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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pneumonia Due to Staphylococcus Aureus

In brief

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.

Key facts

Study ID

NCT01589185

Run by

Aridis Pharmaceuticals, Inc.

People needed

48

Starts

2012-05-01

Expected to finish

2016-09-01

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Site 83 — Jacksonville, Florida, United States
• Site 81 — Oklahoma City, Oklahoma, United States
• Site 80 — Houston, Texas, United States
• Site 11 — Brussels, Belgium
• Site 16 — Liège, Belgium
• Site 41 — Angers, France
• Site 40 — Angoulême, France
• Site 32 — Argenteuil, France
• Site 34 — Colombes, France
• Site 36 — Dijon, France
• Site 35 — La Roche-sur-Yon, France
• Site 31 — Limoges, France
• Site 39 — Lyon, France
• Site 37 — Nantes, France
• Site 38 — Orléans, France
• Site 33 — Tours, France
• Site 51 — Barcelona, Spain
• Site 52 — Barcelona, Spain

Full record on ClinicalTrials.gov

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