NCT04615286: SLIM

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

Completed NA Last updated 21 December 2021

What this trial tests

NA trial testing Short course (2-3 weeks) of antibiotics in Pleural Infection in 50 participants. Completed in 6 December 2021.

Timeline

28 September 2020

Primary endpoint
10 November 2021

6 December 2021

Quick facts

Lead sponsor	Alexandria University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	28 September 2020
Primary completion	10 November 2021
Estimated completion	6 December 2021
Sites	1 location across Egypt

Drugs / interventions tested

• Short course (2-3 weeks) of antibiotics
• Standard (long course) of antibiotics

Conditions studied

• Pleural Infection — all drugs for Pleural Infection →

Sponsor

Alexandria University

Who can join

18 and older, any sex, with Pleural Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Insights into the Management of Pleural Infection.
   Hassan M, Patel S, Sadaka AS, Bedawi EO, et al · · 2021 · cited 27× · PMID 34290522 · DOI 10.2147/ijgm.s292705
2. The Short <i>versus</i> Long Antibiotic Course for Pleural Infection Management (SLIM) randomised controlled open-label trial.
   Hassan M, Gad-Allah M, El-Shaarawy B, El-Shazly AM, et al · · 2023 · cited 10× · PMID 37057085 · DOI 10.1183/23120541.00635-2022
3. From Chest Wall Resection to Medical Management: The Continued Saga of Parapneumonic Effusion Management and Future Directions.
   Santoshi RK, Chandar P, Gupta SS, Kupfer Y, et al · · 2022 · cited 3× · PMID 35018275 · DOI 10.7759/cureus.21017
4. The Short versus Long antibiotic course for pleural Infection Management (SLIM) randomised controlled open label trial
   Hassan M, Gad-Allah M, El-Shaarawy B, El-Shazly AM, et al · · 2022 · DOI 10.21203/rs.3.rs-1678114/v1