[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658998":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":39,"overallOfficials":18,"centralContacts":50,"locations":18,"responsibleParty":56,"collaborators":60,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":88,"whyStopped":18,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":18},{"fullName":5,"class":6},"Alexandria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Length of hospital stay","Duration of initial hospital stay","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",[14],{"measure":15,"description":16,"timeFrame":17},"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","Duration of recording of the outcome will be from randomisation to 30 days after that day",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","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.\n\nThe 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.\n\nThe 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.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Medical thoracoscopy","EXPERIMENTAL","Patients with pleural infection receiving standard of care treatment plus medical thoracoscopy",[32],"Procedure: Medical thoracoscopy plus standard of care",{"label":34,"type":35,"description":36,"interventionNames":37},"Standard of care arm","ACTIVE_COMPARATOR","Patients with pleural infection receiving standard of care treatment",[38],"Drug: Standard of Care (Investigator Choice)",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":18},"PROCEDURE","Medical thoracoscopy plus standard of care","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.",[28],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":18},"DRUG","Standard of Care (Investigator Choice)","This will include antibiotics, venous thromboprophylaxis and intrapleural therapy.",[34],[51],{"name":52,"role":53,"phone":54,"phoneExt":18,"email":55},"Maged Hassan, PhD","CONTACT","+201289549083","maged.mahmoud@alexmed.edu.eg",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Maged Hassan","Assistant Professor of Chest Diseases",[61,63,65],{"name":62,"class":6},"Assiut University",{"name":64,"class":6},"Mansoura University",{"name":66,"class":6},"Ain Shams University","100658998","study-of-medical-thoracoscopy-in-early-pleural-infection-100658998",false,"NCT07858721","Study of Medical Thoracoscopy in Early Pleural Infection","Study of Medical Thoracoscopy in Early Pleural Infection (STEP) - a Multicentre Randomised Controlled Trial","STEP","Inclusion Criteria:\n\n* Adult patients (\\>18 years old)\n* Willing to provide informed consent\n* 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\\]:\n\n  1. the presence of pus in the pleural space;\n  2. positive pleural fluid gram stain or culture; or\n  3. pleural fluid pH \\\u003C 7.2 or pleural fluid glucose \\\u003C 40 mg\u002FdL (in the setting of acute respiratory infection)\n  4. pleural fluid pH 7.21-7.39 with LDH \\>900 IU\u002FL with pleural fluid glucose \\\u003C72 mg\u002FdL, pleural fluid septation in ultrasound, or pleural enhancement on CT (in the setting of acute respiratory infection)\n\nExclusion Criteria:\n\n* Inability to undergo medical thoracoscopy within 72 hours of diagnosis confirmation\n* Suspected or proven tuberculous aetiology for the pleural effusion\n* 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\n* insertion site)\n* Ipsilateral pleural infection within the last three months from presentation\n* Previous ipsilateral thoracic surgery\n* Evidence of chronic pleural infection on clinical or radiological basis (stage III, organizing phase)\n* Pleural effusion not amenable to chest drain insertion\u002Fmedical thoracoscopy due to location (medial or posterior loculation) or size (depth \\\u003C2cm)\n* Pregnancy","ALL","18 Years",{"count":78,"type":79},128,"ESTIMATED","INTERVENTIONAL",[82],"NA","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.\n\nThere 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.\n\nThe 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.",[85],"Pleural Infection",[87],"medical thoracoscopy","NOT_YET_RECRUITING","2026-10-01",{"date":91,"type":92},"2026-10-05","ACTUAL",{"date":94,"type":79},"2026-11-01",{"date":96,"type":79},"2029-04-30",{"name":5,"class":6}]