus Aureus, sponsored by Michael E. DeBakey VA Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2009-09-28.

Sponsored by Michael E. DeBakey VA Medical Center · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

The purpose of this study is to compare the outcome of treatment for bacteremic MRSA infection with vancomycin alone, vancomycin plus gentamicin, vancomycin plus rifampin, and vancomycin plus gentamicin and rifampin.

Read the detailed description

Treatment of bacteremic infection (infection associated with positive blood cultures) due to Staphylococcus aureus has become increasingly problematic as a result of the increasing prevalence of strains that are resistant to beta-lactam antibiotics (so-called methicillin-resistant Staphylococcus aureus, MRSA). About 70% of hospital-related strains of S. aureus are MRSA, and, in the past 4 years, the incidence of MRSA in community-acquired infection has risen to about 50%; these data are quite representative of what is being seen elsewhere in the United States and other parts of the world.

Bacteremic MRSA infections are highly problematic for at least two reasons: (1)they are serious, with substantial morbidity and about a 25% rate of mortality in middle-aged adults, the principal patients in our system; and (2)available antibiotic therapy is suboptimal.

In the pre-MRSA era (before 1982 in the United States), treatment of bacteremic S. aureus infection with a beta-lactam antibiotic such as nafcillin produced a uniform microbiological cure (Musher DM, McKenzie SO: Infections due to Staphylococcus aureus. Medicine 56:383-409, 1977). This means that, in the absence of an untreated focus of infection that required surgical removal (such as a myocardial abscess), antibiotics rapidly sterilized the blood stream. This does not mean that no one died; deaths from complications of infection remained common. But, at autopsy, there was generally no evidence for active infection. Extensive literature examined the question of whether gentamicin should be added to nafcillin to treat this kind of disease (reviewed critically in DM, Verner EF: Treatment of Infections due to Staphylococcus aureus. IN The Staphylococci, Ed. by J Jeljascewicz, Gustave Fischer Verlag, Stuttgart, New York, pp.407-419, 1986). Gentamicin produced a synergistic bactericidal effect agains S. aureus in vitro and in animal models. In humans, the addition of gentamicin was associated with more rapid sterilization of the blood stream, but prolonged gentamicin therapy was also associated with nephrotoxicity.

In contrast, in the MRSA era, treatment with vancomycin is associated with persistence of bacteremia (positive blood cultures) and death from active infection. We have recently participated in a prospective observational study that documented the association between vancomycin treatment, persistently positive blood cultures, and persistence of active infection during treatment of S. aureus bacteremia with vancomycin (Chang F-Y, McDonald BB, Peacock, Jr. JE, Musher DM, et al. Staphylococcus aureus bacteremia: recurrence and the impact of antibiotic treatment in a prospective multicenter study. Medicine 82:333-339, 2003).

There appears to be a very close correlation between the outcome of treatment for serious S. aureus infection and the bactericidal activity of the treating antibiotic in vitro using conventional techniques (Musher DM, Verner EF: Treatment of infections due to Staphylococcus aureus. IN The Staphylococci, Ed. by J Jeljascewicz, Gustave Fischer Verlag, Stuttgart, New York, pp.407-419, 1986). We recently showed that adding low concentrations of gentamicin to vancomycin led to substantial synergistic bactericidal activity against MRSA (Shelburne SA, Musher DM, Hulten K, Ceasar H, Lu MY, Bhaila I, Hamill RJ. In-vitro killing of community-associated methicillin-resistant Staphylococcus aureus with drug combinations. Antimicrob Agents Chemother 48:4016-9, 2004).

Based in part on the analogy of nafcillin for treating methicillin-susceptible S. aureus infection, and in part of in vitro studies such as ours (cited above), some physicians regularly add gentamicin to vancomycin for treating MRSA infection. Others, without even the in vitro support, add rifampin either instead of gentamicin or together with gentamicin. There are no clinical studies to support or to refute any of these clinically motivated usages.

Thus, at present, about one-third of patients with MRSA bacteremia at VAMC are treated with vacomycin plus gentamicin, and two-thirds receive vancomycin alone; some in each group receive rifampin. The decisionto add gentamicin is made a haphazard fashion. Our proposal is, once MRSA has been identified in acceptable regimens by stratifying patients prospectively to vancomycin alone or vancomycin plus gentamicin, and further stratifying each of those groups to be with or without rifampin.

02

Conditions studied

  • Staphylococcus Aureus

Keywords

  • MRSA
  • Methicillin Resistant Staphylococcus aureus
03

In context

Staphylococcal Infections

273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.

This study's planned enrollment of 160 is above the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

Michael E. DeBakey VA Medical Center is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with MRSA in a blood culture processed as standard of care at the VAMC
  • Patients or next of kin willing to sign consent to be randomized by social security number to one of the treatments.

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
160 participants (estimated)

Interventions

  • DrugVancomycin
  • DrugVancomycin plus Gentamicin
  • DrugVancomycin plus Rifampin
  • DrugVancomycin plus Gentamicin plus Rifampin
06

What researchers measure

Primary outcomes

  1. Time to defervescence (24 hours of temperature <100 degrees F)

  2. Return of WBC to normal (<10,500)

  3. negative blood cultures

  4. discharge

07

Study locations

2 sites
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Michael E. DeBakey Veterans Affairs Medical Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00304811
Lead sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Baylor College of Medicine
First posted
Mar 20, 2006
Start date
Jan 2006
Primary completion
Jan 2007
Completion
Jan 2007
Last update
Sep 28, 2009

Study contacts

Daniel M Musher, MD
principal investigator · Baylor College of Medicine, Houston VA Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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