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Safety, Tolerability, Efficacy and Pharmacodynamics of CAL02 in Severe Pneumonia Caused by Streptococcus Pneumoniae

This study is currently recruiting participants.
Verified July 2017 by Combioxin SA
Sponsor:
ClinicalTrials.gov Identifier:
NCT02583373
First Posted: October 22, 2015
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Combioxin SA
October 19, 2015
October 22, 2015
July 24, 2017
March 2016
January 2018   (Final data collection date for primary outcome measure)
Frequency, severity and characteristics of adverse events after two iv. administrations of CAL02. [ Time Frame: 29 days ]
To determine the safety profile of CAL02
Frequency, severity and characteristics of adverse events after two iv. administrations of CAL02. [ Time Frame: 29 days ]
Complete list of historical versions of study NCT02583373 on ClinicalTrials.gov Archive Site
  • Clinical efficacy: cure. [ Time Frame: 29 days. ]
    Complete resolution of signs and symptoms of pneumonia
  • Pharmacodynamic effects. [ Time Frame: 29 days. ]
    Measuring biomarkers (CRP/PCT).
  • Microbiological efficacy. [ Time Frame: 29 days. ]
    Eradication: baseline isolate not present in repeat culture from original infection site
  • Survival. [ Time Frame: 29 days ]
    Assessment of 28 days all cause mortality.
  • Clinical efficacy: cure. [ Time Frame: 29 days. ]
    Assessment of clinical outcome.
  • Pharmacodynamic effects. [ Time Frame: 29 days. ]
    Measuring biomarkers (CRP/PCT).
  • Microbiological efficacy. [ Time Frame: 29 days. ]
    Assessment of pathogen eradication.
  • Survival. [ Time Frame: 29 days ]
    Assessment of 28 days all cause mortality.
Not Provided
Not Provided
 
Safety, Tolerability, Efficacy and Pharmacodynamics of CAL02 in Severe Pneumonia Caused by Streptococcus Pneumoniae
Randomised, Multicentre, Double-blind, Placebo-controlled Study to Assess the Safety, Efficacy and Pharmacodynamics After the Intravenous Administration of CAL02 in Severe Community-acquired Pneumonia Due to Streptococcus Pneumoniae
The objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of standard of care antibiotic treatment.
Streptococcus pneumoniae is the most frequently identified pathogen of community-acquired bacterial pneumonia and its severe forms are associated with high morbidity and mortality, despite pneumococcal vaccines and medical treatment (antibiotic therapy, alone or in combination). Bacterial toxins, such as the pore-forming toxin (PFT) pneumolysin (from Streptococcus pneumoniae), are involved in the development of invasive disease and play a key role in severe and fatal complications. CAL02 offers a novel therapeutic approach by neutralising bacterial toxins, such as pneumolysin, which recognise specific microdomains on host cell membranes, called lipid rafts.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pneumonia
  • Pneumococcal Infections
  • Drug: CAL02 Low-dose
    Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion
    Other Name: CAL02 LD
  • Drug: CAL02 High-dose
    Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion
    Other Name: CAL02 HD
  • Drug: Placebo
    Placebo administered administered 2 times (24 hours apart) as i.v. infusion
    Other Name: Placebo CAL02
  • Active Comparator: CAL02 Low-dose
    Liposomal formulation
    Intervention: Drug: CAL02 Low-dose
  • Active Comparator: CAL02 High-dose
    Liposomal formulation
    Intervention: Drug: CAL02 High-dose
  • Placebo Comparator: Placebo
    Saline
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
June 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult male or female patients ≥ 18 years and ≤ 80 years of age
  • Body weight 40-140 kg
  • Severe pneumonia caused by Streptococcus pneumoniae managed in an ICU
  • CURB-65 score ≥ 3 in patients aged > 65 and CURB-65 ≥ 2 in patients aged < 65
  • Streptococcus pneumoniae identification with the urine antigen test or any other proven documented identification method
  • Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines

Exclusion Criteria:

  • Patients with hospital-acquired-, health care-acquired- or ventilator- associated-pneumonia
  • More than (i) 12 hours since diagnosis of severe CAPP and (ii) 24 hours or 60 hours since antibiotic treatment IV or per os, respectively, unless documented not to be active against S. pneumoniae, will have elapsed at the time of IMP administration
  • APACHE II score > 30 points
  • SOFA score > 12 points
  • Inability to maintain a mean arterial pressure ≥ 50 mm Hg
  • Known hypersensitivity to liposomal formulations
  • Patients with severe neutropenia or lymphoma or current or anticipated chemotherapy
  • End-stage neuromuscular disorders
  • Patients who have long-term tracheostomy
  • Current or recent participation in an investigational study
  • Presence of other pneumococcal site infection
  • Patients with known acquired immune deficiency syndrome (AIDS) with CD4 count < 200 cells/mL
  • Patients with known post-obstructive pneumonia (active primary lung cancer or another malignancy metastatic to the lungs)
  • Patients with cystic fibrosis, Pneumocystis jiroveci pneumonia, or active tuberculosis
  • Patients receiving immunosuppressant therapy
  • Patients with a known liver function deficiency
  • Splenectomised patients
  • Patients who have experienced an allergic reaction to eggs
  • Moribund clinical condition
  • Nursing and pregnant women
  • Women of child bearing potential not using an effective contraception.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: ANTONIO PEREZ, MD +41228108372 toni.perez@combioxin.com
Contact: SAMAREH AZEREDO DA SILVEIRA LAJAUNIAS, PhD +41228108372 samareh.lajaunias@combioxin.com
Belgium,   France
 
 
NCT02583373
CAL02-001
Yes
Not Provided
Not Provided
Combioxin SA
Combioxin SA
Not Provided
Principal Investigator: BRUNO FRANCOIS, MD Centre Hospitalier Universitaire de Limoges CHU Dupuytren 2 Avenue Martin Luther King 87042 Limoges Cedex, France
Combioxin SA
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP