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Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.

ABSTRACT: BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia.Enrollment in this prospective, multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to March 2012. Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days. Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution. Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months.At the 3-month follow-up, the percentage reductions in BK viral load were 70.3% and 69.1% in the levofloxacin group and the placebo group, respectively (P=0.93). The percentage reductions in BK viral load were also equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus 90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period.A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression.

SUBMITTER: Lee BT

PROVIDER: S-EPMC3944757 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.

Lee Belinda T BT Gabardi Steven S Grafals Monica M Hofmann R Michael RM Akalin Enver E Aljanabi Aws A Mandelbrot Didier A DA Adey Deborah B DB Heher Eliot E Fan Pang-Yen PY Conte Sarah S Dyer-Ward Christine C Chandraker Anil A

Clinical journal of the American Society of Nephrology : CJASN 20140130 3

<h4>Background and objectives</h4>BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia.<h4>Design, setting, ...[more]

PMID: 24482066

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Project description:BackgroundPersons with diabetes are at high risk of developing diabetic kidney disease (DKD), which is associated with high morbidity and mortality. Current drug therapies for DKD, such as angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), are not entirely satisfactory. This study aimed to evaluate the additional benefit and safety of the Chinese herbal granule Tangshen Formula (TSF) in treating DKD.MethodsThe study was designed as a six-center randomized, double-blind, placebo-controlled trial. From April 2007 through December 2009, 180 patients with DKD were enrolled. In addition to conventional treatment with ACEIs or ARBs, 122 participants were randomly assigned to receive TSF and 58 participants to receive placebo for 24 weeks. Primary outcome was urinary protein level, measured by urinary albumin excretion rate (UAER) for participants with microalbuminuria, 24-hour urinary protein (24h UP) for participants with macroalbuminuria. Secondary outcomes included renal function, serum lipids, quality of life, symptoms, and adverse events.FindingsAfter 24 weeks of treatment, no statistically significant difference in UAER (TSF -19.53??g/min compared with placebo -7.01??g/min, with a mean difference of -12.52??g/min; 95%CI, -68.67 to 43.63, P?=?0.696) was found between TSF and placebo groups. However, TSF displayed a statistically significant decrease in 24h UP (TSF-0.21?g compared with placebo 0.36?g, with a mean difference of -0.57g; 95%CI, -1.05 to -0.09, P?=?0.024). Estimated glomerular filtration rate (eGFR) was improved in both patients with microalbuminuria and macroalbuminuria, with a mean difference of 15.51?ml/min/1.73?m2 (95%CI, 3.71 to 27.31), 9.01?ml/min/1.73?m2 (95%CI, -0.10 to 18.13), respectively. Other secondary outcomes showed no statistically significant difference between groups or in the incidence of adverse events.ConclusionsBased on conventional treatments, TSF appears to provide additional benefits compared with placebo in decreasing proteinuria and improving eGFR in DKD patients with macroalbuminuria. Nevertheless, further study is needed to evaluate TSF treating patients with microalbuminuria.Trial registrationChinese Clinical Trial Registry ChiCTR-TRC-10000843.

Project description:(1) Background: Dental calculus works as a niche wherein pathogenic bacteria proliferate in the oral cavity. Previous studies revealed the anticalculus activity of pyrophosphates, however there was no clinical study that evaluated microbiome changes associated with calculus inhibition. Therefore, the aim of this randomized clinical trial was to evaluate the calculus inhibition of pyrophosphate-containing toothpaste and its effect on oral microbiome changes. (2) Methods: Eighty subjects with a calculus index ?2 on the lingual of the mandibular anterior tooth were randomly allocated to the test group that pyrophosphate-containing toothpaste was given to or the placebo control group. Full mouth debridement and standardized tooth brushing instruction were given before the allocation. Plaque index, gingival index, calculus index, probing depth, and bleeding on probing were measured at the baseline, and at 4, 8 and 12 weeks. Genomic DNA was extracted from the plaque samples collected at the baseline and at 12 weeks, and 16S ribosomal RNA gene amplicon sequencing was applied for microbiome analysis. (3) Results: None of the clinical parameters showed significant differences by visits or groups, except the plaque index of the test group, which reduced significantly between 4 and 12 weeks. A significant difference of microbiome between the baseline and 12 weeks was observed in the test group. Between baseline and 12 weeks, the proportion of Spirochetes decreased in the control group, and the proportions of Proteobacteria, Fusobacteria and Spirochetes in the phylum level and the proportions of Haemophilus, Fusobacterium and Capnocytophaga in the genus level decreased in the test group. In the test group, as plaque index decreased, Streptococcus increased, and Fusobacterium and Haemophilus parainfluenza decreased. (4) Conclusion: The use of pyrophosphate-containing toothpaste effectively inhibited the dysbiosis of the oral microbiome and the proliferation of pathogenic species in periodontal disease. Clinically, plaque formation in the pyrophosphate-containing toothpaste group was effectively decreased, however there was no significant change in calculus deposition.

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Dataset Information

Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.

Publications

Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.

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