Clostridium difficile Infection is Associated with Poor Outcomes in End-Stage Renal Disease

Pant, Chaitanya; Deshpande, Abhishek; Anderson, Michael P.; Sferra, Thomas J.

doi:10.2310/jim.0b013e318242b313

Cited by 20 publications

(37 citation statements)

References 16 publications

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“…9,15 In addition, CDI in patients with IBD is frequently community acquired. [16][17][18] Similar to what is described for other chronic disorders, 19,20 CDI is a significant complicating factor in the disease course of patients with IBD. 10,21 Adult patients with IBD who develop CDI have worse clinical outcomes including an increased risk of mortality as compared with those without this infection.…”

mentioning

confidence: 64%

Health Care Burden of Clostridium difficile Infection in Hospitalized Children with Inflammatory Bowel Disease

Pant

Anderson

Deshpande

et al. 2013

Inflammatory Bowel Diseases

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confidence: 64%

Health Care Burden of Clostridium difficile Infection in Hospitalized Children with Inflammatory Bowel Disease

Pant

Anderson

Deshpande

et al. 2013

Inflammatory Bowel Diseases

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“…Th e 33 new studies did outline the economic burden of CDI in three additional countries (Australia ( 34 ), Germany ( 4 ), and Japan ( 6 )) and several diff erent patient populations (e.g., children ( 39,41,56 ), cancer patients ( 6,37,45 ), patients with renal disease ( 37,40,50 ), transplant patients ( 44,49 ), outpatients ( 46 ) and community-acquired CDI ( 41 )). Also, one study incorporated indirect ( 48 ) costs in their analysis.…”

Section: Discussionmentioning

confidence: 99%

“…In the following patient populations that were studied, statistically signifi cant higher costs were found among CDI patients (vs. a comparison group, where most studies compared to those without CDI): any hospitalization ( 38,(57)(58)(59)70 ); children ( 39,56 ); adults ( 38,40,57 ); individuals aged ≥65 years ( 37,40 ); those with a history of CDI ( 40 ); admitted to the intensive care unit ( 67 ); nonsurgical ( 64 ); surgical ( 69 ); undergoing colon resections ( 55 ), radical cystectomy ( 45 ), digestive tract surgery ( 6 ), or closure of loop ileostomy ( 43 ); undergoing solid-organ ( 49 ) or liver ( 44 ) transplant; have cancer ( 6,45 ); have infl ammatory bowel disease ( 39,40,65 ); have cirrhosis ( 60 ); have renal disease ( 37,40,50 ); on prolonged acute mechanical ventilation ( 63 ); and taking concomitant antibiotics ( 37,40 ).…”

Section: Quality Assessment Of Coi Studiesmentioning

confidence: 99%

“…Th e majority of costs were calculated over the duration of a hospital stay (39 studies, 87% ( 4-8,34,35,37-45,47,49-52, 54-70,72 )). In addition, the most common resource and cost source was large health administrative databases (29 studies, 64% ( 6,8,34,(37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(49)(50)(51)(52)(54)(55)(56)(57)(58)(59)(60)(61)63,65,69 )). …”

Section: Coi Study Characteristicsmentioning

confidence: 99%

“…Most studies met the following quality criteria: mentioned the time horizon for which costs were calculated over (45 studies, 100% (4)(5)(6)(7)(8)), stated the cost outcomes being evaluated (43 studies, 96% (4)(5)(6)(7)(8)34,), reported the resource utilization variables separately from unit costs (40 studies, 89% ( 4-8, 35-52,54-58,60,62-70,72,73 )), described the resource utilization and cost sources (38 studies, 84% (4)(5)(6)8,(37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(54)(55)(56)(57)(58)(59)(60)(61)(63)(64)(65)(66)(67)(68)(69)(70)(71)…”

Section: Quality Assessment Of Coi Studiesmentioning

confidence: 99%

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The Economic Impact of Clostridium difficile Infection: A Systematic Review

Nanwa

Kendzerska

Krahn

et al. 2015

American Journal of Gastroenterology

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Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection

et al. 2023

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ImportanceA safe and effective treatment for recurrent Clostridioides difficile infection (CDI) is urgently needed. Antibiotics kill toxin-producing bacteria but do not repair the disrupted microbiome, which promotes spore germination and infection recurrence.ObjectivesTo evaluate the safety and rate of CDI recurrence after administration of investigational microbiome therapeutic SER-109 through 24 weeks.Design, Setting, and ParticipantsThis phase 3, single-arm, open-label trial (ECOSPOR IV) was conducted at 72 US and Canadian outpatient sites from October 2017 to April 2022. Adults aged 18 years or older with recurrent CDI were enrolled in 2 cohorts: (1) rollover patients from the ECOSPOR III trial who had CDI recurrence diagnosed by toxin enzyme immunoassay (EIA) and (2) patients with at least 1 CDI recurrence (diagnosed by polymerase chain reaction [PCR] or toxin EIA), inclusive of their acute infection at study entry.InterventionsSER-109 given orally as 4 capsules daily for 3 days following symptom resolution after antibiotic treatment for CDI.Main Outcomes and MeasuresThe main outcomes were safety, measured as the rate of treatment-emergent adverse events (TEAEs) in all patients receiving any amount of SER-109, and cumulative rates of recurrent CDI (toxin-positive diarrhea requiring treatment) through week 24 in the intent-to-treat population.ResultsOf 351 patients screened, 263 were enrolled (180 [68.4%] female; mean [SD] age, 64.0 [15.7] years); 29 were in cohort 1 and 234 in cohort 2. Seventy-seven patients (29.3%) were enrolled with their first CDI recurrence. Overall, 141 patients (53.6%) had TEAEs, which were mostly mild to moderate and gastrointestinal. There were 8 deaths (3.0%) and 33 patients (12.5%) with serious TEAEs; none were considered treatment related by the investigators. Overall, 23 patients (8.7%; 95% CI, 5.6%-12.8%) had recurrent CDI at week 8 (4 of 29 [13.8%; 95% CI, 3.9%-31.7%] in cohort 1 and 19 of 234 [8.1%; 95% CI, 5.0%-12.4%] in cohort 2), and recurrent CDI rates remained low through 24 weeks (36 patients [13.7%; 95% CI, 9.8%-18.4%]). At week 8, recurrent CDI rates in patients with a first recurrence were similarly low (5 of 77 [6.5%; 95% CI, 2.1%-14.5%]) as in patients with 2 or more recurrences (18 of 186 [9.7%; 95% CI, 5.8%-14.9%]). Analyses by select baseline characteristics showed consistently low recurrent CDI rates in patients younger than 65 years vs 65 years or older (5 of 126 [4.0%; 95% CI, 1.3%-9.0%] vs 18 of 137 [13.1%; 95% CI, 8.0%-20.0%]) and patients enrolled based on positive PCR results (3 of 69 [4.3%; 95% CI, 0.9%-12.2%]) vs those with positive toxin EIA results (20 of 192 [10.4%; 95% CI, 6.5%-15.6%]).Conclusions and RelevanceIn this trial, oral SER-109 was well tolerated in a patient population with recurrent CDI and prevalent comorbidities. The rate of recurrent CDI was low regardless of the number of prior recurrences, demographics, or diagnostic approach, supporting the beneficial impact of SER-109 for patients with CDI.Trial RegistrationClinicalTrials.gov identifier: NCT03183141

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Clostridium difficile Infection is Associated with Poor Outcomes in End-Stage Renal Disease

Abstract: Clostridium difficile infection is associated with significantly worse outcomes in hospitalized patients with ESRD.

Cited by 20 publications

References 16 publications

Health Care Burden of Clostridium difficile Infection in Hospitalized Children with Inflammatory Bowel Disease

Health Care Burden of Clostridium difficile Infection in Hospitalized Children with Inflammatory Bowel Disease

The Economic Impact of Clostridium difficile Infection: A Systematic Review

Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection

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