Ignite Creation Date:
2024-05-06 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03489629
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2018-03-29
Brief Title:
STaph Aureus Resistance-Treat Early and Repeat STAR-TER
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
STaph Aureus Resistance-Treat Early and Repeat STAR-TER
Status:
RECRUITING
Status Verified Date:
2024-04
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:
STAR-TER
Brief Summary:
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus MRSA in patients with cystic fibrosis
Detailed Description:
This is an open-label multi-center interventional trial in Cystic Fibrosis CF patients with new MRSA isolated from the respiratory tract oropharyngeal OP OP swab sputum or bronchoscopy at a clinical encounter
Forty-two subjects with new MRSA infection will be enrolled and will receive two weeks of oral trimethoprim-sulfamethoxazole TMP-SMX or minocycline depending on age allergies and antibiotic resistance of prior isolate for 14 days and nasal mupirocin for 5 days Subjects old enough to do so will use oral disinfectant gurgle 012 chlorhexidine gluconate oral rinse for 14 days The primary endpoint will be the proportion of positive MRSA respiratory cultures at Day 28 and this will be compared to our prior STAR-Too results
Subjects will then have a 14 day wash-out period ie no TMP-SMX or minocycline from Day 14 to Day 28 and all participants will repeat the treatment protocol from Day 29 to Day 42 Repeat cultures will be done at day 56 7 days most likely combined with their next clinic visit Results of Day 56 cultures will be an exploratory secondary outcome
A subsequent visit will be 3 months later with their routine clinic appointment Any interim clinic visits will be used to obtain repeat cultures and clinical data
Assessment of MRSA culture status will be by OP swab for all subjects with additional sputum in those who expectorate
Total duration of an individual subjects participation will be six months Total duration of the study is expected to be 42 months which includes data analyses and publication
Due to COVID 19 restrictions a study amendment was filed in March 2020 for subjects currently active subjects that allowed remote study visit for V3 and V4 Cultures were collected at home and mailed to the Core Study lab clinical case forms and surveys were completed via video visits These changes were approved by each study site that this was relevant to ie 4 study sites had subjects active at that time
Forty-two subjects with new MRSA infection will be enrolled and will receive two weeks of oral trimethoprim-sulfamethoxazole TMP-SMX or minocycline depending on age allergies and antibiotic resistance of prior isolate for 14 days and nasal mupirocin for 5 days Subjects old enough to do so will use oral disinfectant gurgle 012 chlorhexidine gluconate oral rinse for 14 days The primary endpoint will be the proportion of positive MRSA respiratory cultures at Day 28 and this will be compared to our prior STAR-Too results
Subjects will then have a 14 day wash-out period ie no TMP-SMX or minocycline from Day 14 to Day 28 and all participants will repeat the treatment protocol from Day 29 to Day 42 Repeat cultures will be done at day 56 7 days most likely combined with their next clinic visit Results of Day 56 cultures will be an exploratory secondary outcome
A subsequent visit will be 3 months later with their routine clinic appointment Any interim clinic visits will be used to obtain repeat cultures and clinical data
Assessment of MRSA culture status will be by OP swab for all subjects with additional sputum in those who expectorate
Total duration of an individual subjects participation will be six months Total duration of the study is expected to be 42 months which includes data analyses and publication
Due to COVID 19 restrictions a study amendment was filed in March 2020 for subjects currently active subjects that allowed remote study visit for V3 and V4 Cultures were collected at home and mailed to the Core Study lab clinical case forms and surveys were completed via video visits These changes were approved by each study site that this was relevant to ie 4 study sites had subjects active at that time
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?:
True
Is an FDA AA801 Violation?:
None