Two vs. three weeks of treatment with amoxicillin-clavulanate for stabilized community-acquired complicated parapneumonic effusions. A preliminary non-inferiority, double-blind, randomized, controlled trial.
amoxicillin-clavulanate
community-acquired pneumonia
empyema
parapneumonic effusion
pleural effusion
Journal
Pleura and peritoneum
ISSN: 2364-768X
Titre abrégé: Pleura Peritoneum
Pays: Germany
ID NLM: 101710063
Informations de publication
Date de publication:
01 Mar 2020
01 Mar 2020
Historique:
received:
11
10
2019
accepted:
17
12
2019
entrez:
16
9
2020
pubmed:
17
9
2020
medline:
17
9
2020
Statut:
epublish
Résumé
The optimal duration of antibiotic treatment for complicated parapneumonic effusions (CPPEs) has not been properly defined. Our aim was to compare the efficacy of amoxicillin-clavulanate for 2 vs. 3 weeks in patients with CPPE (i.e. those which required chest tube drainage). In this non-inferiority, randomized, double-blind, controlled trial, patients with community-acquired CPPE were recruited from two centers in Spain and, after having obtained clinical stability following 2 weeks of amoxicillin-clavulanate, they were randomly assigned to placebo or antibiotic for an additional week. The primary objective was clinical success, tested for a non-inferiority margin of<10%. Secondary outcomes were the proportion of residual pleural thickening of>10 mm at 3 months, and adverse events. The study was registered with EudraCT, number 2014-003137-25. We originally planned to randomly assign 284 patients. After recruiting 55 patients, the study was terminated early owing to slow enrolment. A total of 25 patients were assigned to 2 weeks and 30 patients to 3 weeks of amoxicillin-clavulanate. Clinical success occurred in the 25 (100%) patients treated for 2 weeks and 29 (97%) treated for 3 weeks (difference 3%, 95% CI -3 to 9.7%). Respective between-group differences in the rate of residual pleural thickening (-12%, 95%CI -39 to 14%) and adverse events (-7%, 95%CI -16 to 2%) did not reach statistical significance. In this small series of selected adult patients with community-acquired CPPE, amoxicillin-clavulanate treatment could be safely discontinued by day 14 if clinical stability was obtained.
Sections du résumé
BACKGROUND
BACKGROUND
The optimal duration of antibiotic treatment for complicated parapneumonic effusions (CPPEs) has not been properly defined. Our aim was to compare the efficacy of amoxicillin-clavulanate for 2 vs. 3 weeks in patients with CPPE (i.e. those which required chest tube drainage).
METHODS
METHODS
In this non-inferiority, randomized, double-blind, controlled trial, patients with community-acquired CPPE were recruited from two centers in Spain and, after having obtained clinical stability following 2 weeks of amoxicillin-clavulanate, they were randomly assigned to placebo or antibiotic for an additional week. The primary objective was clinical success, tested for a non-inferiority margin of<10%. Secondary outcomes were the proportion of residual pleural thickening of>10 mm at 3 months, and adverse events. The study was registered with EudraCT, number 2014-003137-25. We originally planned to randomly assign 284 patients.
RESULTS
RESULTS
After recruiting 55 patients, the study was terminated early owing to slow enrolment. A total of 25 patients were assigned to 2 weeks and 30 patients to 3 weeks of amoxicillin-clavulanate. Clinical success occurred in the 25 (100%) patients treated for 2 weeks and 29 (97%) treated for 3 weeks (difference 3%, 95% CI -3 to 9.7%). Respective between-group differences in the rate of residual pleural thickening (-12%, 95%CI -39 to 14%) and adverse events (-7%, 95%CI -16 to 2%) did not reach statistical significance.
CONCLUSIONS
CONCLUSIONS
In this small series of selected adult patients with community-acquired CPPE, amoxicillin-clavulanate treatment could be safely discontinued by day 14 if clinical stability was obtained.
Identifiants
pubmed: 32934974
doi: 10.1515/pp-2019-0027
pii: pp-pp-2019-0027
pmc: PMC7469502
doi:
Types de publication
Journal Article
Langues
eng
Pagination
20190027Informations de copyright
© 2020 Porcel et al., published by De Gruyter.
Déclaration de conflit d'intérêts
Competing interests: The funding organization played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Références
J Infect. 2016 May;72(5):537-43
pubmed: 26987740
Ann Intern Med. 2019 Aug 6;171(3):153-163
pubmed: 31284301
Chest. 2015 Sep;148(3):e102-e103
pubmed: 26324137
Eur Respir J. 2019 Oct 1;54(3):
pubmed: 31248959
Ann Rheum Dis. 2019 Aug;78(8):1114-1121
pubmed: 30992295
Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67
pubmed: 31573350
Eur Respir J. 2003 Jun;21(6):952-5
pubmed: 12797487
Respirology. 2019 Feb;24(2):171-178
pubmed: 30187976
Eur Respir J. 2011 Nov;38(5):1173-9
pubmed: 21565916
Basic Clin Pharmacol Toxicol. 2019 May;124(5):550-559
pubmed: 30694600
Clin Respir J. 2018 Apr;12(4):1361-1366
pubmed: 29087029
Arch Bronconeumol. 1999 Mar;35(3):108-12
pubmed: 10216741
Chest. 2014 Apr;145(4):848-855
pubmed: 24264558
N Engl J Med. 2011 Aug 11;365(6):518-26
pubmed: 21830966
Gen Thorac Cardiovasc Surg. 2019 Dec;67(12):1048-1055
pubmed: 31054144
Lung. 2015 Dec;193(6):993-1000
pubmed: 26423784
Thorax. 2010 Aug;65 Suppl 2:ii41-53
pubmed: 20696693
Lung. 2017 Feb;195(1):135-138
pubmed: 27866276
J Thorac Cardiovasc Surg. 2017 Jun;153(6):e129-e146
pubmed: 28274565