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Severe SepsisPhase 2SCIENSNCT02246595

Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction

A Phase 2 study testing CaCP29 in people with Severe Sepsis and Septic Shock, run by InflaRx GmbH at 11 sites in Germany.

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

The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Sepsis, Septic Shock
What is being tested?
CaCP29
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
11 sitesGermany
Study dates
Apr 2014to Dec 2015
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

  • Male or female patients >= 18 years old
  • Written informed consent
  • Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS) not explained by other reasons. These criteria should be present within 12 hours prior to screening
  • Suspected or confirmed abdominal or pulmonary infection at screening
  • Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection
  • At least one of the following acute organ dysfunctions due to sepsis. Each organ dysfunction must have occurred within 12 hours prior to screening, cannot mainly be explained by other disease processes than sepsis and is judged by the investigator as being caused or directly related to an abdominal or pulmonary infectious focus:
Show all 14Show fewer
  • respiratory
  • renal
  • hematologic
  • metabolic
  • cardiovascular (occurred within the last three hours)
  • Reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process
  • At least one of the sepsis related organ dysfunction detected at screening is still present
  • Current treatment with broad spectrum i.v. antibiotics has been started or is ongoing

Who cannot join

  • Sepsis of other primary cause than pulmonary or abdominal source
  • Weight > 130 kg at screening
  • Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
  • Patients receiving the following concomitant medication within 14 days prior to screening:
  • Calcineurin inhibitors (e.g., ciclosporine, tacrolimus)
  • Proliferation inhibitors (e.g., everolimus, sirolimus)
Show all 22Show fewer
  • Anti-metabolites (e.g., mycophenolate, mycophenolic acid, azathioprine)
  • High dose corticosteroids (e.g., > 50mg prednisolon per day or equivalent)
  • Patients receiving high dose immunoglobulins within 3 months prior to screening
  • Patients with following abnormal laboratory result: Neutrocytopenia with neutrophil count < 1,000/mm3 unless likely due to sepsis
  • General criteria:
  • Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
  • Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
  • Participation in any interventional clinical trial within the last three months
  • Prior participation in this clinical trial
  • Patient is chronically bed-bound prior to the onset of sepsis
  • Known intravenous drug abuse
  • Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
  • No commitment to full aggressive life support (e.g., do not resuscitate order)
  • Time frame between detection of a non cardiovascular organ dysfunction and start of randomization procedure is more than 15 hours
  • Time frame between detection of a cardiovascular organ dysfunction and start of randomization is more than six hours
  • Organ dysfunctions are unlikely to be persistent for next three hours

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Study Site

    Aachen

  • Study Site

    Augsburg

  • Study Site

    Bad Saarow

  • Study Site

    Berlin

  • Study Site

    Göttingen

  • Study Site

    Greifswald

  • Study Site

    Hamburg

  • Study Site

    Jena

  • Study Site

    Kiel

  • Study Site

    Leipzig

  • Study Site

    Oldenburg

Other trials in Germany

About this study

Official title: A Phase II Randomized, Placebo-controlled, Double-blind, Dose Controlled Trial in Patients Suffering From Early, Newly Developing Abdominal or Pulmonary Derived Septic Organ Dysfunction to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and to Estimate Efficacy of the New Humanized Monoclonal i.v. Administered Antibody CaCP29

The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.

Being tested
CaCP29, Placebo
Keywords
Sepsis, Severe Sepsis, Septic Shock, Systemic Inflammatory Response Syndrome, Organ Dysfunction
Medical subject headings
Sepsis, Shock, Septic, Systemic Inflammatory Response Syndrome

What participants receive

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

  • CaCP29Biological

    Also called IFX-1

  • PlaceboBiological

Study groups in NCT02246595
Study groupRoleWhat they receive
CaCP29Active comparatordose escalating i.v. administration of CaCP29 (verum)
Receives: Biological: CaCP29
PlaceboPlacebo comparatordose escalation mimicing i.v. placebo treatment:
Receives: Biological: Placebo

What is being measured

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

  1. Plasma Concentration of CaCP29

    Pharmacokinetic measures include

    • Plasma concentration over time
    • Maximum observed concentration per infusion
    • Concentration measured immediately before next dosing
    • Area under the curve of plasma concentration per infusion
    • Mean concentration per infusion
    • Terminal phase half-life

    Measured: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28

  2. Assess the pharmacodynamic (PD) effects of CaCP29 on the change from baseline in plasma concentrations of C5a

    Measured: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28

  3. Safety variables will be summarized using descriptive statistics based on adverse event collection

    Measured: 28 days

Secondary outcomes (7)

  1. Anti-drug antibodies (ADA)

    The development of ADA will be described by:

    • Number of patients with detection of anti-drug antibody (ADA)
    • Number of patients with detection of ADA at each time point measured

    Measured: 28 days or hospital discharge

  2. All-cause mortality rate

    Measured: 28 days

  3. Morbidity

    • Mean SOFA until Day 10
    • Modified mean SOFA until day 10 (calculated by omitting the Central Nervous System sub-score and calculating the renal subscore without taking urine output into consideration)
    • Mean SOFA Sub-scores until Day 10
    • Days on ICU until Day 28
    • Number of patients ventilated until Day 14
    • Ventilator-free days until Day 14
    • Numbers of patients with renal replacement therapy (RRT) until Day 14
    • RRT-free days until Day 14
    • Numbers of patients with administration of vasopressor until Day 14
    • Vasopressor-free days until Day 14
    • Days without antimicrobial therapy (AMT) until Day 14

    Measured: daily

  4. Fluid balance

    • Mean daily total fluid intake until Day 28 (maximal until ICU discharge)
    • Mean daily total fluid output until Day 28 (maximal until ICU discharge)
    • Mean daily fluid balance until Day 28 (maximal until ICU discharge)

    Measured: 28 days or ICU discharge

  5. Change in routine laboratory parameters as compared to baseline

    Measured: Days 1, 2, 3, 4, 5, 8, 13, 28

  6. Change in ECG as compared to baseline

    Measured: Days 2, 4, 8, 28

  7. Change in vital signs as compared to baseline

    Measured: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Day 28

Timeline

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

  1. First posted23 Sep 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

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
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02246595
Sponsor's protocol ID
IFX-1-P2.1
Other IDs
2013-001037-40
Acronym
SCIENS
Status last verified
Apr 2016
First submitted
18 Sep 2014
Last updated
25 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CaCP29 in people with Severe Sepsis and Septic Shock, run by InflaRx GmbH at 11 sites in Germany.

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 14 inclusion and 22 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 25 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 11 sites in Germany. 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 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?

Plasma Concentration of CaCP29 (time frame: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28). The study lists 3 primary outcomes in all. 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 NCT02246595.

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 25 Apr 2016.

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