Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
ConditionPleural Empyema
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Arizona
About this trial
The study compares treatment strategies for treatment of pleural empyema (infected fluid in the chest). It will compare standard of care antibiotic course, 2-6 weeks, to a shorter course of antibiotics, 7 days. This course is started once patients achieve adequate source control/drainage of the infected fluid collection. All other treatments and interventions in patients such as blood work, imaging, vitals, and surgery/procedures follows current standard of care and are not experimental.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adults with pleural empyema
Disqualifiers
Subjects must not be, younger than 18 or older than 99 years of age, have ongoing evidence of fungal infection, tuberculosis, malignant effusions or cancer involving the lungs/pleura, pregnancy, immunocompromised patients, & patients with concurrent secondary infections requiring additional antibiotic therapy
Trial design
Design model
Parallel
Treatments tested in this trial
shortened antibiotic course
Other interventionthis will look at shortening the course of antibiotics to 7 days from the standard 2-6 weeks
Standard medical treatment
Other interventionthis group will receive standard course of antibiotics, 2-6 weeks
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: controlActive comparator 1 intervention
Group B: experimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
empyema recurrence
if the empyema recurs and requires further treatment beyond the course in the experimental or control group
Time frame
from enrollment, to 3 months post randomizationSecondary outcomes
1
readmission
if patients require readmission for further treatment from either group
Time frame
from enrollment to 3 months post randomization2
unplanned procedures
if patients require unplanned procedures to further treat the empyema
Time frame
from enrollment to 3 months post randomization3
LOS
length of stay in the hospital
Time frame
from time to enrollment to discharge from the initial hospital visit4
cost
a cost analysis comparing total healthcare cost/burden on each group
Time frame
from time to enrollment to 3 months post enrollmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: