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.

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: 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: 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: 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.

[Protocolisation of parenteral artificial nutrition: Methodological and organisational bases for process design and review]. / Protocolización de la Nutrición Artificial por vía Parenteral: Bases metodológicas y organizativas para el diseño y revisión del proceso.

In the field of parenteral artificial nutrition (PN) there is debate over the application of such concepts as standardisation, individualisation, protocolisation and normalisation. Artificial Nutrition Units (ANU) that are designing or reviewing their PN provision system must take into account the existing methodological and regulatory references as well as the resources available for implementing the process. The aim of this article is to review and evaluate the possibilities that exist for designing an efficient, safe process, applying the methodology of continuous quality improvement. Current requirements are reviewed in terms of quality of formulation, safety, and cost containment, as well as the resources available to avoid jeopardising the possibilities of adapting the treatment to suit patient needs or compromising its efficacy. The solution to the problem of whether the chosen approach in the system of PN provision is appropriate must come from review of the quality of service through the evaluation of indicators both of process and results. In this task, the hospital pharmacist plays a significant role as an agent in guaranteeing compliance with good practice guidelines.