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Safety, Tolerability, Efficacy and Pharmacodynamics of CAL02 in Severe Pneumonia Caused by Streptococcus Pneumoniae

NCT02583373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-01-27

No results posted yet for this study

Summary

The objectives of this study are to assess the safety, tolerability, clinical and microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of standard of care antibiotic treatment.

Conditions

Interventions

DRUG

CAL02 Low-dose

Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion

DRUG

CAL02 High-dose

Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion

DRUG

Placebo

Placebo administered administered 2 times (24 hours apart) as i.v. infusion

Sponsors & Collaborators

  • Combioxin SA

    lead INDUSTRY

Principal Investigators

  • BRUNO FRANCOIS, MD · Centre Hospitalier Universitaire de Limoges CHU Dupuytren 2 Avenue Martin Luther King 87042 Limoges Cedex, France

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
2016-03-21
Primary Completion
2018-02-20
Completion
2018-02-20

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02583373 on ClinicalTrials.gov