Dataset Information

Extended duration vancomycin in recurrent Clostridium difficile infection: a systematic review.

ABSTRACT: Clostridium difficile infections have a high recurrence rate following acute treatment. Extended duration vancomycin (EDV) is a mainstay for the treatment of recurrent Clostridium difficile infections (rCDI). Clinical disease guidelines recommend a variety of different vancomycin treatment regimens though based on weak, low-quality evidence. Patients typically receive an initial vancomycin treatment course of 7-14 days for the acute infection, followed by an extended duration vancomycin course. Multiple publications on the utility of EDV regimens have been published but few include reported effectiveness outcomes associated with a prescribed treatment regimen. The purpose of this review is to evaluate the safety and efficacy data on extended duration vancomycin regimens used in recurrent clostridium treatment. Five articles, three case series and two randomized open-label clinical trials, were identified which included both elements. Outcomes were evaluable in 174 patients, 31 from randomized trials, with prior average recurrent episodes ranging from 3 to 4. Vancomycin dose ranged from 3500 to >6800 mg with therapy durations extending from 21 days to over 60 days. Follow-up duration ranged from 10 weeks to 12 months. Case series reported success rates for EDV in rCDI from 61% to 100%, while randomized trials found lower success rates from 26% to 58%. Taper and pulse regimens reported superior outcomes compared to pulse-only regimens, 58-100% versus 26-81%, respectively. Comparative EDV data is limited. Current available data supports an EDV regimen which includes both a daily dosing taper followed by an every 48 or 72 h pulse.

SUBMITTER: Murphy MM

PROVIDER: S-EPMC6210635 | biostudies-other | 2018 Nov

REPOSITORIES: biostudies-other

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Extended duration vancomycin in recurrent <i>Clostridium difficile</i> infection: a systematic review.

Murphy Madison M MM Patatanian Edna E Gales Mark A MA

Therapeutic advances in infectious disease 20180912 6

Clostridium difficile infections have a high recurrence rate following acute treatment. Extended duration vancomycin (EDV) is a mainstay for the treatment of recurrent <i>Clostridium difficile</i> infections (rCDI). Clinical disease guidelines recommend a variety of different vancomycin treatment regimens though based on weak, low-quality evidence. Patients typically receive an initial vancomycin treatment course of 7-14 days for the acute infection, followed by an extended duration vancomycin c ...[more]

PMID: 30430009

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Project description:Our study sought to compare the strain types of Clostridium difficile causing initial and recurrent episodes of C. difficile infection (CDI) in adult patients with a first episode of CDI or 1 prior episode of CDI within the previous 90 days. Strains originated from patients who had been entered into two phase 3 randomized clinical trials of fidaxomicin versus vancomycin. Isolates of C. difficile from the initial and recurrent episodes within 28 (± 2) days of cure of CDI were compared using restriction endonuclease analysis (REA) typing. Paired isolates were available from 90 of 194 (46%) patients with recurrent CDI. Patients with isolates available were significantly younger (P = .008) and more likely to be from Canadian sites (P = .0001), compared with patients without isolates. In 75 of 90 subjects (83.3%), the identical REA type strain was identified at recurrence and the initial episode (putative relapse). Early recurrences (0-14 days after treatment completion) were relapses in 86.7% and a new strain (reinfection) in 13.3%. Later recurrences (15-31 days after treatment) were relapses in 76.7% and reinfections in 23.3%. Mean time (± standard deviation) to recurrence was 12.2 (± 6.4) days for relapses and 14.7 (± 6.8) days for reinfections (P = .177). The most common BI/NAP1/027 group and the previous US epidemic REA group J/NAP2/001 had a significantly higher combined rate of recurrence with the same strain (relapse), compared with the other REA groups (39 of 42 [93%] vs 36 of 48 [75%], respectively; P = .023). We found a higher than historic rate of recurrent CDI caused by the same isolate as the original episode, a finding that may be related to the relatively short observation period in this study and the high frequency of isolation of epidemic strains, such as groups BI and J, for which relapse rates may be higher than for other REA groups. Caution in generalizing these observations is required, because the patients studied were younger and more likely to be from Canadian sites than were patients with recurrence who did not provide isolates.

Project description:ImportanceGastric acid suppression has been associated with an increased risk of primary Clostridium difficile infection (CDI), but the risk of recurrent CDI in patients taking gastric acid suppressant medications is unclear.ObjectiveTo perform a systematic review and meta-analysis to evaluate the association between gastric acid suppressants and recurrent CDI.Data sourcesMEDLINE, EMBASE, the Cochrane Central Register, the Cochrane Database, and Web of Science were searched from January 1, 1995, to September 30, 2015, for studies assessing the association between gastric acid suppressant exposure and recurrent CDI. Search terms included Clostridium difficile, pseudomembranous colitis, proton pump inhibitor, and histamine H2 blocker.Study selectionCase-control studies, cohort studies, and clinical trials that included patients with CDI who did or did not receive gastric acid suppressant therapy and who were evaluated for recurrent CDI were included, with no restriction on study setting (inpatient or outpatient).Data extraction and synthesisThe Newcastle-Ottawa scale was used to assess the methodologic quality of included studies. In this scale, case-control and cohort studies were scored on selection, comparability, and ascertainment of the outcome of interest. Data were independently abstracted to a predetermined collection form by 2 investigators. Summary odds ratio estimates with 95% CIs were calculated using the random-effects model and software to calculate the pooled effect size of studies reporting multivariate analyses.Main outcomes and measuresRisk of recurrent infection in patients with CDI and its association with use of gastric acid suppressant medication.ResultsSixteen observational studies were included, together reporting 7703 patients with CDI; among these, 1525 patients (19.8%) developed recurrent CDI. The rate of recurrent CDI in patients with gastric acid suppression was 22.1% (892 of 4038 patients) compared with 17.3% (633 of 3665) in patients without gastric acid suppression, which indicated an increased risk by meta-analysis (odds ratio [OR], 1.52; 95% CI, 1.20-1.94; P < .001). There was significant heterogeneity among the studies, with an I2 value of 64%. Subgroup analyses of studies adjusting for age and potential confounders confirmed an increased risk of recurrent CDI with use of gastric acid suppressants (OR, 1.38; 95% CI, 1.08-1.76; P = .02).Conclusions and relevanceMeta-analyses of observational studies suggest that patients who receive gastric acid suppressants may be at increased risk for recurrent CDI. These data should be interpreted with caution because they may be confounded owing to the observational design of the individual studies. It may be reasonable to re-evaluate the need for these medications in patients with CDI.

Project description:CONTEXT: Identifying patients at risk for adverse outcomes of Clostridium difficile infection (CDI), including recurrence and death, will become increasingly important as novel therapies emerge, which are more effective than traditional approaches but very expensive. Clinical prediction rules (CPRs) can improve the accuracy of medical decision-making. Several CPRs have been developed for CDI, but none has gained a widespread acceptance. METHODS: We systematically reviewed studies describing the derivation or validation of CPRs for unfavourable outcomes of CDI, in medical databases (Medline, Embase, PubMed, Web of Science and Cochrane) and abstracts of conferences. RESULTS: Of 2945 titles and abstracts screened, 13 studies on the derivation of a CPR were identified: two on recurrences, five on complications (including mortality), five on mortality alone and one on response to treatment. Two studies on the validation of different severity indices were also retrieved. Most CPRs were developed as secondary analyses using cohorts assembled for other purposes. CPRs presented several methodological limitations that could explain their limited use in clinical practice. Except for leukocytosis, albumin and age, there was much heterogeneity in the variables used, and most studies were limited by small sample sizes. Eight models used a retrospective design. Only four studies reported the incidence of the outcome of interest, even if this is essential to evaluate the potential usefulness of a model in other populations. Only five studies performed multivariate analyses to adjust for confounders. CONCLUSIONS: The lack of weighing variables, of validation, calibration and measures of reproducibility, the weak validities and performances when assessed, and the absence of sensitivity analyses, all led to suboptimal quality and debatable utility of those CPRs. Evidence-based tools developed through appropriate prospective cohorts would be more valuable for clinicians than empirically-developed CPRs.

Dataset Information

Extended duration vancomycin in recurrent Clostridium difficile infection: a systematic review.

Publications

Extended duration vancomycin in recurrent <i>Clostridium difficile</i> infection: a systematic review.

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