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NCT04147221 · ClinicalTrials.gov registry record · Phase 1
Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance
A Phase 1 study of Sepsis, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT04147221 is a Phase 1 study of Sepsis that has completed, run by Hartford Hospital. The registered enrollment target is 9 participants, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04147221, a Phase 1 study of Sepsis, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
Critically ill patients with sepsis undergo several physiological alterations that can alter the distribution, metabolism, and elimination of drugs. Some patients with sepsis may realize enhanced cardiac output leading to increases in glomerular filtration that result in increasing drug clearance. This clinical state is referred as Augmented Renal Clearance (ARC). Importantly, many beta-lactam antibiotics can be adversely affected by ARC, and some of these agents required increasing dosage to compensate for enhanced clearance. Imipenem-relebactam is a new broad spectrum antibiotic. This study is designed to assess the pharmacokinetics of both components, imipenem and relebactam, in critically ill patients with ARC.
Conditions Studied
Interventions
- DRUG Imipenem-relebactam
Study Locations (1)
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-02-10 |
| Est. Completion | 2021-09-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04147221
The ClinicalTrials.gov registry entry for NCT04147221 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower). The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which Imipenem-relebactam is the first listed.
NCT04147221 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT04147221 about?
NCT04147221 is a clinical study titled "Imipenem-Relebactam Pharmacokinetics in Augmented Renal Clearance". Critically ill patients with sepsis undergo several physiological alterations that can alter the distribution, metabolism, and elimination of drugs. Some patients with sepsis may realize enhanced cardiac output leading to increases in glomerular filtration that result in increasing drug clearance. T...
What is the current status of trial NCT04147221?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2020-02-10. Estimated completion is 2021-09-19.
What conditions does trial NCT04147221 study?
This clinical trial studies the following conditions: Sepsis.
What interventions are being tested in trial NCT04147221?
The interventions under investigation include: Imipenem-relebactam (DRUG).
Who is sponsoring clinical trial NCT04147221?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04147221 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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