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Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01589185
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : April 8, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Aridis Pharmaceuticals, Inc.

Brief Summary:
The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.

Condition or disease Intervention/treatment Phase
Pneumonia Due to Staphylococcus Aureus Drug: KBSA301 Drug: Placebo Phase 1 Phase 2

Detailed Description:

S. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract infections worldwide. The frequencies of both nosocomial and community-acquired S. aureus infections have increased steadily over the years and the treatment of these infections has become more challenging due to the emergence of multi-drug resistant strains (e.g. methicillin-resistant Staphylococcus aureus).

S. aureus has several virulence factors that contribute to the pathogenesis of the infection. Amongst them, alpha-toxin that is involved in the pathogenesis of pneumonia, as it leads to apoptosis and cell lysis, in particular lymphocytes, macrophages, alveolar epithelial cells, pulmonary endothelium, and thrombocytes.

In spite of preventive measures for S. aureus infections and current medical treatment (mostly antibiotic therapy, alone or in combination), there is a clear unmet medical need in the clinic for additional treatment options. Passive immunotherapy with monoclonal antibodies may improve treatment options for severe and life-threatening infections like those caused by S. aureus.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of KBSA301 in Severe Pneumonia (S. Aureus)
Study Start Date : May 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: KBSA301, a monoclonal antibody dose 1
1 mg/kg KBSA301
Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301

Experimental: KBSA301, a monoclonal antibody dose 2
3 mg/kg KBSA301
Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301

Experimental: KBSA301, a monoclonal antibody dose 3
10 mg/kg KBSA301
Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301

Experimental: KBSA301, a monoclonal antibody dose 4
20 mg/kg KBSA301
Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301

Experimental: Placebo
KBSA301-placebo
Drug: Placebo
Placebo administered as a single intravenous infusion
Other Name: Placebo KBSA301




Primary Outcome Measures :
  1. Efficacy Endpoint: All-Cause Mortality by Day 28 [ Time Frame: At Day 28 post infusion (Day 0) ]
    A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.


Secondary Outcome Measures :
  1. Efficacy: All-Cause Mortality (End Of Study [EOS]) [ Time Frame: Patients who died during the specified timepoints (by EOS), up to day 107 ]
    A summary of the number (%) of patients who died on or before timepoints Day EOS (mITT population) is provided, by treatment group (overall) and placebo.

  2. Efficacy: All-Cause Mortality (Day 14) [ Time Frame: Patients who died during the specified timepoints (Day 14) ]
    A summary of the number (%) of patients who died on or before timepoints Day 14 visit (mITT population) is provided, by treatment group (overall) and placebo.

  3. Efficacy: All-Cause Mortality (Day 7) [ Time Frame: Patients who died during the specified timepoints (Day 7) ]
    A summary of the number (%) of patients who died on or before timepoints Day 7 visit (mITT population) is provided, by treatment group (overall) and placebo.

  4. Efficacy: All-Cause Mortality (Day 21) [ Time Frame: Patients who died during the specified timepoints (Day 21) ]
    A summary of the number (%) of patients who died on or before timepoints Day 21 visit (mITT population) is provided, by treatment group (overall) and placebo.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Adult male or female patients ≥ 18 years and ≤ 70 years of age
  • Severe pneumonia caused by S. aureus (either methicillin-resistant or methicillin-sensitive) managed in an ICU
  • APACHE II of ≤30 at the time of diagnosis
  • Identification of S. aureus
  • Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines

Exclusion Criteria:

  • Women of child bearing potential are excluded from the participation from the study unless they have a negative pregnancy test at baseline and during the course of the study. Postmenopausal women or females that have been surgically sterilized are allowed to participate.
  • Hypersensitivity to excipients or to any prescribed medication
  • Severe neutropenia, lymphoma or anticipated chemotherapy
  • Patients who have long-term tracheostomy
  • Current or recent investigational drug (within 30 days of enrollment, or 5 half-lives of the investigational compound, whichever is longer)
  • Presence of meningitis, endocarditis, or osteomyelitis
  • Acquired immune deficiency syndrome (AIDS) with cluster of differentiation 4 (CD4) count <200 cells/ml
  • Known bronchial obstruction or a history of post-obstructive pneumonia.
  • Active primary lung cancer or another malignancy metastatic to the lungs
  • Cystic fibrosis, known or suspected Pneumocystis jiroveci pneumonia, or known or suspected active tuberculosis
  • Immunosuppressive therapy
  • Liver function deficiency
  • Moribund clinical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589185


Locations
Show Show 18 study locations
Sponsors and Collaborators
Aridis Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Pierre-François M Laterre, MD Université catholique de Louvain, Brussels, Belgium
Publications of Results:
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Responsible Party: Aridis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01589185    
Other Study ID Numbers: KBSA301-001
First Posted: May 1, 2012    Key Record Dates
Results First Posted: April 8, 2020
Last Update Posted: April 24, 2020
Last Verified: March 2020
Keywords provided by Aridis Pharmaceuticals, Inc.:
Pneumonia
Monoclonal antibody
Staphylococcus aureus
Additional relevant MeSH terms:
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Pneumonia, Staphylococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial