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NCT03978091 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam
A Phase 1 study of Bacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03978091: Completed Phase 1 study of Bacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03978091 is a Phase 1 study of Bacterial Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 99-participant average among 8 other Bacterial Infection trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03978091, a Phase 1 study of Bacterial Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone. The study will have 6 arms, arms 1-4 are the single drug administration treatment groups and will include AVYCAZ per label dosing, AVYCAZ as a continuous infusion (CI), ATM per label dosing, and ATM as a CI. Arms 5 and 6 are the two AVYCAZ and ATM combination drug administration treatment groups. The duration of subject participation will be up to 44 days, and the total length of the study will be 15 months. The primary objective of this study is to describe the safety of two dosing regimens of AVYCAZ combined with ATM relative to AVYCAZ alone, and ATM alone in healthy adult subjects.
Primary Outcome
Adverse events include local and systemic reactions. All Grade 2 (moderate) adverse events were reported, regardless of relationship to study product. Number of participants with an AE are summarized by MedDRA system organ class (SOC). Each participant is only counted once per SOC.
Conditions Studied
Interventions
- DRUG AZACTAM
- DRUG Ceftazidime-Avibactam
Study Locations (1)
North Carolina
- Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-07-09 |
| Est. Completion | 2020-11-23 |
| Phase | Phase 1 |
What the finished NCT03978091 record still lists
NCT03978091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 99-participant average among 8 other Bacterial Infection trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Bacterial Infection appearing as the primary indexed condition, and to 2 interventions - of which AZACTAM is the first listed.
NCT03978091 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03978091 about?
NCT03978091 is a clinical study titled "A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam". This is a Phase I, open-label, non-randomized, single center study in 48 healthy adult male and female subjects, aged 18 to 45 years. This study is aimed to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone. The s...
What is the current status of trial NCT03978091?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-07-09. Estimated completion is 2020-11-23.
What conditions does trial NCT03978091 study?
This clinical trial studies the following conditions: Bacterial Infection.
What interventions are being tested in trial NCT03978091?
The interventions under investigation include: AZACTAM (DRUG), Ceftazidime-Avibactam (DRUG).
Who is sponsoring clinical trial NCT03978091?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03978091 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03978091's enrollment target sits among peer trials
48 6th of 8 higher than 3 of 8 other Bacterial Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Infection 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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