Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062153) titled 'Effectiveness of Ceftolozane/Tazobactam Versus Polymyxins or Aminoglycosides for Multidrug-Resistant Pseudomonas aeruginosa Infections: A Systematic Review and Meta-Analysis' on July 7.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Tohoku Medical and Pharmaceutical University

Condition: Condition - Multidrug-resistant (MDR), extensively drug-resistant (XDR), or difficult-to-treat resistance (DTR) Pseudomonas aeruginosa infections Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Multidrug-resistant (MDR) Pseudomonas aeruginosa infections are serious public health problems. Therefore, establishing effective therapeutic strategies is necessary. Historically, polymyxins and aminoglycosides were used for treatment; however, a major side effect is nephrotoxicity, which remains a significant clinical problem. Recently, novel beta-lactam/beta-lactamase inhibitor combinations, including ceftolozane/tazobactam, can be used against MDR P. aeruginosa, and several studies were performed.A meta-analysis by Chi et al. reported the efficacy and lower risk of acute kidney injury (AKI) of ceftolozane/tazobactam compared with polymyxins or aminoglycosides for gram-negative infections. However, limitations included the inclusion of infections regardless of drug resistance, and various AKI definitions. After that, a network meta-analysis by Collings et al. against MDR P. aeruginosa demonstrated that ceftolozane/tazobactam significantly improved clinical cure and reduced mortality. However, that study focused only on efficacy endpoints and did not evaluate AKI outcomes.Regarded as an evolution of the concept of Acute Renal Failure (ARF), Acute Kidney Injury (AKI) was introduced by the ADQI working group in 2004 to capture earlier declines in renal function. Although standardized criteria were established, such as the RIFLE classification defined that year and its evolution into the KDIGO criteria in 2012, past clinical studies often relied on inconsistent AKI definitions, resulting in a lack of robust evaluation.To overcome these limitations, we performed a systematic review and meta-analysis of literature published up to May 2026. By limiting criteria to studies on MDR P. aeruginosa infections that concurrently reported mortality and AKI incidence, we aimed to evaluate the efficacy and safety of ceftolozane/tazobactam-based therapy versus polymyxin- or aminoglycoside-based regimens. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Studies were eligible for inclusion if they evaluated hospitalized adult patients with multidrug-resistant Pseudomonas aeruginosa infection and compared ceftolozane/tazobactam-based therapy directly against polymyxin- or aminoglycoside-based regimens. Eligible studies were required to report both all-cause mortality and the incidence of acute kidney injury (AKI). For investigations evaluated a broader cohort receiving various novel cephems or other agents, inclusion was restricted to those from which data specific to the ceftolozane/tazobactam cohort could be isolated. Relevant literature was retrieved from major databases, including PubMed, Web of Science, and the Cochrane Library, without language restrictions. Key exclusion criteria - Under 18 years old Pregnancy Inability to isolate MDR data (e.g., non-MDR P. aeruginosa or Enterobacterales predominant) Missing primary outcomes (all-cause mortality or AKI incidence) Incomplete full-text/data (letters, reviews, or conference abstracts only) Target Size - 8

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2026 Year 06 Month 01 Day Date of IRB - 2026 Year 06 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2026 Year 06 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070683

Disclaimer: Curated by HT Syndication.