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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)
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)
Secondary ID [1] 312372 0
RECCE327-G202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Bacterial Skin and Skin Structure Infection (ABSSSI) 334162 0
Condition category
Condition code
Infection 330833 330833 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328871 0
Treatment: Drugs
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)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338605 0
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
Timepoint [1] 338605 0
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.
Primary outcome [2] 338878 0
To measure the absorption of RECCE327 topical gel
Timepoint [2] 338878 0
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.
Primary outcome [3] 339024 0
To evaluate the safety/tolerability of RECCE®327 topical gel applied once daily for 7 or 14 days to infected ABSSSI.
Timepoint [3] 339024 0
Baseline (Pre-dose), Day 1, Day 7, Day 14 (extended treatment participants), End of Study
Secondary outcome [1] 437111 0
To evaluate the efficacy of RECCE®327 topical gel on ABSSSI
Timepoint [1] 437111 0
Wound swabs will be taken at the following timepoints:
- Day 1 (baseline),
- Day 7
- Day 14

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/08/2024
Actual
19/08/2024
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
30
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 26753 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [2] 26789 0
Australian Clinical Research Network - Maroubra
Recruitment postcode(s) [1] 42802 0
2035 - Maroubra
Recruitment postcode(s) [2] 43216 0
3149 - Mount Waverley
Recruitment postcode(s) [3] 42801 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 316780 0
Commercial sector/Industry
Name [1] 316780 0
Recce Pharmaceuticals Limited
Country [1] 316780 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Recce Pharmaceuticals Limited
Address
Country
Australia
Secondary sponsor category [1] 319003 0
None
Name [1] 319003 0
Address [1] 319003 0
Country [1] 319003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315548 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315548 0
Ethics committee country [1] 315548 0
Australia
Date submitted for ethics approval [1] 315548 0
24/04/2024
Approval date [1] 315548 0
18/06/2024
Ethics approval number [1] 315548 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135046 0
Prof Eugene Athan
Address 135046 0
Barwon Health, University Hospital Geelong, Ryrie St, Geelong, VIC 3220, Australia
Country 135046 0
Australia
Phone 135046 0
+61342152878
Fax 135046 0
Email 135046 0
eugene.athan@barwonhealth.org.au
Contact person for public queries
Name 135047 0
Julie Charlton
Address 135047 0
Recce Pharmaceuticals Limited, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
Country 135047 0
Australia
Phone 135047 0
+61893629860
Fax 135047 0
Email 135047 0
julie.charlton@recce.com.au
Contact person for scientific queries
Name 135048 0
Julie Cahrlton
Address 135048 0
Recce Pharmaceuticals, Suite 10, 3 Brodie Hall Drive, Technology Park, Bentley WA 6102
Country 135048 0
Australia
Phone 135048 0
+61893629860
Fax 135048 0
Email 135048 0
julie.charlton@recce.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.