drugset / Trial / NCT02583373

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

NCT02583373 ↗

Phase 1 Completed 19 enrolled Combioxin SA
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator CAL02 Other / unclassified 4 mg/kg Intravenous
Comparator CAL02 Other / unclassified 16 mg/kg Intravenous