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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-21

Study Completion Date

2018-02-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumonia Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CAL02 Low-dose

Liposomal formulation

Group Type ACTIVE_COMPARATOR

CAL02 Low-dose

Intervention Type DRUG

Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion

CAL02 High-dose

Liposomal formulation

Group Type ACTIVE_COMPARATOR

CAL02 High-dose

Intervention Type DRUG

Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion

Placebo

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered administered 2 times (24 hours apart) as i.v. infusion

Interventions

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CAL02 Low-dose

Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion

Intervention Type DRUG

CAL02 High-dose

Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion

Intervention Type DRUG

Placebo

Placebo administered administered 2 times (24 hours apart) as i.v. infusion

Intervention Type DRUG

Other Intervention Names

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CAL02 LD CAL02 HD Placebo CAL02

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No