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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: Completed Phase 1 study of Sepsis, sponsored by Hartford Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The clearance in liters/hour of imipenem from the plasma of critically ill patients with augmented renal clearance
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 |
What the finished NCT04147221 record still lists
NCT04147221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 6,565-participant average among 90 other Sepsis trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Sepsis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04147221's enrollment target sits among peer trials
9 87th of 90 higher than 4 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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