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The Pleural Infection Longitudinal Outcome Study

The Pleural Infection Longitudinal Outcome Study: an observational cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN50236700
Enrollment
550
Registered
2013-05-20
Start date
2013-05-01
Completion date
Unknown
Last updated
2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Infection Respiratory Pleural condition, unspecified

Interventions

Demographics, details of clinical history and past medical history, drug history including antibiotic use within the last 4 weeks and baseline clinical observations, as recorded in normal clinical car

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients, both male and female, aged 18 years or over with pleural infection as diagnosed by standard and internationally-accepted criteria as follows: 1. A clinical presentation compatible with pleural infection, AND 2. A pleural fluid collection that may or (rarely, according to clinical judgement) may not require drainage that meets at least one or more of the following criteria: 2.1. Purulent 2.2. Gram stain positive for bacteria 2.3. Bacterial culture positive 2.4. Acidic with a pH <7.2 2.5. Low pleural fluid glucose <3mmol/L (<40mg/dL) 2.6. CT evidence of pleural infection (consolidation of underlying lung with enhancing pleural collection on contrast-enhanced CT)

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. No pleural fluid available for analysis 3. Previous pneumonectomy on the side of pleural infection 4. Expected survival <3 months due to co-morbid disease 5. Inability to give informed consent

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the capability of the prediction score (RAPID) to predict mortality from pleural infection at 3 months. The PILOT study is intended to ascertain the capacity of baseline clinical and biological parameters and an associated prediction model (RAPID score) to predict key clinical outcomes including mortality from pleural infection. These include renal indices, age, purulence of pleural fluid, infection source and albumin measured at baseline.

Secondary

MeasureTime frame
The secondary outcomes of this study are the capability of baseline clinical indices and the prediction score (RAPID) to predict the following: 1. Mortality from pleural infection at 12 months 2. Duration of hospital (in-patient) stay 3. Necessity for surgical fluid drainage over 12 months 4. Failure of medical treatment 5. Residual lung function impairment at 3 months

Countries

Australia, Belgium, Singapore, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026