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Complicated Parapneumonic EffusionPhase 4FLONCT07592520

Flush, Lyse, Operate

A Phase 4 study testing Intrapleural Saline with possible escalation to intraplerual alteplase and dornase. in people with Complicated Parapneumonic Effusion and Empyema, Pleural, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to learn if saline results in improvement for patients with infection of their plerual space. The main question it aims to answer is: What is the time to chest tube removal? Do these patients after need to escalate to fibrinolytics? Do these patients after need to escalate to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intrapleural Saline with possible escalation to intraplerual alteplase and dornase.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Apr 2026to Apr 2027
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18+
  • Complicated Parapneumonic Effusion or Empyema Requiring Thoracostomy
  • Are able to personally or have a designated medical decision maker provide consent

Who cannot join

  • Age < 18 years
  • Have received any intrapleural medications prior to enrolment via current chest tube
  • Have a contraindication to tPA/DNase:
  • Anticoagulation
  • Active hemorrhage
  • Allergy to tPA/DNase
  • Pregnancy
  • Are unable to personally or do not have a designated medical decision maker provide consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Dartmouth-Hitchcock Medical Center

    Hanover, New Hampshire, 03756

    Adele E Soutar, MD, 603-650-5000, adele.e.soutar@hitchcock.org

    Jimmy Wang, MD

Other trials in United States

About this study

Official title: Flush, Lyse, Operate: A Pilot Trial of Step-Wise Escalation for Pleural Infection: FLO Trial

The goal of this observational study is to learn if saline results in improvement for patients with infection of their plerual space. The main question it aims to answer is:

What is the time to chest tube removal? Do these patients after need to escalate to fibrinolytics? Do these patients after need to escalate to surgery?

Read more

Participants will:

  • Receive receive saline into their pleural space through an existing chest tube
  • If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will receive fibrynolytics through an existing chest tube
  • If they fail to improve, which will be determined by fluid size after treatment or signs of persistent infection, they will be referred to surgery.
Read the detailed description

Patients who require a chest tube for complicated parapneumonic effusion or empyema who meet inclusion criteria and consent, will be enrolled. An ultrasound measurement of the original effusions prior to chest tube placement will be obtained then chest tube insertion will follow as well as an additional US measurement once placed. After appropriate positioning is confirmed, there will be instillation of intrapleural saline and will be administered every 8 hours for a total of 3 days. After completion of the intrapleural saline course, the effusion will be remeasured by ultrasound. Should the effusions fail to reduce by 75% or significant septations remain, the patient will then be escalated to intrapleural tPA/DNase which will be administered every 12 hours for 3 days. After the completed course of tPA/DNase, a US will be performed, and if significant fluid remains, >50% of the original effusion or septations remain, Thoracic Surgery consultation will be placed for discussion of VATs.

Being tested
Intrapleural Saline with possible escalation to intraplerual alteplase and dornase.
Medical subject headings
Empyema, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrapleural Saline with possible escalation to intraplerual alteplase and dornase.Drug

    Also called normal saline, alteplase, dornase alfa

    Though intraplerual alteplase/ dornase alfa and normal saline have been established method to reduce complicated pleural infection sizes and rate of surgical interventions, with tPA/DNAse being the gold standards, there has not been a study comparing the two head to head. This trial's purpose is to function as pilot study as a foundation for a potential noninferiorrity trail comparing the two.

Study groups in NCT07592520
Study groupRoleWhat they receive
Intraplerual SalineOtherAll patients will be in a single arm and escalated from intraplerual saline to tPA/DNAse followed by surgery as warranted based on protocol criteria.
Receives: Drug: Intrapleural Saline with possible escalation to intraplerual alteplase and dornase.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to chest tube removal

    measuring the length of time from chest tube insertion to removal

    Measured: From enrollment to removal- estimated up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days.

Secondary outcomes (5)

  1. Need for escalation to fibrinolytics

    Rate of patients requiring intraplerual tPA/DNAse after completion of intrapleural saline

    Measured: From enrollment to chest tube removal- up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days.

  2. Need for escalation to Video-assisted thoracic surgery (VATS)

    Evaluation fo patients who require Video-assisted thoracic surgery (VATS) after completion of intraplerual saline and tPA/DNAse

    Measured: From enrollment to chest tube removal- up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and 3 days for intrapleural fibrinolytics, therefore VATs determined after, about 7 days.

  3. Rate of hemothorax.

    Evaluating number of patients who develop a hemothorax

    Measured: From enrollment to chest tube removal- up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days.

  4. Length of Hospital Stay

    Quantifying the length of hospital stay for all patients enrolled

    Measured: From enrollment to discharge- up to 52 weeks.

  5. Mortality

    Rate of 30 day all cause mortally

    Measured: 30 days from enrollment: rate of documented death prior or up to 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592520
Sponsor's protocol ID
STUDY02003106
Acronym
FLO
Status last verified
May 2026
First submitted
31 Mar 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hassan M, Rizk R, Essam H, Abouelnour A. Validation of equations for pleural effusion volume estimation by ultrasonography. J Ultrasound. 2017 Oct 27;20(4):267-271. doi: 10.1007/s40477-017-0266-1. eCollection 2017 Dec.

    PubMed 29204230

  • Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

    PubMed 23961782

  • Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

    PubMed 26092476

  • Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.

    PubMed 26022948

  • Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.

    PubMed 21830966

  • Maskell NA, Davies CW, Nunn AJ, Hedley EL, Gleeson FV, Miller R, Gabe R, Rees GL, Peto TE, Woodhead MA, Lane DJ, Darbyshire JH, Davies RJ; First Multicenter Intrapleural Sepsis Trial (MIST1) Group. U.K. Controlled trial of intrapleural streptokinase for pleural infection. N Engl J Med. 2005 Mar 3;352(9):865-74. doi: 10.1056/NEJMoa042473.

    PubMed 15745977

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intrapleural Saline with possible escalation to intraplerual alteplase and dornase. in people with Complicated Parapneumonic Effusion and Empyema, Pleural, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 8 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 18 May 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to chest tube removal (time frame: From enrollment to removal- estimated up to 7 days. Once chest tube is placed, it will take 3 days for saline course to be completed and, if escalated, 3 days for intrapleural fibrinolytics, therefore may not be removed until after 7 days.). 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 NCT07592520, which also lists 6 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 18 May 2026.

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