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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Combioxin SA
Sponsor:
Information provided by (Responsible Party):
Combioxin SA
ClinicalTrials.gov Identifier:
NCT02583373
First received: October 19, 2015
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Pneumonia Pneumococcal Infections Drug: CAL02 Low-dose Drug: CAL02 High-dose Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Combioxin SA:

Primary Outcome Measures:
  • Frequency, severity and characteristics of adverse events after two iv. administrations of CAL02. [ Time Frame: 29 days ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 24
Study Start Date: March 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CAL02 Low-dose
Liposomal formulation
Drug: CAL02 Low-dose
Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion
Other Name: CAL02 LD
Active Comparator: CAL02 High-dose
Liposomal formulation
Drug: CAL02 High-dose
Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion
Other Name: CAL02 HD
Placebo Comparator: Placebo
Saline
Drug: Placebo
Placebo administered administered 2 times (24 hours apart) as i.v. infusion
Other Name: Placebo CAL02

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Streptococcus pneumoniae identification with the urine antigen test and, if feasible, a Gram+ stain from respiratory sample.
  • Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines

Exclusion Criteria:

  • Antibiotic treatment for > 12 hours IV or for > 48 hours per os, unless not active against Streptococcus pneumoniae
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02583373

Contacts
Contact: ANTONIO PEREZ, MD +41228108372 toni.perez@combioxin.com
Contact: SAMAREH AZEREDO DA SILVEIRA LAJAUNIAS, PhD +41228108372 samareh.lajaunias@combioxin.com

Locations
Belgium
St Luc University Hospital Recruiting
Brussels, Belgium
Contact: Pierre-François LATERRE, Prof.         
University Hospital Brussels Recruiting
Brussels, Belgium
Contact: Herbert SPAPEN, MD         
Clinique St Pierre Recruiting
Ottignies, Belgium
Contact: Thierry DUGERNIER, MD         
France
CHU Jean Minjoz Recruiting
Besancon, France
Contact: Jean-Christophe NAVELLOU, MD         
CHD Les Oudairies Recruiting
La Roche-sur-Yon, France
Contact: Gwenhael COLIN, MD         
Hôpital Mignot Recruiting
Le Chesnay, France
Contact: Jean-Pierre Bedos, MD         
CHU Dupuytren Recruiting
Limoges, France
Contact: Bruno FRANCOIS, MD         
Centre Hospitalier Régional d'ORLEANS Recruiting
Orléans, France
Contact: Thierry BOULAIN, MD         
CH Yves Le Foll Recruiting
Saint-Brieuc, France
Contact: Anne COURTE, MD         
CHRU de Tours Recruiting
Tours, France
Contact: Pierre-François DEQUIN, Prof         
Sponsors and Collaborators
Combioxin SA
Investigators
Principal Investigator: BRUNO FRANCOIS, MD Centre Hospitalier Universitaire de Limoges CHU Dupuytren 2 Avenue Martin Luther King 87042 Limoges Cedex, France
  More Information

Responsible Party: Combioxin SA
ClinicalTrials.gov Identifier: NCT02583373     History of Changes
Other Study ID Numbers: CAL02-001
Study First Received: October 19, 2015
Last Updated: December 12, 2016

Keywords provided by Combioxin SA:
Pneumonia
Streptococcus pneumoniae
Pneumolysin

Additional relevant MeSH terms:
Pneumonia
Pneumococcal Infections
Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial

ClinicalTrials.gov processed this record on July 21, 2017