Acute respiratory infection, pleural infection Respiratory Acute respiratory infection, pleural infection
Conditions
Interventions
Participants will be approached initially by the clinical team as in-patients, who are suspected of having pleural infection. The aim is to enrol all participants with pleural infection and then asses
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/03/2021: 1. A clinical presentation compatible with pleural infection AND 2. A pleural collection with a chest drain in situ 3. Has pleural fluid requiring drainage which is either: 3.1 Purulent or 3.2 Gram stain positive or 3.3 Culture positive or 3.4 Acidic with a pH < 7.2 or 3.5 Low pleural fluid glucose (< 2mmol / L) in the absence of accurate pH measurement or 4. Residual collection/ongoing sepsis after 24h standard care 5. Willing and able to give written informed consent _____ Previous inclusion criteria: 1. A clinical presentation compatible with pleural infection AND 2. Has pleural fluid requiring drainage which is either: 2.1 Purulent or 2.2 Gram stain positive or 2.3 Culture positive or 2.4 Acidic with a pH < 7.2 or 2.5 Low pleural fluid glucose (< 2mmol / L) in the absence of accurate pH measurement or 2.6 Septated pleural fluid on ultrasound which is likely secondary to pleural infection (on the basis of local investigator view). 3. Able to give written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 02/03/2021: 1. Age = 72 hours 4. Has previously received intra-pleural fibrinolytics and /or DNase for this empyema 5. Has a known sensitivity to DNase or tissue plasminogen activator 6. Has had a previous pneumonectomy on the side of infection 7. Pregnant or lactating 8. Estimated survival less than three months from a different pathology to this empyema, (e.g. metastatic lung carcinoma) _____ Previous exclusion criteria: 1. Age < 18 years 2. Previously received intra-pleural fibrinolytics and /or DNase for this empyema 3. Known sensitivity to DNase or tissue plasminogen activator 4. Previous pneumonectomy on the side of infection 5. Pregnant or lactating 6. Estimated survival less than three months from a different pathology to this empyema, (e.g. metastatic lung carcinoma)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of randomising 75 participants with pleural infection to standard care, early VATS or early IET, assessed using: 1. Recruitment rate 2. Retention rate and the proportion of participants screened 3. Who consented to be randomised 4. Who consented to be interviewed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The risks/benefits from a participant/carer perspective of a referral to standard care, VATS or IET treatment strategy as well as which outcomes of pleural infection are most important to the participants assessed by performing structured qualitative interviews with a selection of participants who have had pleural infection and their carers (carer interviews at Oxford recruiting site only) 2. The acceptability of randomisation in a surgery versus non-surgery trial assessed by proportion of participants who accepted/did not accept to be randomised. Conduct structured interviews with all groups of participants to collect information about their concerns and reasons for accepting/not accepting randomisation 3. Feasibility of collecting accurate long-term outcomes assessed by completeness of data collected over 6 months from randomisation, regarding mortality, length of hospital stay (time from starting intervention until discharge), number of hospital readmissions, completion of lung function tests (FEV1/FVC), proportion of participants requiring further surgery. Assess the number of qualitative assessments completed such as functional assessments, questionnaires and visual analogue scores. Collect data on quality of life 4. Feasibility of trial interventions assessed by recording type of surgery (VATS, thoracotomy) and time surgery (from randomisation to surgery point of surgical intervention) in the surgical arm and details of compliance (proportion initiating treatment/completing treatment/requiring dose reductions/missed doses) in each interventional arm along with the reasons for non-completion 5. Costs of surgery will be assessed using a micro-costing study evaluating staff time, theatre time and consumables. Other healthcare resource use will be obtained from participants’ trial records; hospital records; and participant self-report through questionnaires. Resource use will be cos | — |
Countries
England, United Kingdom
Outcome results
None listed