The Australasian Malignant PLeural Effusion (AMPLE)-4 Trial: Topical Antibiotic Prophylaxis for Infections of Indwelling Pleural Catheters in Patients with Malignant Pleural Effusions

Phase 1

Recruiting

• Conditions: Malignant pleural effusion; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases; Cancer - Lung - Mesothelioma; Cancer - Other cancer types

• Registration Number: ACTRN12623000253606
• Lead Sponsor: Institute for Respiratory Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-09
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

Patients who require insertion of an IPC for control of malignant pleural effusion (MPE).
°MPE is defined as an effusion in which cancer cells are identified in the fluid or pleural biopsy; or is a large exudative effusion without other causes in a patient with advanced disseminated malignancy.

Exclusion Criteria

1. Age <18 yrs
2. Allergy to mupirocin
3. Ipsilateral pleural infection within past three months
4.Inability to consent
5. Inability to comply with the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the percentage of patients who developed an IPC-related infection from catheter insertion until death, or end of 6-month follow-up. IPC-related infection can be any one of the followings: <br>• Pleural infection: presence of pus and/or bacteria by Gram stain or culture in pleural fluid plus clinical picture compatible with infection (eg fever, leucocytosis, raised inflammatory markers). <br>• Catheter tract infection: signs of inflammation along the tract usually with swelling and significant tenderness plus clinical presentation compatible with infection. <br>• Cellulitis at exit site: signs of inflammation clinically warranting systemic antibiotic treatment as determined by the attending physician.<br>[ weekly from randomisation until death or 6 months post-randomisation follow-up (if IPC is removed, then follow-ups will be monthly)]