ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000249550

Ethics application status

Approved

Date submitted

24/02/2015

Date registered

18/03/2015

Date last updated

12/08/2019

Date data sharing statement initially provided

21/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Antibiotics in acute diverticulitis

Scientific title

Randomised double-blind placebo-controlled trial to evaluate the effect of antibiotics on length of hospital stay in uncomplicated acute diverticulitis in a tertiary hospital setting.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1167-5630

Trial acronym

Linked study record

Health condition

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

Acute diverticulitis

Condition category

Condition code

Surgery

Other surgery

Infection

Studies of infection and infectious agents

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention group will receive intravenous antibiotics followed by oral antibiotics.

Intravenous regimen (to commence following CT confirmation of uncomplicated AD, until afebrile for 24 hours)
Cefuroxime 750mg intravenous, every 8 hours
Metronidazole 500mg intravenous, every 8 hours

Oral antibiotics (on discharge or once afebrile for 24 hours)
Augmentin 625mg per oral, three times a day for 5-7 days
-patients will be telephoned at 30 days and adherence will be examined at this time

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Initial intravenous placebo (containing lactose for colour), followed by tablet placebo (placebo manufactured by external laboratory)

Control group

Placebo

Outcomes

Primary outcome [1]

Length of hospital stay

Timepoint [1]

Hospital discharge from index admission

Secondary outcome [1]

Patient symptom score (Global Symptom Score) and pain scores (on a scale of 1-10 as recorded by nursing staff)
-from patient medical records

Timepoint [1]

First 48 hours in hospital

Secondary outcome [2]

Readmission
-from patient medical records

Timepoint [2]

1 month

Secondary outcome [3]

Need for repeat imaging (CT scan)
-from patient medical records

Timepoint [3]

Throughout index admission

Secondary outcome [4]

Mortality
-from patient medical records

Timepoint [4]

During index admission and 1 month following

Secondary outcome [5]

serum markers of inflammation
-from patient medical records

Timepoint [5]

Throughout index admission

Secondary outcome [6]

Occurrence of complications (need for operation or percutaneous drainage)
-from patient medical records

Timepoint [6]

Throughout index admission

Eligibility

Key inclusion criteria

1. Age > 18 years.
2. Current inpatient under the General Surgery service
3. Diagnosed with uncomplicated acute diverticulitis on CT scan within 24 hours of admission

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Pregnancy.
2. Previous allergic reaction with cefuroxime, metronidazole or amoxicillin/clavulanic acid use
3. Steroid or immunomodulator use for more than 5 days prior to presentation
4. Greater than 1 week of regular, non-steroidal anti-inflammatory drug use prior to presentation
5. Inflammatory bowel disease
6. ASA of 4 or greater
7. CT evidence of complicated disease
8. Meets criteria for a diagnosis of SIRS

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will occur centrally at an external pharmacy where study medications are manfactured. We are working with an external pharmacy that has the capacity to make intravenous placebo. The hospital pharmacy did not have the capacity to make intravenous placebo for non-elective patients

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Screened patients who consent to enrolment in this study will be randomised, with the aim of allowing allocation to the antibiotic and placebo groups in a 1:1 ratio. The actual process of patient randomisation will be achieved using a computer-based random number generator. Heterogeneity will be dealt with by the randomisation process, and post hoc stratification analyses will be undertaken as a secondary outcome.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3 / Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The study investigators have undertaken a retrospective review to enable a well-informed power calculation for this randomised control trial. This review examined all admissions for AD at Auckland City hospital over an 18 month period. There were 204 cases of uncomplicated cases of AD during this time, with a mean length of stay of 88.9hrs (SD 70.6) per episode. 20 of these patients were subsequently found to have had poor outcomes (longer hospital stay or need for procedural intervention). We aim to identify the patients who are at high risk for poorer outcomes through our exclusion criteria, which will slightly reduce our pool of potentially eligible patients.
Using these data, a power calculation was performed in order to determine the number of participants required in order to determine non-inferiority of the intervention. The distribution of these data was symmetric under a logarithmic (base 10) transformation (with SD 0.245).
A change in length of stay of 24 hours would be clinically significant for the patient and for hospital services. Assuming a non-inferiority margin of 24 hours, an independent-samples t-test on log-transformed length of stay data and common SD of 0.245 it was determined that 89 patients would be required in each arm to achieve 80% power and one-sided alpha-error of 0.025 .
We expect the rate of participation to be modest given that this is a trial of acutely unwell patients. After taking rate of participation and the potential for patients to drop-out into account, we aim to recruit 94 patients in each arm – 188 patients in total. As the retrospective study of a single centre carried out over 18 months yielded 204 potentially eligible patients, this is a feasible number to recruit over the same study duration over 3 centres, even after accounting for patients who will be excluded for being at increased risk of poorer outcomes.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/12/2015

Actual

24/12/2015

Date of last participant enrolment

Anticipated

Actual

25/04/2019

Date of last data collection

Anticipated

Actual

25/05/2019

Sample size

Target

188

Accrual to date

Final

180

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Auckland Medical Research Foundation

Address [1]

Ground Floor, 89 Grafton Road
P O Box 110139, Auckland Hospital
Auckland 1148

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Colorectal Surgical Society of Australia and New Zealand

Address [2]

Suite 6, 9 Church Street, Hawthorn, VIC 3122, Australia

Country [2]

Australia

Primary sponsor type

University

Name

University of Auckland

Address

The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Auckland City Hospital

Address [1]

2 Park Road, Auckland 1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 1010

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/02/2015

Approval date [1]

16/06/2015

Ethics approval number [1]

Summary

Brief summary

Aim
To determine whether the administration of an intravenous and oral antibiotic regimen is more effective than a placebo for reducing length of hospital stay, pain and symptoms of uncomplicated AD.

Hypothesis
That patients given the placebo will have a similar resolution of symptoms (as measured by patient reported scores) as those treated with antibiotics without an increase in recurrence or complications.

Primary Objective
To determine whether antibiotic administration results in a difference in length of hospital stay when compared to a placebo.

Secondary Objectives
To determine whether antibiotic administration results in a difference in; patient-reported symptom scores, length of stay, occurrence of complications, readmission within 30 days, symptoms of AD, and serum markers of inflammation when compared with patients receiving placebo.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ian Bissett

Address

Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1023

Country

New Zealand

Phone

+64 21 347 442

Fax

i.bissett@auckland.ac.nz

Contact person for public queries

Name

Rebekah Jaung

Address

Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1023

Country

New Zealand

Phone

+64 21 134 4600

Fax

rebekahjaung@gmail.com

Contact person for scientific queries

Name

Rebekah Jaung

Address

Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1023

Country

New Zealand

Phone

+6421 134 4600

Fax

rebekahjaung@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

individual participant data underlying published results only (de-identified)

When will data be available (start and end dates)?

Following publication of study data for upto 10 years from close of the trial

Available to whom?

case-by-case basis at the discretion of Principal investigator

Available for what types of analyses?

only to achieve the aims in the approved proposal

How or where can data be obtained?

access subject to approvals by Principal Investigator

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

Source	Title	Year of Publication	DOI
Embase	Antibiotics Do Not Reduce Length of Hospital Stay for Uncomplicated Diverticulitis in a Pragmatic Double-Blind Randomized Trial.	2021	https://dx.doi.org/10.1016/j.cgh.2020.03.049

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically