Dataset Information

Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.

ABSTRACT:

Background

An increase in infections after transrectal prostate biopsy (PB), related to an increasing number of patients with ciprofloxacin-resistant rectal flora, necessitates the exploration of alternatives for the traditionally used empirical prophylaxis of ciprofloxacin. We compared infectious complication rates after transrectal PB using empirical ciprofloxacin prophylaxis versus culture-based prophylaxis.

Methods

In this nonblinded, randomized trial, between 4 April 2018 and 30 July 2021, we enrolled 1538 patients from 11 Dutch hospitals undergoing transrectal PB. After rectal swab collection, patients were randomized 1:1 to receive empirical prophylaxis with oral ciprofloxacin (control group [CG]) or culture-based prophylaxis (intervention group [IG]). Primary outcome was any infectious complication within 7 days after biopsy. Secondary outcomes were infectious complications within 30 days, and bacteremia and bacteriuria within 7 and 30 days postbiopsy. For primary outcome analysis, the χ2 test stratified for hospitals was used. Trial registration number: NCT03228108.

Results

Data from 1288 patients (83.7%) were available for analysis (CG, 652; IG, 636). Infection rates within 7 days postbiopsy were 4.3% (n = 28) (CG) and 2.5% (n = 16) (IG) (P value = .08; reduction: -1.8%; 95% confidence interval, -.004 to .040). Ciprofloxacin-resistant bacteria were detected in 15.2% (n = 1288). In the CG, the presence of ciprofloxacin-resistant rectal flora resulted in a 6.2-fold higher risk of early postbiopsy infection.

Conclusions

Our study supports the use of culture-based prophylaxis to reduce infectious complications after transrectal PB. Despite adequate prophylaxis, postbiopsy infections can still occur. Therefore, culture-based prophylaxis must be weighed against other strategies that could reduce postbiopsy infections. Clinical Trials Registration. NCT03228108.

SUBMITTER: Tops SCM

PROVIDER: S-EPMC10069853 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.

Tops Sofie C M SCM Kolwijck Eva E Koldewijn Evert L EL Somford Diederik M DM Delaere Filip J M FJM van Leeuwen Menno A MA Breeuwsma Anthonius J AJ de Vocht Thijn F TF Broos Hans J H P HJHP Schipper Rob A RA Steffens Martijn G MG Teerenstra Steven S Wegdam-Blans Marjolijn C A MCA de Brauwer Els E van den Bijllaardt Wouter W Leenders Alexander C A P ACAP Sedelaar J P Michiel JPM Wertheim Heiman F L HFL

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20230401 7

<h4>Background</h4>An increase in infections after transrectal prostate biopsy (PB), related to an increasing number of patients with ciprofloxacin-resistant rectal flora, necessitates the exploration of alternatives for the traditionally used empirical prophylaxis of ciprofloxacin. We compared infectious complication rates after transrectal PB using empirical ciprofloxacin prophylaxis versus culture-based prophylaxis.<h4>Methods</h4>In this nonblinded, randomized trial, between 4 April 2018 and ...[more]

PMID: 36419331

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Project description:BackgroundCulture-based antibiotic prophylaxis is a plausible strategy to reduce infections after transrectal prostate biopsy (PB) related to fluoroquinolone-resistant pathogens.ObjectiveTo assess the cost effectiveness of rectal culture-based prophylaxis compared with empirical ciprofloxacin prophylaxis.Design setting and participantsThe study was performed alongside a trial in 11 Dutch hospitals investigating the effectiveness of culture-based prophylaxis in transrectal PB between April 2018 and July 2021 (trial registration number: NCT03228108).InterventionPatients were 1:1 randomized for empirical ciprofloxacin prophylaxis (oral) or culture-based prophylaxis. Costs for both prophylactic strategies were determined for two scenarios: (1) all infectious complications within 7 d after biopsy and (2) culture-proven Gram-negative infections within 30 d after biopsy.Outcome measurements and statistical analysisDifferences in costs and effects (quality-adjusted life-years [QALYs]) were analyzed from a healthcare and societal perspective (including productivity losses, and travel and parking costs) using a bootstrap procedure presenting uncertainty surrounding the incremental cost-effectiveness ratio in a cost-effectiveness plane and acceptability curve.Results and limitationsFor the 7-d follow-up period, culture-based prophylaxis (n = 636) was €51.57 (95% confidence interval [CI] 6.52-96.63) more expensive from a healthcare perspective and €16.95 (95% CI -54.29 to 88.18) from a societal perspective than empirical ciprofloxacin prophylaxis (n = 652). Ciprofloxacin-resistant bacteria were detected in 15.4%. Extrapolating our data, from a healthcare perspective, 40% ciprofloxacin resistance would lead to equal cost for both strategies. Results were similar for the 30-d follow-up period. No significant differences in QALYs were observed.ConclusionsOur results should be interpreted in the context of local ciprofloxacin resistance rates. In our setting, from a healthcare perspective, culture-based prophylaxis was significantly more expensive than empirical ciprofloxacin prophylaxis. From a societal perspective, culture-based prophylaxis was somewhat more cost effective against the threshold value customary for the Netherlands (€80.000).Patient summaryCulture-based prophylaxis in transrectal prostate biopsy was not associated with reduced costs compared with empirical ciprofloxacin prophylaxis.

Project description:Background and Objectives: To assess the effects of fosfomycin compared with other antibiotics as a prophylaxis for urinary tract infections (UTIs) in men undergoing transrectal prostate biopsies. Materials and Methods: We searched multiple databases and trial registries without publication language or status restrictions until 4 January 2022. Parallel-group randomized controlled trials (RCTs) and non-randomized studies (NRS) were included. The primary outcomes were febrile UTI, afebrile UTI, and overall UTI. We used GRADE guidance to rate the certainty of evidence of RCTs and NRSs. The protocol was registered with PROSPERO (CRD42022302743). Results: We found data on five comparisons; however, this abstract focuses on the primary outcomes of the two most clinically relevant comparisons. Regarding fosfomycin versus fluoroquinolone, five RCTs and four NRSs with a one-month follow-up were included. Based on the RCT evidence, fosfomycin likely resulted in little to no difference in febrile UTIs compared with fluoroquinolone. This difference corresponded to four fewer febrile UTIs per 1000 patients. Fosfomycin likely resulted in little to no difference in afebrile UTIs compared with fluoroquinolone. This difference corresponded to 29 fewer afebrile UTIs per 1000 patients. Fosfomycin likely resulted in little to no difference in overall UTIs compared with fluoroquinolone. This difference corresponded to 35 fewer overall UTIs per 1000 patients. Regarding fosfomycin and fluoroquinolone combined versus fluoroquinolone, two NRSs with a one- to three-month follow-up were included. Based on the NRS evidence, fosfomycin and fluoroquinolone combined may result in little to no difference in febrile UTIs compared with fluoroquinolone. This difference corresponded to 16 fewer febrile UTIs per 1000 patients. Conclusions: Compared with fluoroquinolone, fosfomycin or fosfomycin and fluoroquinolone combined may have a similar prophylactic effect on UTIs after a transrectal prostate biopsy. Given the increasing fluoroquinolone resistance and its ease to use, fosfomycin may be a good option for antibiotic prophylaxis.

Project description:BackgroundWe evaluated the effectiveness of targeted antimicrobial prophylaxis in transrectal ultrasound guided prostate biopsy (TRUSP).MethodsA prospective, non-randomized cohort study was conducted. Rectal swab cultures plated on non-selective blood agar and on selective MacConkey agar supplemented with ciprofloxacin identified ciprofloxacin-susceptible and -resistant gram-negative bacteria (CS-GNB and CR-GNB). Patients with CS-GNB received ciprofloxacin while those with CR-GNB received directed prophylaxis. Infectious complications were defined clinically and microbiologically within 30 days after TRUSP. Data were derived at 7 and 30 days post procedure by questionnaires and electronic medical records. We hypothesized that there would be no difference in the infectious outcomes among the CS and CR groups.ResultsFrom November 1, 2012 to March 31, 2015, 510 men completed the study; 430 (84.3%) had CS-GNB and 80 (15.7%) had CR-GNB. 484 (94.9%) completed the study per protocol, while 26 (5.1%) had an intention-to-treat (ITT) analysis. Of the 484, 475 (98.1%) had no infections, nine (1.9%) had infections, six of which (1.2%) were culture-proven (CP). The nine infections were as follows: five (1.0%) uncomplicated UTIs, one (0.2%) complicated UTI, and three (0.6%) urosepsis. One case of uncomplicated UTI and two cases of urosepsis were not CP, but were diagnosed clinically. ITT outcomes were similar. The infection rates were not statistically different between the CS-and CR-GNB patients (p-value = 0.314; 95% CI 0.8-3.3). The four patients with complicated UTIs or sepsis were hospitalized for a mean of 2.6 days and discharged without sequelae. Of the nine infections, three were antimicrobial prophylaxis failures (two ciprofloxacin and one amikacin); three were likely due to failure of the collection or processing of the rectal swab or increasing bacterial resistance between the time of swab collection and biopsy, and three developed clinical infections with no isolate recovered.ConclusionsTargeted antimicrobial prophylaxis follows the principles of antimicrobial stewardship and achieved a low rate of infectious complications with limited morbidity and no sequelae. This individualized method of prophylaxis may be widely applied. Further studies are needed to explore reasons for targeted prophylaxis failure and to determine comparative efficacy of non-ciprofloxacin-containing targeted prophylaxis regimens.Trial registrationClinicalTrials.gov. NCT01659866 . Registered 9 July 2012. First patient enrolled 1 November 2012.

Project description:BackgroundThe preoperative pathological diagnosis of rectal lesions is crucial for formulating treatment plans. For subepithelial lesions (SELs) and larger lesions with necrosis of the rectum, endoscopic forceps biopsy (EFB) cannot provide an accurate pathological diagnosis in most cases. By comparing the efficacy and safety of transrectal contrast-enhanced ultrasound-guided transperineal core-needle biopsy (TRCEUS-TP-CNB) and EFB, this study explored the value of TRCEUS-TP-CNB in the diagnosis of complex rectal lesions, such as SELs.MethodsA retrospective, cross-sectional study was conducted with 32 consecutive patients with complex rectal lesions admitted to our hospital from May 2016 to June 2022. Clinical, ultrasound, and pathological data were collected from these patients who underwent EFB followed by TRCEUS-TP-CNB.ResultsThe success rate of EFB was 21.88% (7/32) and that of TRCEUS-TP-CNB was 93.75% (30/32). No significant complications were observed for either biopsy method. Factors affecting the success rate of EFB included the lesion width (cm) (1.90±0.62 vs. 4.26±2.40, P<0.001) and lesion thickness (cm) (1.29±0.51 vs. 2.96±1.75, P<0.001). The success rate of TRCEUS-TP-CNB was not affected by these factors. In the paired study of TRCEUS-TP-CNB and EFB, the times of samples per person (1 vs. 2.14±0.90, P=0.015), number of specimens per sample (8.27±1.93 vs. 3.31±1.67, P<0.001), lesion width (cm) (3.79±2.42 vs. 1.90±0.62, P=0.001), and lesion thickness (cm) (2.64±1.75 vs. 1.29±0.51, P=0.001) were the factors affecting the difference of the sampling success rate. In the SELs, the success rate of EFB was 10% (1/10) and that of TRCEUS-TP-CNB was 100% (10/10), and the difference between the two groups was statistically significant (P=0.004).ConclusionsTRCEUS-TP-CNB is an effective biopsy method for complex rectal lesions. The success rate of EFB is lower in the larger lesions. Compared with EFB, TRCEUS-TP-CNB required fewer times of samples be taken and obtained more specimens. For larger lesions and SELs of the rectum, TRCEUS-TP-CNB is expected to become one of the preferred biopsy methods.

Dataset Information

Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.

Background

Methods

Results

Conclusions

Publications

Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.

Similar Datasets

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