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Randomized, double-blind trial of antibiotic exit site cream for prevention of exit site infection in peritoneal
Judith Bernardini1, Filitsa Bender, Tracey Florio
1Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
Abstract:
Infection is the Achilles heel of peritoneal dialysis. Exit site mupirocin prevents Staphylococcus aureus peritoneal dialysis (PD) infections but does not reduce Pseudomonas aeruginosa or other Gram-negative infections, which are associated with considerable morbidity and sometimes death. Patients from three centers (53% incident to PD and 47% prevalent) were randomized in a double-blinded manner to daily mupirocin or gentamicin cream to the catheter exit site. Infections were tracked prospectively by organism and expressed as episodes per dialysis-year at risk. A total of 133 patients were randomized, 67 to gentamicin and 66 to mupirocin cream. Catheter infection rates were 0.23/yr with gentamicin cream versus 0.54/yr with mupirocin (P = 0.005). Time to first catheter infection was longer using gentamicin (P = 0.03). There were no P. aeruginosa catheter infections using gentamicin compared with 0.11/yr using mupirocin (P < 0.003). S. aureus exit site infections were infrequent in both groups (0.06 and 0.08/yr; P = 0.44). Peritonitis rates were 0.34/yr versus 0.52/yr (P = 0.03), with a striking decrease in Gram-negative peritonitis (0.02/yr versus 0.15/yr; P = 0.003) using gentamicin compared with mupirocin cream, respectively. Gentamicin use was a significant predictor of lower peritonitis rates (relative risk, 0.52; 95% confidence interval, 0.29 to 0.93; P < 0.03), controlling for center and incident versus prevalent patients. Gentamicin cream applied daily to the peritoneal catheter exit site reduced P. aeruginosa and other Gram-negative catheter infections and reduced peritonitis by 35%, particularly Gram-negative organisms. Gentamicin cream was as effective as mupirocin in preventing S. aureus infections. Daily gentamicin cream at the exit site should be the prophylaxis of choice for PD patients.
Insights
Daily gentamicin cream at the exit site significantly reduces Gram-negative infections and peritonitis in peritoneal dialysis (PD) patients. This topical antibiotic is more effective than mupirocin for preventing serious PD-related infections.
Area of Science:
- Nephrology
- Infectious Diseases
- Clinical Trials
Background:
- Peritoneal dialysis (PD) is susceptible to infections, particularly Gram-negative bacteria, which cause significant morbidity and mortality.
- Mupirocin prophylaxis at the exit site is effective against Staphylococcus aureus but not Gram-negative infections in PD patients.
- Alternative prophylactic strategies are needed to reduce Gram-negative exit site and peritonitis infections in PD.
Purpose of the Study:
- To compare the efficacy of daily topical gentamicin versus mupirocin cream for preventing exit site infections (ESIs) and peritonitis in PD patients.
- To evaluate the impact of gentamicin prophylaxis on specific pathogens, including Pseudomonas aeruginosa and other Gram-negative bacteria.
Main Methods:
- A double-blind, randomized trial involving 133 PD patients across three centers.
- Participants were assigned to receive either daily mupirocin or gentamicin cream applied to the catheter exit site.
- Infections were prospectively tracked, and rates were expressed as episodes per dialysis-year at risk.
Main Results:
- Gentamicin cream significantly reduced overall catheter infection rates (0.23/yr vs. 0.54/yr, P = 0.005) and time to first infection (P = 0.03).
- No Pseudomonas aeruginosa catheter infections occurred with gentamicin, compared to 0.11/yr with mupirocin (P < 0.003).
- Gentamicin reduced peritonitis rates by 35% (0.34/yr vs. 0.52/yr, P = 0.03), particularly Gram-negative peritonitis (0.02/yr vs. 0.15/yr, P = 0.003).
Conclusions:
- Daily topical gentamicin cream at the exit site is superior to mupirocin for preventing Gram-negative PD-related infections, including P. aeruginosa.
- Gentamicin prophylaxis significantly decreases peritonitis rates in PD patients, especially those caused by Gram-negative organisms.
- Topical gentamicin should be considered the preferred prophylactic agent for PD patients to reduce exit site and peritonitis infections.
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