The second multi-centre intra-pleural sepsis trial (MIST2), to assess whether DNase or Alteplase, improve pleural fluid drainage in pleural infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57454527

Enrollment

210

Registered

2004-10-11

Start date

2003-10-11

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural infection Infections and Infestations Pleural infection

Interventions

Patients will be randomly assigned in the ratio 1:1:1:1 to either of the following regimes: Alteplase 10 mg bd (twice a day) intrapleurally + DNase 5 mg bd intrapleurallly

or Alteplase placebo intrapleurally + DNase 5 mg bd intrapleurally

or Alteplase 10 mg bd intrapleurally + DNase placebo intrapleurally

or Alteplase placebo intrapleurally + DNase placebo intrapleurally.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.A clinical presentation compatible with pleural infection 2. Has pleural fluid requiring drainage which is either purulent, gram stain positive, culture positive or acidic with a pH<7.2 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Age <18 years 2. Has previously received intra-pleural fibrinolytics or DNase for this empyema 3. Has a known sensitivity to DNase or tissue plasminogen activator 4. Has had a coincidental stroke, a major haemorrhage or major trauma 5. Has had major surgery in the previous 5 days 6. Has had a previous pneumonectomy on the side of infection Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test before randomisation) Expected survival less than three months from a different pathology to this empyema (e.g. metastatic lung carcinoma) Inability to give informed consent

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be radiographic improvement in area of pleural collection (between the area of the pleural collection on the CXR at randomisation and the chest radiograph taken on day 6/7).	—

Secondary

Measure	Time frame
Secondary outcome measure(s): 1. Changes in blood CRP from baseline to day 6/7 2. Time from randomisation to remain apyrexial for 36 hrs 3. Total pleural fluid drainage 4. Survival and need for surgery at 3 and 12 months	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026