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Antibiotic
RO7223280 for Bacterial Infections
Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 1-3: from day 1 up to day 4; cohort 4: from day 1 up to day 5
Awards & highlights
Study Summary
This trial will study how a drug behaves in critically ill people with bacterial infections to ensure it's safe and effective.
Who is the study for?
This trial is for critically ill patients with bacterial infections who are in the ICU. It's for those diagnosed with hospital-acquired or ventilator-associated pneumonia, or bacteremia with a known infection focus. Excluded are individuals with catheter-related bacteraemia only, recent major surgery, or chronic severe liver problems.Check my eligibility
What is being tested?
The study tests how a single dose of RO7223280 (either 400 mg or 600 mg), given through an IV, behaves in the body and its safety profile in critically ill patients suffering from bacterial infections.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones related to antibiotics include allergic reactions, gastrointestinal issues like nausea and diarrhea, potential organ inflammation, and changes in blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohort 1-3: from day 1 up to day 4; cohort 4: from day 1 up to day 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 1-3: from day 1 up to day 4; cohort 4: from day 1 up to day 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma Concentrations of RO7223280
Secondary outcome measures
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 Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
Participants with mechanical ventilation who have a bronchoalveolar lavage (BAL) planned as a part of routine practice will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Group II: Cohort 3Experimental Treatment1 Intervention
Participants with mechanical ventilation at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Group III: Cohort 2Experimental Treatment1 Intervention
Participants with hospital-acquired bacterial pneumonia (HABP) and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Group IV: Cohort 1Experimental Treatment1 Intervention
Bacteremia participants without pneumonia and who are not mechanically ventilated at screening will be enrolled in this cohort. Participants will receive RO7223280 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7223280
2020
Completed Phase 1
~180
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,374 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,200 Previous Clinical Trials
888,474 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a medical condition that fits at least one of the following criteria:
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 2
- Group 3: Cohort 1
- Group 4: Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this clinical trial currently?
"Affirmative. The clinical trial is seeking a total of 27 participants, which can be found through the information posted on clinicaltrials.gov that was last modified November 10th 2022 from its initial posting date of November 30th 2022 at 3 different locations."
Answered by AI
Has Cohort C received the regulatory approval of the FDA?
"As Cohort C is in the earliest stages of clinical trials, our team at Power has rated its safety as a 1. This reflects limited data on both efficacy and safety available for this drug."
Answered by AI
How many participants can take part in this clinical investigation?
"The sponsor, Hoffmann-La Roche, requires 27 eligible participants to execute the trial at two seperate locations: University of Louisville Physicians in Louisville, Kentucky and East Carolina University (ECU) Physicians - Infectious disease Clinic - Greenville in Greenville, North carolina."
Answered by AI
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