Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319235
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-13
Brief Title:
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG
Sponsor:
MB PHARMA sro
Organization:
MB PHARMA sro
Study Overview
Official Title:
A Prospective Randomized Double-blind Placebo-controlled Phase IIIa Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG in Bacterial Infection Treatment in Patients With Surgical Wounds
Status:
RECRUITING
Status Verified Date:
2024-03
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:
DUOFAG is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa It is an investigational medicinal product for the treatment of surgical site infections caused by S aureus and P aeruginosa
The primary objective of the study is to demonstrate the safety of DUOFAG and the clinical and microbiological change within 10 weeks after the start of treatment or until healing
The primary objective of the study is to demonstrate the safety of DUOFAG and the clinical and microbiological change within 10 weeks after the start of treatment or until healing
Detailed Description:
The study population will be recruited in two cohorts The microbiological population of the wound will be evaluated to analyze the effect of the treatment If the safety profile and treatment effect are going to be satisfactory the recruitment will proceed with Cohort 2
In both cohorts the Investigational Medicinal Product IMP or placebo the randomization ratio will be 11 will be applied twice a day for two weeks or until the commencement of healing
Patients will receive the standard of care during the whole study duration No concomitant treatment is planned during the treatment period
The Adverse Events will be recorded on basis of an open interview without soliciting questions and clinical observation In case of occurrence of an adverse event AE with moderate or severe intensity possibly related to IMP the treatment will be stopped and the AE will be followed up until resolution
Adverse Event descriptions their severity mild moderate or severe duration and their perceived relationship to the study medication probable possible unlikely not related and not sure will be recorded
The mLUMT modified Leg Ulcer Measurement Tool total score and individual item scores change since the baseline visit will be recorded
Time from the start of the study treatment until the bacterial infection eradication - i e the swab sample is negative on S aureus andor P aeruginosa will be recorded
Time from the start of the study treatment until the wound is closedhealed as assessed by investigator will be recorded
In both cohorts the Investigational Medicinal Product IMP or placebo the randomization ratio will be 11 will be applied twice a day for two weeks or until the commencement of healing
Patients will receive the standard of care during the whole study duration No concomitant treatment is planned during the treatment period
The Adverse Events will be recorded on basis of an open interview without soliciting questions and clinical observation In case of occurrence of an adverse event AE with moderate or severe intensity possibly related to IMP the treatment will be stopped and the AE will be followed up until resolution
Adverse Event descriptions their severity mild moderate or severe duration and their perceived relationship to the study medication probable possible unlikely not related and not sure will be recorded
The mLUMT modified Leg Ulcer Measurement Tool total score and individual item scores change since the baseline visit will be recorded
Time from the start of the study treatment until the bacterial infection eradication - i e the swab sample is negative on S aureus andor P aeruginosa will be recorded
Time from the start of the study treatment until the wound is closedhealed as assessed by investigator will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002412-23 | EUDRACT_NUMBER | None | None |