Fungal Empyema Thoracis

NCT07337993 | Recruiting DMC

• 1 other identifier: IRB/2025/1720/SIMS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyothorax; Fungal Infection Lungs; Pleural Empyema

Keywords

Fungal Pyothorax; pleural lavage; anti-fungals

Outcome Measures

Primary Outcomes (1)

• Expansion of Lung

  Complete re-expansion was defined as ≥90% aeration of the ipsilateral hemithorax on postero-anterior (or AP) chest radiograph.

  one month post operatively

Secondary Outcomes (1)

• Complications

  one month post-operatively

Study Arms (3)

pleural lavage group

EXPERIMENTAL

participants of this group are diagnosed as having fungal empyema on investigations of pleural fluid before any kind of surgical intervention is carried out.

Procedure: pleural lavage followed by surgery

Surgical group

ACTIVE COMPARATOR

Participants of this group are misdiagnosed as having bacterial empyema before surgery, but diagnosed as having fungal empyema intra-operatively or after surgery on post-operative culture results.

Procedure: Decortication

Non-surgical group

ACTIVE COMPARATOR

participants of this group are diagnosed as having fungal empyema and they are unfit for any kind of surgical intervention and are only managed with pleural lavage with anti-fungal drugs.

Other: Conservative Arm

Interventions

pleural lavage followed by surgery PROCEDURE

participants of this group are managed with pleural lavage with anti-fungals and than decortication is performed.

pleural lavage group

Decortication PROCEDURE

patient underwent direct surgery for fungal empyema

Surgical group

Conservative Arm OTHER

patients are only managed with pleural lavage

Non-surgical group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• scheduled for surgical decortication but undergoing lavage as a preoperative adjunct, or
• considered unfit for surgery and managed conservatively.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Empyema, Pleural

Interventions

Cerebral Decortication

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Muhammad Shoaib Nabi, FCPS

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Central Study Contacts

Zeeshan Sarwar, MBBS

CONTACT

+923214347410; zeeshan.sarwar195@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

PA (1)