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Cohort A for Bacterial Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Bacterial InfectionRO7223280 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 600 mg RO7223280 in critically ill participants with bacterial infections.

Eligible Conditions
  • Bacterial Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

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IMI/REL

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From Day 1 up to Day 4

Day 3
Plasma Concentrations of RO7223280
Day 4
Percentage of Participants Who Died Due to Any Cause
Percentage of Participants With Adverse Events (AEs)
Percentage of Participants With Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Omadacycline Oral Tablet
1
Vabomere
2
IMI/REL

Trial Design

3 Treatment Groups

Cohort A
1 of 3
Cohort C
1 of 3
Cohort B
1 of 3

Experimental Treatment

27 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort A · No Placebo Group · Phase 1

Cohort A
Drug
Experimental Group · 1 Intervention: RO7223280 · Intervention Types: Drug
Cohort C
Drug
Experimental Group · 1 Intervention: RO7223280 · Intervention Types: Drug
Cohort B
Drug
Experimental Group · 1 Intervention: RO7223280 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 up to day 4

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,361 Previous Clinical Trials
1,068,054 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,147 Previous Clinical Trials
876,108 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are admitted to hospital with an acute illness requiring treatment in an intensive care unit (ICU).
You have a positive blood culture for a bacterial pathogen.
References

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