Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000018112p
Ethics application status
Not yet submitted
Date submitted
18/12/2018
Date registered
9/01/2019
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Impact of Azithromycin on Surgical Site Infection Rates
Scientific title
The Impact of Azithromycin on Surgical Site Infection Rates (TIASSIR) in pregnant women undergoing an emergency Caesarean section at Redland Hospital
Secondary ID [1] 296872 0
Nil known/ none
Universal Trial Number (UTN)
U1111-1225-4735
Trial acronym
TIASSIR
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Surgical wound infection 310790 0
Endometritis 310791 0
Maternal Sepsis 310792 0
Condition category
Condition code
Infection 309464 309464 0 0
Studies of infection and infectious agents
Reproductive Health and Childbirth 309539 309539 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group will receive:
1. Intravenous Cefazolin (2g if patient weight at delivery <120kg/ 3g if patient weight at delivery >120kg) AND
2. Intravenous Azithromycin 500mg AND
3. Topical Iodine vaginal preparation
The intravenous antibiotics will be administered, within 15-60 minutes of skin incision (commenced prior to skin incision); the topical iodine will be applied after adequate anaesthesia is achieved but prior to skin incision
Intervention code [1] 313147 0
Prevention
Comparator / control treatment
Control group will receive
1. Intravenous Cefazolin 2g (Pt weight <120kg)/ 3g (Pt weight >120kg) AND
2. Iodine vaginal preparation

(NO Azithromycin)

The intravenous cefazolin will be administered, within 15-60 minutes of skin incision (commenced prior to skin incision); the topical iodine will be applied after adequate anaesthesia is achieved but prior to skin incision
Control group
Active

Outcomes
Primary outcome [1] 308428 0
Infection Rates: Cellulitis vs Endometritis vs Maternal Sepsis vs composite of these with the use of standardized study-specific questionnaires asked of the patient by a member of the research team.
Timepoint [1] 308428 0
3 assessments within 6 weeks of delivery:
- 1x prior to discharge from hospital (in person review) AND
- 1x within 7-14 days of delivery (in person review) AND
- 1x at 6 weeks postnatal (via phone)
Secondary outcome [1] 354937 0
Adverse maternal reaction to antibiotics administered immediately pre-operatively with the use of standardized study-specific questionnaires asked of the patient by a member of the research team.
Timepoint [1] 354937 0
Within 24 hours of antibiotic administration

Eligibility
Key inclusion criteria
Singleton pregnancy AND
Equal to or more than 32 weeks pregnant AND
Emergency lower segment Cesarean section (LSCS) either in labour (defined as regular painful contractions AND progressive cervical dilatation of at least 4cm OR Rupture of Membranes >4 hours OR meeting both criteria)
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Elective lower segment Caesar section OR
Azithromycin/ Iodine/ Cefazolin allergy OR
Inability to provide or declined consent OR
Multiple pregnancy OR
On antibiotics for any other reasons within 7 days of labour OR
Azithromycin/ Iodine/ Cefazolin medically contraindicated

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Use of sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Not applicable
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Using a Statistical significance of 5% along with a 95% confidence interval, a minimum sample size of 385 participants is required.
(http://www.abs.gov.au/websitedbs/D3310114.nsf/home/Sample+Size+Calculator)

Chi-Square statistics to be calculated

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2019
Actual
Date of last participant enrolment
Anticipated
29/02/2020
Actual
Date of last data collection
Anticipated
13/04/2020
Actual
Sample size
Target
385
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12717 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 25142 0
4163 - Cleveland

Funding & Sponsors
Funding source category [1] 301439 0
Hospital
Name [1] 301439 0
Redland Hospital
Country [1] 301439 0
Australia
Primary sponsor type
Hospital
Name
Obstetrics & Gynaecology Department, Redland Hospital
Address
Weippin Street, Cleveland 4163
Queensland
Australia
(Please note, Hospital has no street number attached as per Google search query)
Country
Australia
Secondary sponsor category [1] 301184 0
None
Name [1] 301184 0
N/A
Address [1] 301184 0
N/A
Country [1] 301184 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302173 0
Metro South Hospital and Health Service - Metro South Human Research Ethics Committee
Ethics committee address [1] 302173 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 302173 0
Australia
Date submitted for ethics approval [1] 302173 0
17/01/2019
Approval date [1] 302173 0
Ethics approval number [1] 302173 0

Summary
Brief summary
A randomized controlled trial is designed to assess the impact of Azithromycin in reducing infectious morbidity from emergency cesarean sections at Redlands Hospital. The population undergoing emergency cesarean sections will be the focus of the research project.

Adding Azithromycin to the pre-operative antibiotic regime (of Intravenous Cefazolin and topical Iodine Vaginal Cleansing) is hypothesized to be more effective at reducing post-caesarean section infection rates than the current standard pre-operative antibiotic regime alone.

Trial website
N/A
Trial related presentations / publications
Public notes
N/A

Contacts
Principal investigator
Name 89374 0
Dr Ishani Jayawardena
Address 89374 0
Redland Hospital
Weippin Street, Cleveland 4163
Queensland
Country 89374 0
Australia
Phone 89374 0
+61431946434
Fax 89374 0
N/A
Email 89374 0
[email protected]
Contact person for public queries
Name 89375 0
Dr Wendy Dutton
Address 89375 0
Redland Hospital
Weippin Street Cleveland 4163
Queensland, Australia
Country 89375 0
Australia
Phone 89375 0
+61 7 3488 3111
Fax 89375 0
N/A
Email 89375 0
[email protected]
Contact person for scientific queries
Name 89376 0
Dr Ishani Jayawardena
Address 89376 0
Redland Hospital
Weippin Street Cleveland 4163
Queensland
Country 89376 0
Australia
Phone 89376 0
+61 7 3488 3111
Fax 89376 0
N/A
Email 89376 0
[email protected]

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


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.