| NCT ID | NCT07337993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Health Sciences Lahore |
| Condition | Pyothorax |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Fungal empyema thoracis is a rare but life-threatening pleural infection caused by fungal organisms such as Aspergillus and Candida species. It typically occurs in immunocompromised or debilitated patients and carries a high mortality rate. Conventional management involves systemic antifungal therapy and surgical decortication; however, many patients are unfit for surgery due to poor clinical status or multiple comorbidities. The use of local intrapleural antifungal therapy remains poorly studied. Objective: This study aims to evaluate the efficacy and safety of pleural lavage with voriconazole in patients with fungal empyema thoracis, both as a pre-surgical adjunct and as a palliative measure for patients who cannot undergo surgery. Methods: A prospective cohort study will be conducted at the Department of Thoracic Surgery, Services Hospital, Lahore. Patients diagnosed with fungal empyema confirmed by pleural fluid culture or cytology will be included. Through an indwelling chest tube, voriconazole (200 mg in 100 mL normal saline) will be instilled into the pleural cavity once daily for three consecutive days. Patients will be assessed for improvement in clinical symptoms, radiological clearance, reduction in fungal load, and the need for surgical intervention. Data will be statistically analyzed to determine treatment response and safety outcomes. Conclusion: Pleural lavage with voriconazole offers a promising, minimally invasive approach for managing fungal empyema thoracis. If proven effective, this method could serve as a valuable addition to current antifungal strategies, improving outcomes for critically ill patients who are not candidates for surgery.
Eligibility Criteria
Inclusion Criteria: * All age patients with confirmed fungal empyema thoracis. * Patients with adequate pleural drainage through an intercostal chest tube. * Patients receiving systemic antifungal therapy. * Patients either: 1. scheduled for surgical decortication but undergoing lavage as a preoperative adjunct, or 2. considered unfit for surgery and managed conservatively. Exclusion Criteria: * Bacterial empyema without fungal growth. * Known hypersensitivity to anti-fungals. * Severe hepatic impairment (Child-Pugh class C) contraindicating voriconazole. * Pregnancy or lactation. * Refusal to participate.
Contact & Investigator
Muhammad Shoaib Nabi, FCPS
STUDY CHAIR
Saglik Bilimleri Universitesi
Frequently Asked Questions
Who can join the NCT07337993 clinical trial?
This trial is open to participants of all sexes, studying Pyothorax. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07337993 currently recruiting?
Yes, NCT07337993 is actively recruiting participants. Contact the research team at zeeshan.sarwar195@gmail.com for enrollment information.
Where is the NCT07337993 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07337993 clinical trial?
NCT07337993 is sponsored by University of Health Sciences Lahore. The principal investigator is Muhammad Shoaib Nabi, FCPS at Saglik Bilimleri Universitesi. The trial plans to enroll 50 participants.