Malignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative for the management of MPE. However, IPC-related infections remain a significant concern and there are currently no long-term strategies for their prevention. The Australasian Malignant PLeural Effusion (AMPLE)-4 trial is a multicentre randomised trial that evaluates the use of topical mupirocin prophylaxis (vs no mupirocin) to reduce catheter-related infections in patients with MPE treated with an IPC. A pragmatic, multi-centre, open-labelled, randomised trial. Eligible patients with MPE and an IPC will be randomised 1:1 to either regular topical mupirocin prophylaxis or no mupirocin (standard care). For the interventional arm, topical mupirocin will be applied around the IPC exit-site after each drainage, at least twice weekly. Weekly follow-up via phone calls or in person will be conducted for up to 6 months. The primary outcome is the percentage of patients who develop an IPC-related (pleural, skin, or tract) infection between the time of catheter insertion and end of follow-up period. Secondary outcomes include analyses of infection (types and episodes), hospitalisation days, health economics, adverse events, and survival. Subject to interim analyses, the trial will recruit up to 418 participants. Results from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections. Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences. Australia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.

中文翻译：

---

澳大利亚恶性胸腔积液 (AMPLE)-4 试验：局部抗生素预防留置胸膜导管感染的多中心随机试验研究方案

恶性胸腔积液 (MPE) 是一种使人衰弱的疾病，因为它通常会导致呼吸困难并损害生活质量 (QoL)。留置胸膜导管 (IPC) 为 MPE 的治疗提供了有效的替代方案。然而，IPC 相关感染仍然是一个重大问题，目前尚无长期预防策略。澳大利亚恶性胸腔积液 (AMPLE)-4 试验是一项多中心随机试验，评估使用局部莫匹罗星预防（与不使用莫匹罗星）来减少接受 IPC 治疗的 MPE 患者的导管相关感染。一项务实、多中心、开放标签、随机试验。符合条件的 MPE 和 IPC 患者将按 1:1 的比例随机分配接受常规局部莫匹罗星预防或不接受莫匹罗星治疗（标准护理）。对于介入组，每次引流后将在 IPC 出口部位周围局部涂抹莫匹罗星，每周至少两次。每周通过电话或亲自进行随访，为期长达 6 个月。主要结局是在导管插入时和随访期结束期间发生 IPC 相关（胸膜、皮肤或肠道）感染的患者百分比。次要结局包括感染（类型和发作）、住院天数、卫生经济学、不良事件和生存率的分析。根据中期分析，该试验将招募多达 418 名参与者。该试验的结果将确定莫匹罗星预防治疗需要 IPC 治疗 MPE 的患者的疗效。它将提供有关感染率、微生物学以及与 IPC 相关感染相关的潜在感染途径的数据。查尔斯·盖尔德纳爵士和奥斯本公园医疗保健集团人类研究伦理委员会已批准该研究 (RGS0000005920)。结果将发表在同行评审期刊上并在科学会议上展示。澳大利亚新西兰临床试验注册中心 ACTRN12623000253606。注册于 2023 年 3 月 9 日。