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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01589185
• Date of registration: 08/04/2012
• Prospective Registration: Yes
• Primary sponsor: Aridis Pharmaceuticals, Inc.
• Public title: Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)
• Scientific 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)
• Date of first enrolment: May 2012
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01589185
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium, France, Spain, United States

Contacts

• Name: Pierre-François M Laterre, MD
• Affiliation: Université catholique de Louvain, Brussels, Belgium

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pneumonia Due to Staphylococcus Aureus

Intervention(s)

Drug: KBSA301

Drug: Placebo

Primary Outcome(s)

Efficacy Endpoint: All-Cause Mortality by Day 28 [Time Frame: At Day 28 post infusion (Day 0)]

Secondary Outcome(s)

Efficacy: All-Cause Mortality (Day 21) [Time Frame: Patients who died during the specified timepoints (Day 21)]

Efficacy: All-Cause Mortality (Day 7) [Time Frame: Patients who died during the specified timepoints (Day 7)]

Efficacy: All-Cause Mortality (Day 14) [Time Frame: Patients who died during the specified timepoints (Day 14)]

Efficacy: All-Cause Mortality (End Of Study [EOS]) [Time Frame: Patients who died during the specified timepoints (by EOS), up to day 107]

Secondary ID(s)

KBSA301-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01589185