RecruitingPhase 2ACTRN12624000973516

RECCE®327 Topical Gel Study for the clinical indication of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

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)


Sponsor

Recce Pharmaceuticals Limited

Enrollment

30 participants

Start Date

Aug 19, 2024

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Acute bacterial skin infections — including infected wounds, abscesses, and infected diabetic foot ulcers — can be difficult to treat, particularly as more bacteria develop resistance to common antibiotics. RECCE 327 is a novel topical gel antibiotic with a completely different mechanism of action from existing antibiotics, making it potentially effective against resistant bacteria. This study is the first step in evaluating whether this gel is safe, how it is absorbed by the body, and whether it can treat skin infections effectively. Up to 30 participants with acute bacterial skin and skin structure infections will apply RECCE 327 gel once daily to their wound for seven days. Safety and wound healing will be assessed throughout, with the possibility of a further seven days of treatment. The study can be conducted in either an outpatient or inpatient setting. Adults aged 18 or older with an acute bacterial skin infection — including diabetic foot ulcers with an open wound — may be eligible. Women of childbearing potential must use effective contraception. People who are pregnant or breastfeeding, have serious underlying medical conditions, are currently in another clinical trial, have wounds with exposed tendons or bone, or cannot apply dressings themselves (without a carer) are not eligible. The study is run by Recce Pharmaceuticals Limited.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 bacte

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.


Locations(2)

Barwon Health - Geelong Hospital campus - Geelong

NSW,VIC, Australia

Australian Clinical Research Network - Maroubra

NSW,VIC, Australia

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ACTRN12624000973516