Fungal Empyema Thoracis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Health Sciences Lahore

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

All age patients with confirmed fungal empyema thoracis.

Patients with adequate pleural drainage through an intercostal chest tube.

Patients receiving systemic antifungal therapy.

scheduled for surgical decortication but undergoing lavage as a preoperative adjunct, or

Disqualifiers

Bacterial empyema without fungal growth.

Known hypersensitivity to anti-fungals.

Severe hepatic impairment (Child-Pugh class C) contraindicating voriconazole.

Pregnancy or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • pleural lavage followed by surgery

    Procedure/Surgery

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

  • Decortication

    Procedure/Surgery

    patient underwent direct surgery for fungal empyema

  • Conservative Arm

    Other intervention

    patients are only managed with pleural lavage

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: pleural lavage groupExperimental treatment 1 intervention
Group B: Surgical groupActive comparator 1 intervention
Group C: Non-surgical groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
one month post operatively

Secondary outcomes

1

Complications

Post-operative complications in active surgical group and in conservative group

Time frame
one month post-operatively

Other outcomes

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