Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06128213
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-07
Brief Title:
NRX-101 for Complicated Urinary Tract Infection UTI Including Pyelonephritis
Sponsor:
NeuroRx Inc
Organization:
NeuroRx Inc
Study Overview
Official Title:
An Open Label Study of NRX-101 for Patients With Acute Complicated Urinary Tract Infection Including Pyelonephritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study is to test NRX101 in participants with complicated urinary tract infections including pyelonephritis The main questions it aims to answer are
Does NRX101 help participants resolve UTIs
Is NRX101 safe for participants with UTIs
Participants will be seen in a doctors office approximately 6 times to
Answer a short 10 item questionnaire
Review of side effects
Urine tests
Blood draw about 10 ml or 2 teaspoons
Review of medications
Review any signs or symptoms of UTI
Vital signs and weight including blood pressure heart rate respiratory rate and temperature
Review of medical history
This is an open-label study of NRX101 which means both you and your doctor know what drug you are taking After the study is completed researchers will look at the data to see if NRX101 helps participants with complicated UTIs
Does NRX101 help participants resolve UTIs
Is NRX101 safe for participants with UTIs
Participants will be seen in a doctors office approximately 6 times to
Answer a short 10 item questionnaire
Review of side effects
Urine tests
Blood draw about 10 ml or 2 teaspoons
Review of medications
Review any signs or symptoms of UTI
Vital signs and weight including blood pressure heart rate respiratory rate and temperature
Review of medical history
This is an open-label study of NRX101 which means both you and your doctor know what drug you are taking After the study is completed researchers will look at the data to see if NRX101 helps participants with complicated UTIs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None