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Empyema, PleuralPhase 2RINSENCT05546762

Trial of Antiseptic Irrigation for Pleural Infection

A Phase 2 study testing Povidone-iodine solution and Normal saline in people with Empyema, Pleural, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pleural antiseptic irrigation (PAI) is used in conjunction with open drainage for treating adults with chronic post-thoracotomy empyema. The antiseptic povidone-iodine can safely be instilled into the pleural cavity for the purpose of pleurodesis and has recently been described for pleural irrigation in the acute… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Empyema, Pleural
What is being tested?
Povidone-iodine solution and Normal saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteEgypt
Study dates
19 Sep 2022to 1 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 (18 year-old or more)
  • Pleural infection diagnosed by: the presence of pus in the pleural space, OR any of the following in the setting of acute lower-respiratory tract infection symptoms: pleural fluid PH<7.2 or pleural fluid glucose <40 mg/dL, positive gram stain or culture from pleural fluid
  • Predominantly unilocular pleural collection treated with chest tube drainage
  • Acute response at presentation as evidenced by fever (>37.80C) and/or blood leucocytosis (>11X103/mm3) and/or high serum C-reactive protein, CRP (>50 mg/L)

Who cannot join

  • Known or suspected thyroid disease
  • Allergy to iodine
  • Persistent large collection on follow-up imaging 24-48 post tube insertion that is deemed to require additional interventions (e.g., another drainage procedure, intrapleural fibrinolytic)
  • Evidence or suspicion of broncho-pleural fistula (suspected when there is air-fluid level without previous intervention, or if the participant is coughing large volume of purulent sputum that is physically similar to drained pleural fluid)
  • Tuberculous, post-operative or post-haemothorax pleural infections

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Alexandria University Faculty of Medicine

    Alexandria

Other trials in Egypt

About this study

Official title: IrRigation of the INfected Pleural Space With antiSEptic Solution (RINSE) - a Proof of Concept Study

Pleural antiseptic irrigation (PAI) is used in conjunction with open drainage for treating adults with chronic post-thoracotomy empyema. The antiseptic povidone-iodine can safely be instilled into the pleural cavity for the purpose of pleurodesis and has recently been described for pleural irrigation in the acute management of paediatric pleural infection with good outcomes. A recent case report demonstrated the safe use of povidone-iodine pleural irrigation in a patient with complex pleural empyema with successful medical management. In a previous pilot study, antiseptic irrigation led to less referral to surgery and shorter length of hospital stay in comparison to no irrigation.

This study aims to investigate the effect of antiseptic pleural irrigation (using povidone iodine) on the inflammatory response in adults patients with pleural infection in comparison to irrigation with normal saline alone. A reduction in the systemic inflammatory response can be inferred to correlate with reduction in the infection burden in the pleural space.

Being tested
Povidone-iodine solution, Normal saline
Medical subject headings
Empyema, Pleural

What participants receive

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

  • Povidone-iodine solutionDrug

    Pleural irrigation with 2% povidone iodine

  • Normal salineDrug

    Pleural irrigation with normal saline

Study groups in NCT05546762
Study groupRoleWhat they receive
Antiseptic irrigation armExperimental250 ml solution of 2% povidone-iodine (i.e. 50 ml betadine in 200 ml saline) will be attached to the chest tube via a giving set and a 3-way tap and irrigated into the pleural space with gravity. The chest tube will be clamped for 10-20 minutes after irrigation and then will be unclamped and left to drain freely. The first dose will be applied 24-48 hours after tube insertion. This will be repeated every 12 hours for a total of four to six applications.
Receives: Drug: Povidone-iodine solution
Saline irrigation armActive comparator250 ml solution of normal saline will be attached to the chest tube via a giving set and a 3-way tap and irrigated into the pleural space with gravity. The chest tube will be clamped for 10-20 minutes after irrigation and then will be unclamped and left to drain freely. The first dose will be applied 24-48 hours after tube insertion. This will be repeated every 12 hours for a total of four to six applications.
Receives: Drug: Normal saline

What is being measured

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

  1. Percentage change in inflammatory markers before and after irrigation

    The percentage by which inflammatory marker (CRP and/or procalcitonin) decrease after completing all irrigations in comparison to the pre-irrigation inflammatory markers level

    Measured: Initial levels to be measured 12 to 48 hours post tube insertion and follow up levels 12 to 24 hours post last dose of irrigation

Secondary outcomes (5)

  1. Time in days to chest tube removal

    The time in days from the first irrigation to the chest tube removal

    Measured: At the time of chest tube removal (up to 6 weeks)

  2. Total length of hospital stay in days

    Duration of hospital stay from admission until a patient is declared medically fit for discharge

    Measured: At the point of deciding a patient is medically fit for discharge (assessed up to 6 weeks)

  3. Percentage of radiological clearance between baseline and discharge chest X-rays

    Percentage of radiological clearance of pleural abnormalities between baseline and discharge chest X-rays using a computer software

    Measured: baseline and discharge (up to week 6)

  4. Incidence of medical treatment failure

    Number of patients who fail medical treatment (referral to surgery, further pleural procedures or death)

    Measured: At discharge from the hospital or referral to another department (assessed up to week 6)

  5. Incidence of adverse events

    Number of patients with different types of adverse events

    Measured: Adverse events will be recognised if they appear within 6 hours of a given irrigation procedure

Timeline

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

  1. First posted21 Sep 2022
  2. Study start19 Sep 2022
  3. Primary completion1 Apr 2024
  4. Study completion1 May 2024

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546762
Sponsor's protocol ID
02/24/09/2022
Acronym
RINSE
Status last verified
Jun 2026
First submitted
11 Sep 2022
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: These spreadsheet with individual participant data will be stored after trial conclusion with the principal investigator and will be accessible to other members of the study team. Request to access study data by other researchers will be expected via email and access will be granted by the principal investigator if the request is deemed reasonable.

Publications

  • Cargill TN, Hassan M, Corcoran JP, Harriss E, Asciak R, Mercer RM, McCracken DJ, Bedawi EO, Rahman NM. A systematic review of comorbidities and outcomes of adult patients with pleural infection. Eur Respir J. 2019 Oct 1;54(3):1900541. doi: 10.1183/13993003.00541-2019. Print 2019 Sep.

    PubMed 31391221

  • Sogaard M, Nielsen RB, Norgaard M, Kornum JB, Schonheyder HC, Thomsen RW. Incidence, length of stay, and prognosis of hospitalized patients with pleural empyema: a 15-year Danish nationwide cohort study. Chest. 2014 Jan;145(1):189-192. doi: 10.1378/chest.13-1912. No abstract available.

    PubMed 24394842

  • Mummadi SR, Stoller JK, Lopez R, Kailasam K, Gillespie CT, Hahn PY. Epidemiology of Adult Pleural Disease in the United States. Chest. 2021 Oct;160(4):1534-1551. doi: 10.1016/j.chest.2021.05.026. Epub 2021 May 20.

    PubMed 34023322

  • 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

  • Muthu V, Dhooria S, Sehgal IS, Prasad KT, Aggarwal AN, Agarwal R. Iodopovidone pleurodesis for malignant pleural effusions: an updated systematic review and meta-analysis. Support Care Cancer. 2021 Aug;29(8):4733-4742. doi: 10.1007/s00520-021-06004-3. Epub 2021 Jan 30.

    PubMed 33515303

  • Elhoffy A, Amin A, Sadaka AS, Hassan M. Management of a complex thoracic infection, one compartment at a time. Thorax. 2022 Apr;77(4):417-419. doi: 10.1136/thoraxjnl-2021-218475. Epub 2022 Jan 17. No abstract available.

    PubMed 35039443

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Povidone-iodine solution and Normal saline in people with Empyema, Pleural, run by Alexandria University at 1 site in Egypt.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jun 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in inflammatory markers before and after irrigation (time frame: Initial levels to be measured 12 to 48 hours post tube insertion and follow up levels 12 to 24 hours post last dose of irrigation). 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 NCT05546762, 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 30 Jun 2026.

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