ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621000412831

Ethics application status

Approved

Date submitted

16/02/2021

Date registered

15/04/2021

Date last updated

4/08/2023

Date data sharing statement initially provided

15/04/2021

Date results provided

4/08/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Proof of concept study of RECCE®327 topical antibiotic therapy for infected burn wounds

Scientific title

Proof of concept study of RECCE®327 topical antibiotic therapy for infected burn wounds in adults

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1264-9651

Trial acronym

RECCE®327 PoC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Burn wound

Infection

Condition category

Condition code

Injuries and Accidents

Burns

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Polyacrolein polyethylene glycol oligomer mixture (0.045 gram/gram) will be administered topically as a spray solution to saturate the wound over a 14 day treatment period.

The first ten participants will be allocated to daily application; in practical terms this will mean at least five applications within the first seven days of treatment. The next twenty participants will be allocated to three times a week application. Dressing changes will be aligned with antibiotic application.

During each outpatient clinic visit, the burn wound site will be assessed clinically and study assessments completed. Thereafter, as needed, irrigation and debridement of the wound will be performed in accordance with the standard Burns Unit procedures avoiding chlorhexidine and other cleansing agents with residual effect.

Antibiotic will be administered by a dressing clinic nurse. The antibiotic will be sprayed onto the whole of the infected burn ulcer until the wound is visibly wet/saturated throughout. The wound will be then left open until visibly dried or for at least five minutes before applying a dressing. This will be to ensure adequate absorption of the topical antibiotic into the burn wound bed, to prevent immediate uptake into dressings and maximise the clinical efficacy of this antimicrobial preparation. The wound will then be covered using a standard foam dressing.

Adherence to the intervention will be monitored with records of the number of dressings attended, the number of antibiotic administrations and the number of pumps delivered.

All the procedures, including opening the wound, irrigation, debridement, the preparation and application of the topical antibiotic, and re-dressing, should take approximately 15 min to complete.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Infection status of wound determined by unblinded clinical investigator using the consensus clinical criteria of the International Wound Infection Institute

Timepoint [1]

day 14 post-commencement of intervention

Secondary outcome [1]

Incident adverse signs or symptoms observed by unblinded clinical investigator

Timepoint [1]

day 28 post-commencement of intervention

Eligibility

Key inclusion criteria

(a) patients equal to or over 18 years of age;
(b) patients with clinical signs and symptoms of local wound infection;
(c) patients without any other investigational specialised wound care material other than the topical RECCE®327 applications;
(d) patients anticipated to have a minimum follow-up period of 1 month.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(a) Unable to provide informed consent
(b) Deep structures (bone or tendon) on view
(c) Signs or symptoms of spreading or systemic infection (IWII criteria)
(d) Pregnant or breastfeeding
(e) Known allergy to any components of the RECCE®327 solution or any of its excipients, including: polyethylene glycol (PEG) 200, the active oligomer (4.76%; [7.80% TM001]), acrolein monomer (0.189ppm), and conjugated carbonyls (1.15 ABS @ 230 nm, & 0.75 ANS @ 272nm).

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 1

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Statistical analysis will be descriptive providing details of the clinical characteristics and microbiology of the infected wounds as well as the outcomes (clinical or toxicity) at the end of therapy, and also 2 weeks thereafter. Analysis of the primary outcome will be conducted using all participants that have received at least one dose of the study drug. Pre-defined sub-group analysis will separate (1) daily and three times a week dosing intervals; (2) early and late burn wound infections with late being greater than 6 weeks from date of injury. We consider a desirable outcome of this novel therapy to be at least 70% complete response, which would be a clinically significant improvement to the previously reported 50% response rate.

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

1/06/2021

Actual

20/09/2021

Date of last participant enrolment

Anticipated

1/12/2022

Actual

27/04/2022

Date of last data collection

Anticipated

31/12/2022

Actual

18/05/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Fiona Wood Foundation

Address [1]

Fiona Stanley Hospital, CD15, Level 4, Burns Unit, 11 Robin Warren Drive Murdoch WA 6150

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Recce Pharmaceuticals Ltd

Address [2]

Level 25, 88 Phillip Street Aurora Place SYDNEY NSW 2000

Country [2]

Australia

Primary sponsor type

Government body

Name

South Metropolitan Health Service

Address

14 Barry Marshall Parade, Murdoch WA 6150

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service HREC

Ethics committee address [1]

South Metropolitan Health Service Executive
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/10/2020

Ethics approval number [1]

Summary

Brief summary

Burn wound infections continue to cause significant health problems for patients following a range of burn injuries. Current therapeutic options are sub-optimal and are often associated with delayed wound healing. We therefore plan to study the antibiotic, RECCE®327  to assess the clinical effectiveness and safety of this agent for the treatment on infected chronic burn ulcers. The study is exploratory and will deliver the new RECCE®327 antimicrobial via an innovative spray-on formulation, specially developed for this study.  We plan to study two dosing schedules with ten participants receiving daily and a further twenty receiving three times a week application of the spray-on RECCE®327 antibiotic, over a 14 day study period. If this exploratory study suggests clinical effectiveness and no toxicity signal, we then plan to undertake a much larger study of the novel RECCE®327 antibiotic comparing it to standard care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Edward Raby

Address

Fiona Stanley Hospital 11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 8 6152 0319

Fax

[email protected]

Contact person for public queries

Name

Edward Raby

Address

Fiona Stanley Hospital 11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 8 6152 0319

Fax

[email protected]

Contact person for scientific queries

Name

Edward Raby

Address

Fiona Stanley Hospital 11 Robin Warren Dr, Murdoch WA 6150

Country

Australia

Phone

+61 8 6152 0319

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• They will be available to researchers who provide a methodologically sound proposal that has been reviewed by a health research ethics committee or recognised equivalent.

Conditions for requesting access:
• -

What individual participant data might be shared?

• The study protocol, participant information sheet and consent form as well as all de-identified individual participant data collected in the electronic case report form will be made available.

What types of analyses could be done with individual participant data?

• The scope of secondary analysis will be limited to the approved proposal.

When can requests for individual participant data be made (start and end dates)?

From:
These documents and data will be available beginning 3 months and ending 5 years after publication of the primary study analysis in a peer reviewed medical journal.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Initial request should be made to the principal investigator: [email protected]

A data transfer agreement between the requestor and South Metropolitan Health Service will be required.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Six participants were enrolled and commenced trial... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically