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Citius Pharma's 'Antibiotic Lock' Effective In Patients With Catheter-Associated Bloodstream Infections

Citius Pharma's 'Antibiotic Lock' Effective In Patients With Catheter-Associated Bloodstream Infections

Citius Pharma 的 “抗生素锁” 对导管相关血液感染患者有效
Benzinga ·  05/21 13:40

Tuesday, Citius Pharmaceuticals Inc. (NASDAQ:CTXR) announced the topline results of its Phase 3 trial of Mino-Lok, an antibiotic lock solution designed to salvage catheters in patients with central line-associated infections (CLABSI) or catheter-related bloodstream infections (CRBSI).

周二,Citius Pharmicals Inc.(纳斯达克股票代码:CTXR)公布了其Mino-Lok的3期试验的主要结果。Mino-Lok是一种抗生素锁解决方案,旨在挽救中枢线相关感染(CLABSI)或导管相关血流感染(CRBSI)患者的导管。

The study met its primary endpoint with a statistically significant improvement in the time to failure event in patients receiving Mino-Lok compared to Control arm patients receiving clinician-directed anti-infective lock solution.

与接受临床医生指导的抗感染锁定溶液的对照组患者相比,该研究达到了主要终点,接受Mino-Lok的患者的失败时间有了统计学上的显著改善。

Catheter failure was defined as the inability to administer study lock solution, catheter removal for any infection-related reason (including worsening clinical signs and symptoms or persistence or recurrence of baseline pathogen, or new infection), and all-cause mortality.

导管失效被定义为无法使用研究锁定溶液、因任何感染相关原因(包括临床体征和症状恶化或基线病原体持续或复发或新发感染)而切除导管,以及全因死亡。

Time to catheter failure events in patients receiving Mino-Lok therapy occurred substantially later than in patients in the Control arm (p-value = 0.0006).

接受 Mino-Lok 治疗的患者发生导管失效事件的时间比对照组患者发生导管失效的时间要晚得多 (p 值 = 0.0006)。

  • Median time-to-failure (MTF) of the Control arm: 33 days.
  • MTF of Mino-Lok arm: MTF exceeded the time the patients were on trial and, therefore, not estimable.
  • 控制组的平均故障时间 (MTF):33 天。
  • Mino-Lok 组的 MTF:MTF 超过了患者接受试验的时间,因此无法估计。

The hazard ratio of this study was 0.53.

这项研究的危险比为0.53。

The critical secondary endpoints included the proportion of patients at six weeks with overall treatment success, including no catheter failure, clinical cure (absence of baseline clinical signs and symptoms of infection or improvement of clinical signs and symptoms such that no additional therapy was necessary), or microbiological eradication (absence of the baseline pathogen).

关键的次要终点包括在六周内获得总体治疗成功的患者比例,包括没有导管失效、临床治愈(没有基线临床体征和感染症状或临床体征和症状改善,因此无需额外治疗)或微生物根除(缺乏基线病原体)。

Results in all randomized patients who received at least one dose of study lock solution demonstrate overall treatment success in 57.1% of patients in the Mino-Lok arm and 37.7% of patients in the Control arm (p=0.0025).

所有接受至少一剂研究锁溶液的随机患者的结果显示,Mino-Lok 组有 57.1% 的患者和 37.7% 的对照组患者的总体治疗成功 (p=0.0025)

The data demonstrate that Mino-Lok is well-tolerated. No serious adverse events were drug-related.

数据表明,Mino-Lok的耐受性良好。没有严重的不良事件与药物有关。

Serious adverse events occurred in 45.1% of patients in the Mino-Lok arm and 46.1% in the Control arm.

严重的不良事件发生在Mino-Lok组的患者中有45.1%,对照组有46.1%的患者发生了严重的不良事件。

Price Action: CTXR shares are up 12.20% at $0.74 at last check Tuesday.

价格走势:周二最后一次检查时,CTXR股价上涨12.20%,至0.74美元。

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