PyothoraxNCT07337993
Fungal Empyema Thoracis
A study testing pleural lavage followed by surgery, Decortication and Conservative Arm in people with Pyothorax and Fungal Infection Lungs, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pyothorax, Fungal Infection Lungs, Pleural Empyema
- What is being tested?
- pleural lavage followed by surgery, Decortication and Conservative Arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Services Hospital Lahore
Lahore, Punjab Province, 54000
Muhammad Shoaib Nabi, FCPS, +923009403511, one111@gmail.com
About this study
Official title: Efficacy of Pleural Lavage With Antifungals in the Management of Fungal Empyema Thoracis: A Prospective Cohort Study
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.
Read more
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.
Read the detailed description
Empyema thoracis remains an important cause of morbidity and mortality worldwide. While the vast majority of pleural space infections are bacterial, fungal empyema is a distinct and increasingly recognized clinical entity that carries substantially higher mortality and a more complex therapeutic course than typical bacterial empyema. Fungal empyema most commonly occurs in patients with significant comorbidities or healthcare exposures (e.g., recent thoracic surgery, prolonged antibiotics, gastrointestinal perforation, or immunosuppression) and is frequently due to Candida or Aspergillus species. Reported crude mortality rates range between 40-70%, which are considerably higher than for bacterial empyema [1, 2].
Standard management of fungal empyema combines prompt pleural drainage with systemic antifungal therapy and, when indicated, surgical intervention (decortication or debridement) in the presence of loculation, trapped lung, or persistent sepsis [3]. However, surgical treatment is often high-risk because many patients are elderly, immunocompromised, or poor surgical candidates. Even when surgery is performed, fungal empyema is associated with increased intra- and postoperative complications and prolonged hospitalization compared with bacterial empyema [4]. These challenges underscore the need for adjunctive or alternative strategies that can enhance pleural sterilization, control sepsis, and either avert or optimize the timing of definitive surgery.
Voriconazole, a second-generation triazole antifungal, demonstrates excellent activity against Aspergillus and Candida species and has favorable pleural space penetration when administered systemically [5]. Local administration of antifungal agents directly into the pleural cavity has been described in isolated reports, with encouraging outcomes using agents such as amphotericin B and voriconazole [6-8]. Pleural lavage (intrapleural irrigation) allows high local drug concentrations at the infected pleural surface, improving fungal clearance while minimizing systemic toxicity. Case reports have demonstrated successful outcomes using intrapleural antifungal lavage as adjunct therapy or as a palliative measure in patients who could not undergo surgical decortication [7-9].
Despite these encouraging findings, there remains a paucity of prospective evidence evaluating the efficacy and safety of pleural lavage with voriconazole in fungal empyema. To address this gap, we designed a prospective cohort study to assess the outcomes of pleural lavage with voriconazole in patients with confirmed fungal empyema. The primary objectives are to evaluate (1) the effectiveness of intrapleural voriconazole lavage as an adjunct prior to surgical decortication and (2) its potential as a palliative option for patients unfit for surgery. Secondary outcomes include pleural sterilization rates, clinical improvement, conversion to surgery, length of hospital stay, and treatment-related adverse effects. This study aims to provide clinical evidence supporting the role of local antifungal therapy in optimizing the management of fungal empyema, particularly in high-risk and resource-limited settings.
- Conditions
- Pyothorax, Fungal Infection Lungs, Pleural Empyema
- Being tested
- pleural lavage followed by surgery, Decortication, Conservative Arm
- Keywords
- Fungal Pyothorax, pleural lavage, anti-fungals
- Medical subject headings
- Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleural lavage followed by surgeryProcedure or surgery
participants of this group are managed with pleural lavage with anti-fungals and than decortication is performed.
DecorticationProcedure or surgery
patient underwent direct surgery for fungal empyema
Conservative ArmOther
patients are only managed with pleural lavage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Conservative Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expansion of Lung
Complete re-expansion was defined as ≥90% aeration of the ipsilateral hemithorax on postero-anterior (or AP) chest radiograph.
Measured: one month post operatively
Secondary outcomes (1)
Complications
Post-operative complications in active surgical group and in conservative group
Measured: one month post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Sarwar, University of Health Sciences Lahore
- Investigators
- Muhammad Shoaib Nabi, FCPS, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337993
- Sponsor's protocol ID
- IRB/2025/1720/SIMS
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pleural Lavage With Antifungals in the Management of Fungal Empyema Thoracis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07337993
- Acronym / sponsor ID
- IRB/2025/1720/SIMS
- Conditions
- Pyothorax, Fungal Infection Lungs, Pleural Empyema
- Keywords
- Fungal Pyothorax, pleural lavage, anti-fungals
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Empyema thoracis remains an important cause of morbidity and mortality worldwide. While the vast majority of pleural space infections are bacterial, fungal empyema is a distinct and increasingly recognized clinical entity that carries substantially higher mortality and a more complex therapeutic course than typical bacterial empyema. Fungal empyema most commonly occurs in patients with significant comorbidities or healthcare exposures (e.g., recent thoracic surgery, prolonged antibiotics, gastrointestinal perforation, or immunosuppression) and is frequently due to Candida or Aspergillus species. Reported crude mortality rates range between 40-70%, which are considerably higher than for bacterial empyema [1, 2].
Standard management of fungal empyema combines prompt pleural drainage with systemic antifungal therapy and, when indicated, surgical intervention (decortication or debridement) in the presence of loculation, trapped lung, or persistent sepsis [3]. However, surgical treatment is often high-risk because many patients are elderly, immunocompromised, or poor surgical candidates. Even when surgery is performed, fungal empyema is associated with increased intra- and postoperative complications and prolonged hospitalization compared with bacterial empyema [4]. These challenges underscore the need for adjunctive or alternative strategies that can enhance pleural sterilization, control sepsis, and either avert or optimize the timing of definitive surgery.
Voriconazole, a second-generation triazole antifungal, demonstrates excellent activity against Aspergillus and Candida species and has favorable pleural space penetration when administered systemically [5]. Local administration of antifungal agents directly into the pleural cavity has been described in isolated reports, with encouraging outcomes using agents such as amphotericin B and voriconazole [6-8]. Pleural lavage (intrapleural irrigation) allows high local drug concentrations at the infected pleural surface, improving fungal clearance while minimizing systemic toxicity. Case reports have demonstrated successful outcomes using intrapleural antifungal lavage as adjunct therapy or as a palliative measure in patients who could not undergo surgical decortication [7-9].
Despite these encouraging findings, there remains a paucity of prospective evidence evaluating the efficacy and safety of pleural lavage with voriconazole in fungal empyema. To address this gap, we designed a prospective cohort study to assess the outcomes of pleural lavage with voriconazole in patients with confirmed fungal empyema. The primary objectives are to evaluate (1) the effectiveness of intrapleural voriconazole lavage as an adjunct prior to surgical decortication and (2) its potential as a palliative option for patients unfit for surgery. Secondary outcomes include pleural sterilization rates, clinical improvement, conversion to surgery, length of hospital stay, and treatment-related adverse effects. This study aims to provide clinical evidence supporting the role of local antifungal therapy in optimizing the management of fungal empyema, particularly in high-risk and resource-limited settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pleural lavage group | Experimental | Procedure: pleural lavage followed by surgeryparticipants of this group are diagnosed as having fungal empyema on investigations of pleural fluid before any kind of surgical intervention is carried out. |
| Surgical group | Active comparator | Procedure: DecorticationParticipants 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. |
| Non-surgical group | Active comparator | Other: Conservative Armparticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pleural lavage followed by surgeryparticipants of this group are managed with pleural lavage with anti-fungals and than decortication is performed. | Procedure or surgery | pleural lavage group |
| Decorticationpatient underwent direct surgery for fungal empyema | Procedure or surgery | Surgical group |
| Conservative Armpatients are only managed with pleural lavage | Other | Non-surgical group |
Primary outcome
Expansion of Lung
Time frame: one month post operatively
Complete re-expansion was defined as ≥90% aeration of the ipsilateral hemithorax on postero-anterior (or AP) chest radiograph.
1 secondary outcome
Complications
Time frame: one month post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Shoaib Nabi, FCPS study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pleural lavage followed by surgery, Decortication and Conservative Arm in people with Pyothorax and Fungal Infection Lungs, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeeshan Sarwar, MBBS (+923214347410, zeeshan.sarwar195@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expansion of Lung (time frame: one month post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.