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

NCT01589185 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-04-24

Study results available
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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.

Conditions

  • Pneumonia Due to Staphylococcus Aureus

Interventions

DRUG

KBSA301

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

DRUG

Placebo

Placebo administered as a single intravenous infusion

Sponsors & Collaborators

  • Aridis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Pierre-François M Laterre, MD · Université catholique de Louvain, Brussels, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-05-31
Completion
2016-09-30

Countries

  • United States
  • Belgium
  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589185 on ClinicalTrials.gov