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Short Versus Long Antibiotic Course for Pleural Infection Management (SLIM Trial)

NCT04615286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-12-21

No results posted yet for this study

Summary

Infection of the pleural space is serious condition that requires hospitalization, invasive interventions and long courses of antibiotics\[1\]. Treatment of pleural infection requires long hospital admission with a median of 19 days\[2\] and medical treatments fails requiring surgical intervention in up to 30% of cases\[3\]. The mortality from pleural infection is around 10% at 3 months\[4\].

Besides drainage of the infected fluid, antibiotics are a core component of management of pleural infection\[5\] and are typically given intravenously in the first few days of treatment until the condition is stabilized at which stage patients are shifted to oral antibiotics of equivalent spectrum. In almost half of the cases of pleural infection, the choice of antibiotics is entirely empirical due to low yield of microbiological tests on pleural fluid in these cases\[6\]. International guidelines cite a minimum length of antibiotic course of pleural infection of four weeks\[5,7\] with antibiotic courses typically lasting six weeks\[8\]. However, these recommendations are based on expert opinion with no robust evidence to support such durations.

The RAPID (renal function, age, purulence, infection source and dietary factors) score has recently been validated as a robust tool to predict 3-month mortality of patients with pleural infection based on demographic and laboratory data (table 1)\[4\]. A low score (0-2) is associated with 2-3% mortality, medium score (3-4) 9% mortality and high score (5-7) 30% mortality at three months\[9\]. The utility for this score in clinical management is yet to be determined and this study will attempt using this score to stratify lengths of antibiotic treatment based on proposed risk of adverse outcomes as stipulated by the RAPID score.

The aim of this study is to investigate the feasibility and safety of prescribing shorter courses of antibiotics (2-3 weeks) versus the standard longer courses (4-6 weeks) in medically-treated patients with pleural infection at lower risk of mortality (RAPID score 0-4) who can be safely discharged home within 14 days of hospitalization and how this impacts success of medical treatment.

Conditions

  • Pleural Infection

Interventions

OTHER

Short course (2-3 weeks) of antibiotics

Shorter course of antibiotic than standard care of 4-6 weeks

OTHER

Standard (long course) of antibiotics

4-6 weeks of antibiotics

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Maged Hassan, PhD · Alexandria University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2021-11-10
Completion
2021-12-06

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04615286 on ClinicalTrials.gov