Pleural EmpyemaEvACUATENCT07862361
Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
A study testing shortened antibiotic course and Standard medical treatment in people with Pleural Empyema, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pleural Empyema
- What is being tested?
- shortened antibiotic course and Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults with pleural empyema
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kameron Durante, DO contact
United States1 site
Banner University Medical Center Tucson
Tucson, Arizona, 85714
About this study
Official title: EvACUATE Trial, Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
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.
Read the detailed description
The study will be conducted as follows:
Patients will enter the hospital with evidence of pleural empyema (on blood work, imaging, etc.), this will then trigger a consultation to pulmonology or thoracic surgery. Once these patients are identified, they will be screened for enrollment. If considered appropriate for enrollment, they will be asked to consent. If consented, pulmonology, thoracic surgery, and infectious disease will follow the patients course and provide treatment recommendations when appropriate. To treat the empyema, patients will begin antibiotic treatment and either undergo drainage of the collection by chest tube, or by minimally invasive surgery. Once adequate source control is achieved which is defined by removal of chest tube(s) (either following isolated placement or placement during surgery), meaning, the collection has been adequately drained, the patients will be randomized to one of two groups:
- control group, those that receive 2-6 weeks of antibiotics following treatment
- experimental group, those that receive 7 days of antibiotics following treatment The type of antibiotic the patients receive will be determined by an infectious disease specialist. Once patients are appropriate for discharge home, they will be discharged on their remaining antibiotic course. Both groups of patients will follow up in clinic at 1 week and 4-6 weeks post-discharge. At the one-week visit they will have a pre-visit chest x-ray. At the 4-6 week visit, they will have a pre-visit CT chest. These will aid in the decision on if the patients are being adequately treated for their infection.
All workup, treatment, procedural, and follow-up patterns are current standard of care and are not experimental. The only experimental intervention is the reduction in length of antibiotic course. The type of antibiotic given does not change either based on protocol, and will be determined on a case-by-case basis based on recommendations from an infectious disease specialist. The type of drainage procedure, either chest tube or surgery, is also not experimental and will be determined by collaboration between interventional pulmonologists and thoracic surgeons, this will also be determined on a case-by-case basis as is current standard of care.
- Conditions
- Pleural Empyema
- Being tested
- shortened antibiotic course, Standard medical treatment
- Keywords
- pleural empyema, empyema, antibiotic course, antibiotic stewardship, source control
- Medical subject headings
- Empyema, Pleural, Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shortened antibiotic courseOther
this will look at shortening the course of antibiotics to 7 days from the standard 2-6 weeks
Standard medical treatmentOther
this group will receive standard course of antibiotics, 2-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | control group will receive standard antibiotic course, 2-6 weeks Receives: Other: Standard medical treatment |
| experimental | Experimental | experimental group will receive shorter antibiotic course, 7 days Receives: Other: shortened antibiotic course |
What is being measured
The primary outcome is the main question the study is designed to answer.
empyema recurrence
if the empyema recurs and requires further treatment beyond the course in the experimental or control group
Measured: from enrollment, to 3 months post randomization
Secondary outcomes (4)
readmission
if patients require readmission for further treatment from either group
Measured: from enrollment to 3 months post randomization
unplanned procedures
if patients require unplanned procedures to further treat the empyema
Measured: from enrollment to 3 months post randomization
LOS
length of stay in the hospital
Measured: from time to enrollment to discharge from the initial hospital visit
cost
a cost analysis comparing total healthcare cost/burden on each group
Measured: from time to enrollment to 3 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start16 Nov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pleural EmpyemaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one control group and one experimental group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Worrell, University of Arizona
- Investigators
- Stephanie Worrell, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862361
- Sponsor's protocol ID
- STUDY00008751
- Acronym
- EvACUATE
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is unclear if we will share IPD at this time, if the results of the study are adequate for publication (the study is able to be conducted and shows either positive or negative results), and professionals that are interested in the treatment of pleural empyema would like further clarification of IPD, we may decide to disclose this upon publication in scientific journals at the time of study conclusion
Publications
Ayala A, Majid A, Uribe JP, Paton A, Martinez R, Abdelghani R, Patel P, Chee A, Parikh M, Kheir F. ANTIBIOTIC THERAPY DURATION IN COMPLICATED PLEURAL INFECTION AND EMPYEMA. Chest, 2020, 158(4), A353 | added to CENTRAL: 30 November 2020 | 2020 Issue 11. https://doi.org/10.1016/j.chest.2020.08.350
Hassan M, Gad-Allah M, El-Shaarawy B, El-Shazly AM, Daneshvar C, Sadaka AS. The Short versus Long Antibiotic Course for Pleural Infection Management (SLIM) randomised controlled open-label trial. ERJ Open Res. 2023 Apr 11;9(2):00635-2022. doi: 10.1183/23120541.00635-2022. eCollection 2023 Mar.
PubMed 37057085Skouras V, Chatzivasiloglou F, Iliopoulou M, Rimpa T. Medical treatment of pleural infection: antibiotic duration and corticosteroid usefulness. Breathe (Sheff). 2023 Dec;19(4):230134. doi: 10.1183/20734735.0134-2023. Epub 2023 Dec 19.
PubMed 38125804
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvACUATE Trial, Evaluating Antibiotic Course Upon Adequate Treatment of Empyema
- ClinicalTrials.gov ID
- NCT07862361
- Acronym / sponsor ID
- EvACUATE / STUDY00008751
- Conditions
- Pleural Empyema
- Keywords
- pleural empyema, empyema, antibiotic course, antibiotic stewardship, source control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted as follows:
Patients will enter the hospital with evidence of pleural empyema (on blood work, imaging, etc.), this will then trigger a consultation to pulmonology or thoracic surgery. Once these patients are identified, they will be screened for enrollment. If considered appropriate for enrollment, they will be asked to consent. If consented, pulmonology, thoracic surgery, and infectious disease will follow the patients course and provide treatment recommendations when appropriate. To treat the empyema, patients will begin antibiotic treatment and either undergo drainage of the collection by chest tube, or by minimally invasive surgery. Once adequate source control is achieved which is defined by removal of chest tube(s) (either following isolated placement or placement during surgery), meaning, the collection has been adequately drained, the patients will be randomized to one of two groups:
- control group, those that receive 2-6 weeks of antibiotics following treatment
- experimental group, those that receive 7 days of antibiotics following treatment The type of antibiotic the patients receive will be determined by an infectious disease specialist. Once patients are appropriate for discharge home, they will be discharged on their remaining antibiotic course. Both groups of patients will follow up in clinic at 1 week and 4-6 weeks post-discharge. At the one-week visit they will have a pre-visit chest x-ray. At the 4-6 week visit, they will have a pre-visit CT chest. These will aid in the decision on if the patients are being adequately treated for their infection.
All workup, treatment, procedural, and follow-up patterns are current standard of care and are not experimental. The only experimental intervention is the reduction in length of antibiotic course. The type of antibiotic given does not change either based on protocol, and will be determined on a case-by-case basis based on recommendations from an infectious disease specialist. The type of drainage procedure, either chest tube or surgery, is also not experimental and will be determined by collaboration between interventional pulmonologists and thoracic surgeons, this will also be determined on a case-by-case basis as is current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- one control group and one experimental group
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: Standard medical treatmentcontrol group will receive standard antibiotic course, 2-6 weeks |
| experimental | Experimental | Other: shortened antibiotic courseexperimental group will receive shorter antibiotic course, 7 days |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults with pleural empyema
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shortened antibiotic coursethis will look at shortening the course of antibiotics to 7 days from the standard 2-6 weeks | Other | experimental |
| Standard medical treatmentthis group will receive standard course of antibiotics, 2-6 weeks | Other | control |
Primary outcome
empyema recurrence
Time frame: from enrollment, to 3 months post randomization
if the empyema recurs and requires further treatment beyond the course in the experimental or control group
4 secondary outcomes
readmission
Time frame: from enrollment to 3 months post randomization
unplanned procedures
Time frame: from enrollment to 3 months post randomization
LOS
Time frame: from time to enrollment to discharge from the initial hospital visit
cost
Time frame: from time to enrollment to 3 months post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- BackgroundAyala A, Majid A, Uribe JP, Paton A, Martinez R, Abdelghani R, Patel P, Chee A, Parikh M, Kheir F. ANTIBIOTIC THERAPY DURATION IN COMPLICATED PLEURAL INFECTION AND EMPYEMA. Chest, 2020, 158(4), A353 | added to CENTRAL: 30 November 2020 | 2020 Issue 11. https://doi.org/10.1016/j.chest.2020.08.350
- Background: PubMed 37057085Hassan M, Gad-Allah M, El-Shaarawy B, El-Shazly AM, Daneshvar C, Sadaka AS. The Short versus Long Antibiotic Course for Pleural Infection Management (SLIM) randomised controlled open-label trial. ERJ Open Res. 2023 Apr 11;9(2):00635-2022. doi: 10.1183/23120541.00635-2022. eCollection 2023 Mar.
- Background: PubMed 38125804Skouras V, Chatzivasiloglou F, Iliopoulou M, Rimpa T. Medical treatment of pleural infection: antibiotic duration and corticosteroid usefulness. Breathe (Sheff). 2023 Dec;19(4):230134. doi: 10.1183/20734735.0134-2023. Epub 2023 Dec 19.
- Individual participant dataSharing planned: Undecided. It is unclear if we will share IPD at this time, if the results of the study are adequate for publication (the study is able to be conducted and shows either positive or negative results), and professionals that are interested in the treatment of pleural empyema would like further clarification of IPD, we may decide to disclose this upon publication in scientific journals at the time of study conclusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kameron Durante, DO contact
Stephanie Worrell, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shortened antibiotic course and Standard medical treatment in people with Pleural Empyema, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Worrell, MD (520-621-1857, sworrell@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
empyema recurrence (time frame: from enrollment, to 3 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07862361, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.