CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
Aztreonam-Avibactam +1 moredrug
Likely dose
Aztreonam-Avibactam 167 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04486625
NCT04486625Phase 1Completed
CompareCT.gov

AN OPEN-LABEL, PARALLEL-GROUP, PHARMACOKINETIC STUDY OF MULTIPLE INTRAVENOUS DOSES OF AZTREONAM AND AVIBACTAM IN SUBJECTS WITH SEVERE RENAL IMPAIRMENT AND NORMAL RENAL FUNCTION

Pfizer·interventional·Posted Jul 24, 2020·Updated Jul 28, 2023

In Brief

A Phase 1 clinical trial evaluating Aztreonam-Avibactam for Renal Insufficiency. Completed, enrolled 11 participants across 1 site.

Detailed Summary

This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed dosing adjustment in severe renal impairment which was based on modelling/simulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJul 24, 2020
Enrollment StartAug 10, 2020
Primary CompletionSep 20, 2021
Study CompletionOct 18, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.9 years ago

Interventions

Aztreonam-Avibactamdrug

500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours

Aztreonam-Avibactamdrug

675/225 mg ATM/AVI loading infusion, followed by 675/225 mg ATM/AVI extended loading infusion, then 675/225 mg ATM/AVI maintenance dose infusion every 8 hours