Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol

Surapon Nochaiwong, Chidchanok Ruengorn, Kajohnsak Noppakun, Setthapon Panyathong, Phongsak Dandecha, Manish M Sood, Chalermpong Saenjum, Ratanaporn Awiphan, Sasithorn Sirilun, Pajaree Mongkhon, Wilaiwan Chongruksut, Kednapa Thavorn, Thai Renal Outcomes Research (THOR) Investigators, Surapon Nochaiwong, Chidchanok Ruengorn, Kajohnsak Noppakun, Setthapon Panyathong, Phongsak Dandecha, Manish M Sood, Chalermpong Saenjum, Ratanaporn Awiphan, Sasithorn Sirilun, Pajaree Mongkhon, Wilaiwan Chongruksut, Kednapa Thavorn, Thai Renal Outcomes Research (THOR) Investigators

Abstract

Background: Current international guidelines recommend the use of a daily topical exit-site antimicrobial to prevent peritoneal dialysis (PD)-related infections. Although nonantibiotic-based therapies are appealing because they may limit antimicrobial resistance, no controlled trials have been conducted to compare topical antimicrobial agents with usual exit-site care for the prevention of PD-related infections among the Thai PD population. We propose a controlled three-arm trial to examine the efficacy and safety of a daily chlorhexidine gluconate-impregnated patch versus mupirocin ointment versus usual exit-site care with normal saline for the prevention of PD-related infections.

Methods/designs: This study is a randomized, double-blind, multicenter, active-controlled, clinical trial. Adult patients aged 18 years or older who have end-stage kidney disease and are undergoing PD will be enrolled at three PD Centers in Thailand. A total of 354 PD patients will be randomly assigned to either the 2% chlorhexidine gluconate-impregnated patch, mupirocin ointment, or usual exit-site care with normal saline dressing according to a computer-generated random allocation sequence. Participants will be followed until discontinuation of PD or completion of 24 months. The primary study outcomes are time to first PD-related infection (exit-site/tunnel infection or peritonitis) event and the overall difference in PD-related infection rates between study arms. Secondary study outcomes will include (i) the rate of infection-related catheter removal and PD technique failure, (ii) rate of nasal and exit-site Staphylococcus aureus colonization, (iii) healthcare costs, and (iv) skin reactions and adverse events. We plan to conduct a cost-utility analysis alongside the trial from the perspectives of patients and society. A Markov simulation model will be used to estimate the total cost and health outcome in terms of quality-adjusted life years (QALYs) over a 20-year time horizon. An incremental cost-effectiveness ratio in Thai Baht and U.S. dollars per QALYs gained will be illustrated. A series of probabilistic sensitivity analyses will be conducted to assess the robustness of the cost-utility analysis findings.

Discussion: The results from this study will provide new clinical and cost-effectiveness evidence to support the best strategy for the prevention of PD-related infections among the Thai PD population.

Trial registration: ClinicalTrials.gov, NCT02547103. Registered on September 11, 2015.

Keywords: Chlorhexidine, Cost-utility, Infection, Mupirocin, Normal saline, Peritoneal dialysis, Prevention, Randomized controlled trial.

Conflict of interest statement

The authors declare that they have no competing interests. All the researchers involved performed this study in the context of their research.

Figures

Fig. 1
Fig. 1
Study flow of the COSMO-PD trial
Fig. 2
Fig. 2
A simplified Markov model structure of the COSMO-PD trial

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