CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6,496 enrolled
Drug / intervention
Standard of Careother
Likely dose
Not stated in 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/NCT03646227
NCT03646227N/ACompleted

Multi-Drug Resistant Organism Network - MDRO Network

Duke University·observational·Posted Aug 24, 2018·Updated Mar 6, 2023

In Brief

An observational study evaluating Standard of Care for Infections Resistant to Multiple Drugs and Bacterial Infections. Completed, enrolled 6,496 participants across 4 sites in 4 countries.

Detailed Summary

This study is specifically designed to provide observational data which can be used to help in the design of future randomized clinical trials on both therapeutics and diagnostics for MDRO infections. To this end, clinical and epidemiological data will be collected on patients who have MDRO isolated from clinical cultures during hospitalization, as well as descriptions of the outcomes of patients treated with various antimicrobial regimens. Molecular and microbiological characterization will also be performed on MDRO isolates. These data will include a detailed clinical and epidemiological description of patients including identifying potential barriers to enrollment in future trials. In addition, data will be collected on species, strain type, and mechanism of drug resistance of the causative organism. Knowing the molecular characteristics will further inform future trial design as not all diagnostics detect and not all therapeutics are active against the same mechanisms of resistance.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, China, Colombia, United States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 24, 2018
Enrollment StartJun 16, 2016
Primary CompletionMay 30, 2020
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.9 years ago

Interventions

Standard of Careother

There is no prescribed intervention for this study. Standard of care will be captured in the eCRF.