Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03978091
The ClinicalTrials.gov registry entry for NCT03978091 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 8 other Bacterial Infection trials with a reported enrollment target (52% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Bacterial Infection
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.
-
Safety of Intravenous Apramycin in Adults
COMPLETED · Phase 1
-
Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)
RECRUITING · Phase 4
-
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
RECRUITING · Phase 4
-
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
COMPLETED · Phase 2
-
Larval Debridement Therapy Versus Sharp Debridement to Remove Biofilm
COMPLETED · NA
-
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.