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 Abstract 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, doubleblind, 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, amoxicillinclavulanate treatment could be safely discontinued by day 14 if clinical stability was obtained.
Background
Sponsors of clinical trials (CTs) provide information for patients about the objective of the trial, describe the treatment and alternatives and answer other related questions.
Purpose
To evaluate the information provided to patients by the CT sponsors and to assess the need to develop a complementary information form.
Materials and methods
A cross-sectional, descriptive study was conducted during August 2011. The informed consent, patient information forms (PIFs) and patient diaries were reviewed. In these documents the quality of the following items was checked: a) Posology: high (description of the dose, allowed delays and route of administration), medium (only refers to the dose) and low (no references or details about drug information). b) Adverse events (AE): information present or not. c) Interactions with the study drug. Documents were divided in those that were detailed and those that did not give any information.
Results
At the time of analysis there were 104 active trials. In 35 (33.7%) the pharmacist dispensed the investigational oral drug to patients. In all trials a PIF was provided, in 15 (42.9%) patients had an identity card and in 13 (37.1%) a diary. Regarding to the type and quality of the information contained in these documents it was found that the dose schedule and route of administration were described in all the CTs. However only in 24 (68.6%) of trials was the quality of information about the posology high, in 6 medium (17.1%) and in 5 low (14.3%). AEs were described in all the documents reviewed but the interacting drugs were specified only in 19 (54.3%) of them.
Conclusions
The information provided by the sponsors is in some cases deficient or confusing. For this reason the clinical trials department of the pharmacy department decided to make a complementary information form which will contain: simplified information about the dose schedule, route of administration, storage and how to contact the pharmacy.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.