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PneumoniaPhase 2NCT01532544

Integrilin and Ilomedin in Combination in Comparison to Standard Treatment in Severe Pneumonia Patients With Severe Sepsis

A Phase 2 study testing Ilomedin and Integrilin and low molecular weight heparin. in people with Pneumonia, run by Thrombologic ApS at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an investigator sponsored double-blinded, multinational, multi center, randomized (2:1 active:placebo), placebo-controlled, phase IIa trial in severe pneumonia patients with severe sepsis or septic shock, investigating the safety and efficacy of co-administration of Iloprost and escalating doses of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumonia
What is being tested?
Ilomedin and Integrilin and low molecular weight heparin.
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
4 sitesin 2 countries
Study dates
Jun 2012to Mar 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age AND
  • Suspected or proven bacterial pneumonia requiring administration of antibiotics:
  • Clinical diagnosis of pneumonia, (i.e. new or increased cough, production of purulent sputum or a change in the character of sputum in subjects who normally have purulent sputum, typical auscultatory findings of pneumonia on chest examination) and:
  • chest radiograph or CT within the last 24 hr showing a pulmonary infiltrate.
  • Dyspnea and/or tachypnea (>20 breaths/minute) or mechanical ventilation
  • Two or more systemic inflammatory response syndrome (SIRS) criteria within the last 24 hours:
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  • Temperature </= 36˚ C or >/= 38˚C
  • Heart rate >/= 90 beats per minute
  • Mechanical ventilation for acute respiratory process or respiratory rate >/= 20 breaths per minute or PaC02 < 4.2 kPa
  • WBC >/= 12,000/mm³ OR </= 4,000/mm³ OR > 10% bands
  • At least one organ failure beyond respiratory failure (cerebral, cardiovascular, hepatic, renal or coagulation within the last 24 hours (> 2 in SOFA score for the specific organ system) AND
  • Can be randomized into trial and dosed < 48 h after severe sepsis diagnosis AND
  • Consent is obtainable -

Who cannot join

  • Patient is pregnant or breast-feeding
  • Patient weigh more than 125 kg
  • Patients with known allergy towards any of the investigational products or contraindications which should be excluded according to the investigational product specifications
  • Investigators clinical decision deeming study participation not favourable for the patient
  • Patients in whom the clinician finds antithrombotic therapy contraindicated - prophylaxis included
  • Patients at increased risk of bleeding: Surgery in the previous 12 h, expected surgery within 72 h, epidural or spinal puncture in the previous 12 h, platelet count less than 30,000/mm3 in the previous 24 h, INR above 2.0 in the previous 24 h, need of blood products for bleeding in the previous 24 h, treatment with any antithrombotics within 12 h (profylaxis excepted), current or previous intracranial bleeding or traumatic brain or spinal injury within the last month.
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  • Patients requiring any form of antithrombotics (beyond profylaxis) in therapeutic doses or prothrombotics in any dose, including,
  • unfractionated heparin within 8 hours before the infusion (prophylactic heparin up to 15,000 U/day permitted).
  • Low-molecular-weight heparin within 12 hours (prophylactic doses permitted).
  • exceeded the upper limit of normal.
  • Acetylsalicylic acid more than 650 mg/day within 3 days before the study.
  • Thrombolytic therapy within 3 days before the study (catheter clearance doses permitted).
  • Glycoprotein IIb-IIIa antagonists within 7 days before the study.
  • Antithrombin III with dose greater than 10,000 U within 12 hours before the study.
  • Protein C within 24 hours of the study.
  • Previous diagnosed condition that might mimic or complicate the course and evaluation of the infectious disease process (severe bronchiectasis, lung abcess or empyema, aspiration pneumonia, active tuberculosis, pulmonary malignancy, cystic fibrosis, severe chronic interstitial pneumonia, COPD or other forms of chronic lung disease requiring home oxygen treatment or resulting in chronic CO2 retention, , etc.)
  • Patient not expected to survive more than 30 days because of uncorrectable medical or surgical condition other than sepsis
  • Patient with acute or chronic renal failure requiring dialysis (renal failure without need for dialysis permitted).
  • Patient with hematological malignancies of any kind
  • Patients who have undergone transplantation of bone marrow, liver, pancreas, heart, lung, or bowel (kidney transplant permitted)
  • Patient has known hypercoagulable condition:
  • APC resistance Hereditary protein C, protein S, or antithrombin III deficiency Anticardiolipin or antiphospholipid antibody Lupus anticoagulant Homocysteinemia Recent or highly suspected pulmonary embolism or deep venous thrombosis (within 3 months)
  • Patients with known congenital hypocoagulable diseases
  • Patient with known AIDS
  • Patient with known primary pulmonary hypertension

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Denmark2 sites

  • University hospital Copenhagen

    Copenhagen, 2100

  • Vejle hospital

    Vejle

Other trials in Denmark

Finland2 sites

  • Kuopio University Hospital

    Kuopio

  • Tampere University Hospital

    Tampere, 33521

Other trials in Finland

About this study

Official title: Double-blinded, Randomized Trial in Severe Pneumonia Patients With Severe Sepsis Investigating the Safety and Efficacy of Co-administration of Iloprost and Ascending Doses of Eptifibatide Compared to Low-molecular-weight Heparin

This is an investigator sponsored double-blinded, multinational, multi center, randomized (2:1 active:placebo), placebo-controlled, phase IIa trial in severe pneumonia patients with severe sepsis or septic shock, investigating the safety and efficacy of co-administration of Iloprost and escalating doses of Eptifibatide for continuous intravenous infusion in totally 36 patients.

Conditions
Pneumonia
Being tested
Ilomedin and Integrilin, low molecular weight heparin.
Keywords
Severe pneumonia
Medical subject headings
Pneumonia

What participants receive

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

  • Ilomedin and IntegrilinDrug

    Also called Integrilin and Ilomedin

    Continuous infusion

  • low molecular weight heparin.Drug

Study groups in NCT01532544
Study groupRoleWhat they receive
Integrilin and Ilomedin given as continous infusionExperimentalNot described
Receives: Drug: Ilomedin and Integrilin
Standard treatment daily doses of low molecular weight heparinPlacebo comparatorStandard treatment daily doses of low molecular weight heparin.
Receives: Drug: low molecular weight heparin.

What is being measured

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

  1. Change in platelet count from baseline to 72 hours post treatment

    Will be from pre-study drug administration until 7 days

    Measured: 11 bloodsamples over 7 days

Secondary outcomes (2)

  1. Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more) (KyperSept trial)

    If longer in the ICU ward followed until discharged.

    Measured: 7 days

  2. Days of vasopressor, ventilator and renal replacement therapy and use of blood product (in ICU) after randomization

    Followed longer if not discharged from the ICU at day 7

    Measured: 7 days

Timeline

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

  1. First posted14 Feb 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: Difficulty recruiting patients, company closed down

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01532544
Sponsor's protocol ID
THR-PS-03
Other IDs
2011-002254-31
Status last verified
Apr 2016
First submitted
30 Jan 2012
Last updated
22 Apr 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ilomedin and Integrilin and low molecular weight heparin. in people with Pneumonia, run by Thrombologic ApS at 4 sites in 2 countries.

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 13 inclusion and 25 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: stopped early, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark, Finland. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Difficulty recruiting patients, company closed down). Results are not available in the source record.

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?

Change in platelet count from baseline to 72 hours post treatment (time frame: 11 bloodsamples over 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 NCT01532544.

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 22 Apr 2016.

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