CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Short course (2-3 weeks) of antibiotics +1 moreother
Likely dose
Not stated in record
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Search/NCT04615286
NCT04615286N/ACompleted

Short Versus Long Antibiotic Course for Pleural Infection Management (SLIM Trial): a Randomized Controlled Open Label Trial

Alexandria University·interventional·Posted Nov 4, 2020·Updated Dec 21, 2021

In Brief

A clinical study evaluating Short course (2-3 weeks) of antibiotics and Standard (long course) of antibiotics for Pleural Infection. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 4, 2020
Enrollment StartSep 28, 2020
Primary CompletionNov 10, 2021
Study CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago

Interventions

Short course (2-3 weeks) of antibioticsother

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

Standard (long course) of antibioticsother

4-6 weeks of antibiotics