Pleural InfectionSTEPNCT07858721
Study of Medical Thoracoscopy in Early Pleural Infection
A study of Pleural Infection, run by Alexandria University.
Trial summary
Pleural infection (which is the infection in the space around the lungs called the pleura) is a severe infection that is difficult to treat and can lead substantial disability or even death. This infection is associated with fluid build up in the pleura and draining this fluid is crucial in treating the infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Infection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Apr 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years old)
- Willing to provide informed consent
- Admitted to hospital for treatment of pleural infection (both parapneumonic and primary pleural infections included). Pleural infection will be defined by the presence of one of the following[10]:
- the presence of pus in the pleural space;
- positive pleural fluid gram stain or culture; or
- pleural fluid pH < 7.2 or pleural fluid glucose < 40 mg/dL (in the setting of acute respiratory infection)
- pleural fluid pH 7.21-7.39 with LDH >900 IU/L with pleural fluid glucose <72 mg/dL, pleural fluid septation in ultrasound, or pleural enhancement on CT (in the setting of acute respiratory infection)
Who cannot join
- Inability to undergo medical thoracoscopy within 72 hours of diagnosis confirmation
- Suspected or proven tuberculous aetiology for the pleural effusion
- Absolute contraindication for medical thoracoscopy per British Thoracic guidelines[11] (uncorrectable bleeding diathesis, significant pulmonary hypertension, cardiovascular instability, uncorrectable hypoxia, ongoing hypercapnia, cutaneous infection, metastasis or rib fracture around port
- insertion site)
- Ipsilateral pleural infection within the last three months from presentation
- Previous ipsilateral thoracic surgery
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- Evidence of chronic pleural infection on clinical or radiological basis (stage III, organizing phase)
- Pleural effusion not amenable to chest drain insertion/medical thoracoscopy due to location (medial or posterior loculation) or size (depth <2cm)
- Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of Medical Thoracoscopy in Early Pleural Infection (STEP) - a Multicentre Randomised Controlled Trial
Pleural infection (which is the infection in the space around the lungs called the pleura) is a severe infection that is difficult to treat and can lead substantial disability or even death. This infection is associated with fluid build up in the pleura and draining this fluid is crucial in treating the infection. The typical method for draining this fluid is inserting a tube in the chest cavity. However, this is not successful in more than one third of patients and additional treatments including surgery are required. These additional treatments are expensive and hence not available in a lot of settings. In addition, patients with this type of infection are often not fit to undergo surgery.
There are studies to suggest that a minor surgical procedure, called medical thoracoscopy, that is carried out by chest doctors and does not require general anaesthesia can help with draining the fluid in the pleura when there is infection. In order to ascertain this benefit, a study is needed to compare the effect of using medical thoracoscopy to not using medical thoracoscopy in treating pleural infection. The choice of patients needs to be in random to ensure the effects are true.
The investigators aim in this study to conduct a randomized study in patients with pleural infection where half the patients will receive the standard chest tube treatment and the other half will have medical thoracoscopy in addition to the standard tube. The study will monitor the treatment outcomes for each group to find out whether the newer treatment improves these outcomes.
Read the detailed description
Infection of the pleural space is serious condition that requires hospitalization, invasive interventions and long courses of antibiotics. Treatment of pleural infection requires long hospital admission with a median of 19 days and medical treatments fails requiring surgical intervention in up to 30% of cases. The mortality from pleural infection is around 10% at 3 months.
The increasing practice of physician-led thoracoscopy has prompted interest into its role in pleural infection. In theory, the ability to perform drainage, mechanically disrupt septations, and insert a chest tube under direct vision would be advantageous. A meta-analysis of eight observational studies found a pooled success rate of 85% when medical thoracoscopy was used as a first-line treatment for pleural infection. A small randomised controlled trial (RCT) comparing medical thoracoscopy with intrapleural enzyme therapy (IET) in patients with incomplete drainage 24 hours after chest-tube insertion concluded that using medical thoracoscopy leads to shorter hospital stays (3.5 vs 6 days for IET) with no between-group differences in rates of treatment failure or mortality[6]. Despite experiences reported in the literature, this treatment has not yet made its way into international guidelines.
The aim of this study is to assess the effect of medical thoracoscopy (within 72 hours from the time the diagnosis is made) in early stage of pleural infection (stage I \& II) versus standard of care on the length of hospitalisation and treatment outcomes.
- Conditions
- Pleural Infection
- Being tested
- Medical thoracoscopy plus standard of care, Standard of Care (Investigator Choice)
- Keywords
- medical thoracoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical thoracoscopy plus standard of careProcedure or surgery
Local anaesthetic thoracoscopy done in spontaneously breathing patients with pleural infection with the aim of optimising drainage of the infected fluid. This will be performed plus standard of care including antibiotics, venous thromboprophylaxis and intrapleural therapy.
Standard of Care (Investigator Choice)Drug
This will include antibiotics, venous thromboprophylaxis and intrapleural therapy.
| Study group | Role | What they receive |
|---|---|---|
| Medical thoracoscopy | Experimental | Patients with pleural infection receiving standard of care treatment plus medical thoracoscopy Receives: Procedure: Medical thoracoscopy plus standard of care |
| Standard of care arm | Active comparator | Patients with pleural infection receiving standard of care treatment Receives: Drug: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Duration of initial hospital stay
Measured: From the date of randomization to the date of discharge from hospital or the date of death for participants whichever happens first assessed up to 12 months
Secondary outcomes (1)
Proportion of patients who need further ipsilateral interventions to control pleural infection within 30 days from randomisation
Additional drainage interventions include chest tube, thoracentesis or surgical evacuation
Measured: Duration of recording of the outcome will be from randomisation to 30 days after that day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pleural InfectionStudies 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
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University, Mansoura University, Ain Shams University
- Responsible party
- Principal investigator, Maged Hassan, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858721
- Sponsor's protocol ID
- 0308114
- Acronym
- STEP
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared with other researchers upon reasonable request from the chief investigator and this is after the study results are published.
Publications
Kheir F, Thakore S, Mehta H, Jantz M, Parikh M, Chee A, Kaphle U, Sisnega C, Fernandez-Bussy S, Majid A. Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection. Randomized Controlled Clinical Trial. Ann Am Thorac Soc. 2020 Aug;17(8):958-964. doi: 10.1513/AnnalsATS.202001-076OC.
PubMed 32421353Mondoni M, Saderi L, Trogu F, Terraneo S, Carlucci P, Ghelma F, Centanni S, Sotgiu G. Medical thoracoscopy treatment for pleural infections: a systematic review and meta-analysis. BMC Pulm Med. 2021 Apr 20;21(1):127. doi: 10.1186/s12890-021-01492-9.
PubMed 33879116Corcoran JP, Psallidas I, Gerry S, Piccolo F, Koegelenberg CF, Saba T, Daneshvar C, Fairbairn I, Heinink R, West A, Stanton AE, Holme J, Kastelik JA, Steer H, Downer NJ, Haris M, Baker EH, Everett CF, Pepperell J, Bewick T, Yarmus L, Maldonado F, Khan B, Hart-Thomas A, Hands G, Warwick G, De Fonseka D, Hassan M, Munavvar M, Guhan A, Shahidi M, Pogson Z, Dowson L, Popowicz ND, Saba J, Ward NR, Hallifax RJ, Dobson M, Shaw R, Hedley EL, Sabia A, Robinson B, Collins GS, Davies HE, Yu LM, Miller RF, Maskell NA, Rahman NM. Prospective validation of the RAPID clinical risk prediction score in adult patients with pleural infection: the PILOT study. Eur Respir J. 2020 Nov 26;56(5):2000130. doi: 10.1183/13993003.00130-2020. Print 2020 Nov.
PubMed 32675200Maskell NA, Lee YC, Gleeson FV, Hedley EL, Pengelly G, Davies RJ. Randomized trials describing lung inflammation after pleurodesis with talc of varying particle size. Am J Respir Crit Care Med. 2004 Aug 15;170(4):377-82. doi: 10.1164/rccm.200311-1579OC. Epub 2004 May 13.
PubMed 15142871Cargill TN, Hassan M, Corcoran JP, Harriss E, Asciak R, Mercer RM, McCracken DJ, Bedawi EO, Rahman NM. A systematic review of comorbidities and outcomes of adult patients with pleural infection. Eur Respir J. 2019 Oct 1;54(3):1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep.
PubMed 31391221Davies HE, Davies RJ, Davies CW; BTS Pleural Disease Guideline Group. Management of pleural infection in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii41-53. doi: 10.1136/thx.2010.137000. No abstract available.
PubMed 20696693