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Trial registered on ANZCTR
Registration number
ACTRN12624000973516
Ethics application status
Approved
Date submitted
20/06/2024
Date registered
9/08/2024
Date last updated
22/09/2024
Date data sharing statement initially provided
9/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
RECCE®327 Topical Gel Study for the clinical indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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Scientific title
An Open-label, Pilot Efficacy Study and Exploratory Evaluation of the Systemic Bioavailability of Single and/or Multiple Doses of RECCE327 Topical Gel Applied to Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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Secondary ID [1]
312372
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RECCE327-G202
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
334162
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Condition category
Condition code
Infection
330833
330833
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Multi-centre, open-label study to evaluate the potential for systemic bioavailability of single and/or multiple doses of RECCE®327 topical gel into the systemic circulation when applied to acute bacterial skin and skin structure infections (ABSSSI).
The study will also evaluate the safety and tolerability, plasma pharmacokinetics, and efficacy of RECCE®327 topical gel when applied to ABSSSI, after a single dose and multiple doses.
The study will consist of sequential enrolment of up to approximately 30 participants who present with an ABSSSI, and who meet all inclusion criteria and do not meet any exclusion criteria. Participants may be treated in either the outpatient or inpatient setting.
RECCE®327 topical gel will be applied once daily for seven (7) days to the participant's ABSSSI, followed by safety and efficacy evaluations, then a possible additional seven (7) day treatment period, (at investigator recommendation), with repeat safety and efficacy evaluations at the end of the treatment period.
RECCE327 topical gel 4g single use tube. The dose amount will be calculated as follows: weight of tube before application – weight of tube after application = dose amount (g) of RECCE®327 topical gel.
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Intervention code [1]
328871
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Treatment: Drugs
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Comparator / control treatment
No control group.
The study analyses will look at participants response to a single dose of recce (Day 1) assessments and multiple doses (after 7 days of daily treatment), and for participants who have extended treatment (after 14 days of treatment)
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To evaluate the potential for systemic bioavailability of single and multiple doses of RECCE®327 topical gel applied once daily for 7 or 14 days to infected ABSSSI via analysis of plasma concentrations of RECCE®327
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Assessment method [1]
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- Cmax: Maximum plasma concentration
- tmax: Time to Cmax
- tlast: Time to the last observable time point
- AUC0–t: Area under the curve from time of dosing to the last measurable concentration
- AUC0–1: Area under the curve from time of dosing to the 1 hour
- AUC0–2: Area under the curve from time of dosing to the 2 hours (for first dose only).
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Timepoint [1]
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Day 1: Pre-dose and 1.0 hr post-dose.
Day 7 (+/- 3 days): Pre-dose; (~24 hours after the previous dose is applied) 0.5, 1.0, 2.0, and 4.0 hr post-dose (4.0 hr sample to be obtained if participant can stay in clinic).
Day 14 (+/- 3 days) (extended treatment only): Pre-dose (~24 hours after the previous dose is applied) and 1.0 hr post-dose.
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Primary outcome [2]
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To measure the absorption of RECCE327 topical gel
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Assessment method [2]
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PKs will be drawn at the following timepoints:
- Day 1: Pre-dose and 1.0 hr post-dose.
- Day 7 (+/- 3 days): Pre-dose; (~24 hours after the previous dose is applied) 0.5, 1.0, 2.0, and 4.0 hr post-dose (4.0 hr sample to be obtained if participant can stay in clinic).
- Day 14 (+/- 3 days) (extended treatment only): Pre-dose (~24 hours after the previous dose is applied) and 1.0 hr post-dose.
Plasma will be collected at designated timepoints from all participants to calculate the concentration of RECCE®327 and PK parameters.
RECCE®327 PK parameters to be calculated will include:
- Cmax: Maximum plasma concentration
- tmax: Time to Cmax
- tlast: Time to the last observable time point
- AUC0–t: Area under the curve from time of dosing to the last measurable concentration
- AUC0–1: Area under the curve from time of dosing to the 1 hour
- AUC0–2: Area under the curve from time of dosing to the 2 hours (for first dose only).
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Timepoint [2]
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The timepoints are:
- Day 1: Pre-dose and 1.0 hr post-dose.
- Day 7 (+/- 3 days): Pre-dose; (~24 hours after the previous dose is applied) 0.5, 1.0, 2.0, and 4.0 hr post-dose (4.0 hr sample to be obtained if participant can stay in clinic).
- Day 14 (+/- 3 days) (extended treatment only): Pre-dose (~24 hours after the previous dose is applied) and 1.0 hr post-dose.
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Primary outcome [3]
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To evaluate the safety/tolerability of RECCE®327 topical gel applied once daily for 7 or 14 days to infected ABSSSI.
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Assessment method [3]
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Safety evaluations will be based on the incidence, intensity and type of AE and clinically significant changes in the participant’s physical examination findings, vital signs, and clinical laboratory results. Safety variables will be tabulated and presented for all participants who receive RECCE®327 topical gel, i.e., the safety population.
Abnormalities in clinical laboratory tests and vital signs will be based on pre-defined normal ranges and will be tabulated by treatment group showing participant counts and percentages.
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Timepoint [3]
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Baseline (Pre-dose), Day 1, Day 7, Day 14 (extended treatment participants), End of Study
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Secondary outcome [1]
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To evaluate the efficacy of RECCE®327 topical gel on ABSSSI
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Assessment method [1]
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Wound swab samples to evaluate for bacterial culture.
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Timepoint [1]
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Wound swabs will be taken at the following timepoints:
- Day 1 (baseline),
- Day 7
- Day 14
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Eligibility
Key inclusion criteria
- Must be able to read and understand study information sheet and must give voluntary written informed consent prior any study assessment
- Aged 18 years or older at screening, with suitability confirmed by screening assessments.
- Female participants must: a) Be of non-child-bearing potential or surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the Screening Visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or b) All female participants (unless the Investigator assesses them to not be of childbearing potential), must have a negative urine pregnancy test before the first RECCE®327 administration (Day 1). They must agree not to attempt to become pregnant, must not donate ova for a minimum of 30 days after last RECCE®327 administration, and must agree to: Use at least one form of highly effective contraceptive method between signing consent, during the study, and at least 30 days after the last dose of study therapy.
- Male participants must agree to abstain from unprotected sex and sperm donation after signing the consent through 90 days after the last dose of study medication.
- Presence of an ABSSSI. For DFI an infection with an open wound is required (Diabetic Foot Ulcer Scale - Grade 1)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Currently pregnant or breastfeeding/lactating women.
- History of current clinically significant medical history or condition which would preclude participation in the judgment of the Principal Investigator and Sponsor Chief Medical Officer.
- Use of any investigational compound, or dosing in another clinical trial within 30 days or 5 half-lives of the investigational product, whichever is longer, prior to the planned first study drug administration.
- Wounds with exposed tendons or exposed bone.
- Participant is unable to perform wound dressings and administer IP as per protocol, or lacks support person (i.e., home health care) to perform this function.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
19/08/2024
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Actual
19/08/2024
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Date of last participant enrolment
Anticipated
31/01/2025
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Actual
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Date of last data collection
Anticipated
28/02/2025
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Actual
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Sample size
Target
30
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Accrual to date
9
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [2]
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Australian Clinical Research Network - Maroubra
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Recruitment postcode(s) [1]
42801
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3220 - Geelong
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Recruitment postcode(s) [2]
42802
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2035 - Maroubra
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Recruitment postcode(s) [3]
43216
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3149 - Mount Waverley
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Recce Pharmaceuticals Limited
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Recce Pharmaceuticals Limited
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Address
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Country
Australia
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Secondary sponsor category [1]
319003
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None
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Name [1]
319003
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Address [1]
319003
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Country [1]
319003
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/04/2024
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Approval date [1]
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18/06/2024
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Ethics approval number [1]
315548
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Summary
Brief summary
The study is to evaluate the safety and tolerability, plasma pharmacokinetics, and efficacy of RECCE®327 topical gel when applied to Acute Bacterial Skin and Skin Structure Infections. The study will consist of sequential enrolment of up to approximately 30 participants who present with an ABSSSI, and who meet all inclusion criteria and do not meet any exclusion criteria. Participants may be treated in either the outpatient or inpatient setting. RECCE®327 topical gel will be applied once daily for seven (7) days to an ABSSSI, followed by safety and efficacy evaluations, then a possible additional seven (7) day treatment period, with repeat safety and efficacy evaluations at the end of the treatment period.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Eugene Athan
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Address
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Barwon Health, University Hospital Geelong, Ryrie St, Geelong, VIC 3220, Australia
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Country
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Australia
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Phone
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+61342152878
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Julie Charlton
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Address
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Recce Pharmaceuticals Limited, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
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Country
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Australia
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Phone
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+61893629860
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Julie Cahrlton
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Address
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Recce Pharmaceuticals, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
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Country
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Australia
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Phone
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+61893629860
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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