Clinical Outcomes and Management of NAAT-Positive/Toxin-Negative Clostridioides difficile Infection: A Systematic Review and Meta-Analysis

Link to article at PubMed

Clin Infect Dis. 2023 Aug 30:ciad523. doi: 10.1093/cid/ciad523. Online ahead of print.


BACKGROUND: Standalone nucleic acid amplification tests (NAATs) are frequently used to diagnose Clostridioides difficile infections (CDI), although they may be unable to distinguish colonization from disease. A two-stage algorithm pairing NAATs with toxin immunoassays (Toxin) may improve specificity. We evaluated clinical outcomes of patients who were NAAT+/Toxin + versus NAAT+/Toxin- and treated versus untreated NAAT+/Toxin- cases through systematic review and meta-analysis.

METHODS: We searched EMBASE and MEDLINE from inception to April 1, 2023 for articles comparing CDI outcomes among symptomatic patients tested by NAAT and Toxin tests. The risk differences (RD) of all-cause mortality and CDI recurrence were computed by random effects meta-analysis between patients who were NAAT+/Toxin + and NAAT+/Toxin-, as well as between patients who were NAAT+/Toxin- and treated or untreated.

RESULTS: Twenty-six observational studies comprising 12737 patients were included. 30-Day all-cause mortality was not significantly different between those who were NAAT+/Toxin + (8.4%) and NAAT+/Toxin- (6.7%) (RD = 0.41%, 95%Confidence interval [95%CI]=-0.67, 1.49). Recurrence at 60 days was significantly higher among patients who were NAAT+/Toxin + (19.8%) versus NAAT+/Toxin- (11.0%) (RD = 7.65%, 95%CI = 4.60, 10.71). Among treated compared to untreated NAAT+/Toxin- cases, the all-cause 30-day mortalities were 5.0% and 12.7%, respectively (RD = -7.45%, 95%CI = -12.29, -2.60), but 60-day recurrence was not significantly different (11.6% versus 7.0%, respectively; RD = 5.25%, 95%CI -1.71, 12.22).

CONCLUSION: Treatment of patients who were NAAT+/Toxin- was associated with reduced all-cause mortality, but not recurrence. While subject to the inherent limitations of observational studies, these results suggest that some patients who are NAAT+/Toxin- may benefit from treatment.

PMID:37648251 | DOI:10.1093/cid/ciad523

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