NCT01589185

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2012

Longer than P75 for phase_1

Geographic Reach
4 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

April 8, 2020

Completed
Last Updated

April 24, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

April 8, 2012

Results QC Date

July 9, 2019

Last Update Submit

April 9, 2020

Conditions

Pneumonia Due to Staphylococcus Aureus

Keywords

PneumoniaMonoclonal antibodyStaphylococcus aureus

Outcome Measures

Primary Outcomes (1)

  • Efficacy Endpoint: All-Cause Mortality by Day 28

    A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.

    At Day 28 post infusion (Day 0)

Secondary Outcomes (4)

  • Efficacy: All-Cause Mortality (End Of Study [EOS])

    Patients who died during the specified timepoints (by EOS), up to day 107

  • Efficacy: All-Cause Mortality (Day 14)

    Patients who died during the specified timepoints (Day 14)

  • Efficacy: All-Cause Mortality (Day 7)

    Patients who died during the specified timepoints (Day 7)

  • Efficacy: All-Cause Mortality (Day 21)

    Patients who died during the specified timepoints (Day 21)

Study Arms (5)

KBSA301, a monoclonal antibody dose 1

EXPERIMENTAL

1 mg/kg KBSA301

Drug: KBSA301

KBSA301, a monoclonal antibody dose 2

EXPERIMENTAL

3 mg/kg KBSA301

Drug: KBSA301

KBSA301, a monoclonal antibody dose 3

EXPERIMENTAL

10 mg/kg KBSA301

Drug: KBSA301

KBSA301, a monoclonal antibody dose 4

EXPERIMENTAL

20 mg/kg KBSA301

Drug: KBSA301

Placebo

EXPERIMENTAL

KBSA301-placebo

Drug: Placebo

Interventions

KBSA301DRUG

KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.

Also known as: AR301
KBSA301, a monoclonal antibody dose 1KBSA301, a monoclonal antibody dose 2KBSA301, a monoclonal antibody dose 3KBSA301, a monoclonal antibody dose 4
PlaceboDRUG

Placebo administered as a single intravenous infusion

Also known as: Placebo KBSA301
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Site 83

Jacksonville, Florida, 32209, United States

Location

Site 81

Oklahoma City, Oklahoma, 73104, United States

Location

Site 80

Houston, Texas, 77030, United States

Location

Site 11

Brussels, Belgium

Location

Site 16

Liège, Belgium

Location

Site 41

Angers, France

Location

Site 40

Angoulême, France

Location

Site 32

Argenteuil, France

Location

Site 34

Colombes, France

Location

Site 36

Dijon, France

Location

Site 35

La Roche-sur-Yon, France

Location

Site 31

Limoges, France

Location

Site 39

Lyon, France

Location

Site 37

Nantes, France

Location

Site 38

Orléans, France

Location

Site 33

Tours, France

Location

Site 51

Barcelona, Spain

Location

Site 52

Barcelona, Spain

Location

Related Publications (1)

  • Francois B, Mercier E, Gonzalez C, Asehnoune K, Nseir S, Fiancette M, Desachy A, Plantefeve G, Meziani F, de Lame PA, Laterre PF; MASTER 1 study group. Safety and tolerability of a single administration of AR-301, a human monoclonal antibody, in ICU patients with severe pneumonia caused by Staphylococcus aureus: first-in-human trial. Intensive Care Med. 2018 Nov;44(11):1787-1796. doi: 10.1007/s00134-018-5229-2. Epub 2018 Oct 21.

    PMID: 30343314RESULT

MeSH Terms

Conditions

PneumoniaStaphylococcal Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Limitations and Caveats

The study was not designed and not powered to demonstrate statistically significant differences between treatment groups. All efficacy results are descriptive and exploratory.

Results Point of Contact

Title
Lynne Deans, M.T.
Organization
Aridis Pharmaceuticals, Inc.
deansl@aridispharma.com
408-385-1742

Study Officials

  • Pierre-François M Laterre, MD

    Université catholique de Louvain, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2012

First Posted

May 1, 2012

Study Start

May 1, 2012

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

April 24, 2020

Results First Posted

April 8, 2020

Record last verified: 2020-03

Locations

US(3)BE(2)ES(2)FR(11)