Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001097538
Ethics application status
Approved
Date submitted
14/09/2015
Date registered
19/10/2015
Date last updated
3/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized trial of the efficacy and rate of relapse of bacterial infections using standard versus symptom-based antibiotic duration in primary-care patients
Scientific title
Randomized trial of the efficacy and rate of relapse of bacterial infections using standard versus symptom-based antibiotic duration in primary care patients.
Secondary ID [1] 287464 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin infections 296187 0
Pneumonia 296188 0
Sinusitis 296189 0
Cystitis 296190 0
Condition category
Condition code
Infection 296467 296467 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The antibiotic course will be stopped when the patient's symptoms have substantially subsided. The investigators will advise the patient when to stop antibiotics, based on symptoms scores assessed daily while taking antibiotics. The criteria for stopping antibiotics, based on a symptom severity score of 1 (very mild) to 10 (most severe) will be all of the following:
1. More than 3 days after onset of symptoms
2. Symptom score 2 or less for feverishness (chills, sweats) and pain
3. Symptom score 3 or less or back to baseline for loss of appetite, body ache, skin symptoms/signs (redness, heat, swelling - if skin infection), urinary symptoms (dysuria, frequency - if urinary infection), cough improving (if chest infection), less than 50% volume of purulent sputum (if chest infection), less than 50% volume of nasal discharge or post-nasal drip (if sinus infection)
4. The patient feels ready to stop antibiotics.

Adherence will be checked each day during antibiotic treatment.
Intervention code [1] 292840 0
Treatment: Drugs
Comparator / control treatment
Antibiotic course will be of standard duration
Control group
Active

Outcomes
Primary outcome [1] 296094 0
Response to antibiotic treatment, assessed by daily symptom score.
Timepoint [1] 296094 0
End of treatment
Primary outcome [2] 296095 0
Relapse of infection, assessed by symptom score at follow up, by restarting of antibiotics and for urine infection by relapse or persistence of positive urine culture.
Timepoint [2] 296095 0
Day 5 to 7 after treatment stopped and day 14 to 21 after treatment stopped
Secondary outcome [1] 317478 0
Treatment-emergent adverse events, such as nausea, vomiting, diarrhoea or skin rash. The patient will be asked about TEAE by the study team at each contact.
Timepoint [1] 317478 0
Each day during the period of antibiotic treatment and at each follow-up assessment (between days 5 to 7 after treatment finishes and between days 14 and 21 after treatment finishes).
Secondary outcome [2] 318057 0
Total consumption of antibiotic doses, assessed by telephone questioning
Timepoint [2] 318057 0
Daily phone call during antibiotic treatment

Eligibility
Key inclusion criteria
Outpatients only
Skin infection - surface area > square 75 cm
Pneumonia - using scoring system from local acute cough algorithm
Sinusitis - criteria for antibiotic treatment from Australian Therapeutic Guidelines 2014
Bladder infection - compatible symptoms plus bacteruria
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe infections or hospitalised patients.
Substantial immune compromise
Treatment failure for same infection in past 3 months
Other antibiotic treatment within 4 days of enrolement.
Infection found to be caused by bacteria resistant to those prescribed
Skin infection requiring more complex or prolonged treatment, such as necrotising infection, diabetic foot infections or infection complicating severe peripheral vascular disease, decubitus ulcer infection, animal or human bite infection, infection complicating fresh water or salt water trauma, or infection associated with a vascular, enteric or urinary catheter site, underlying osteomyelitis or septic arthritis, or a recent deep surgical wound.
Chest infections requiring more complex or prolonged treatment, such as infective exacerbations of bronchiectasis or cystic fibrosis, empyema.
Sinus infection involving the orbit or intra-cranial structures
Pyelonephritis, prostatitis or indwelling urinary catheter

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)
The GP or ED doctor will contact the study team with a possible recruit. The doctor will prescribe antibiotics according to local protocols (which are highlighted and promoted for patients treated during the study period). Patients interested in being included in the study will be given written information then contacted and visited to discuss being in the trial. Subjects will be randomised to either symptom-based or standard antibiotic duration according to pre-generated sequences. Allocation will be performed by the principal investigator and will be concealed from the GP, patient and research assistant until it has been determined that the patient meets the criteria for the trial and has consented to being part of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation in blocks, stratified by infection type. Used www.random.org – integer sets.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two arms
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
9/11/2015
Actual
20/11/2015
Date of last participant enrolment
Anticipated
Actual
27/01/2016
Date of last data collection
Anticipated
21/02/2016
Actual
21/02/2016
Sample size
Target
200
Accrual to date
Final
71
Recruitment outside Australia
Country [1] 7164 0
New Zealand
State/province [1] 7164 0

Funding & Sponsors
Funding source category [1] 292036 0
Charities/Societies/Foundations
Name [1] 292036 0
Nelson Medical Research and Education Trust Fund
Country [1] 292036 0
New Zealand
Primary sponsor type
Government body
Name
Nelson Bays Primary Health
Address
PO Box 1776
Nelson 7040
Country
New Zealand
Secondary sponsor category [1] 290706 0
Charities/Societies/Foundations
Name [1] 290706 0
Nelson Medical Research and Education Trust
Address [1] 290706 0
c/o Dr Bruce King
Medical Outpatient Clinic
Nelson Hospital
Private Bag 18
Nelson 7010
Country [1] 290706 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293522 0
Health and Disability Ethics Committees
Ethics committee address [1] 293522 0
Ethics committee country [1] 293522 0
New Zealand
Date submitted for ethics approval [1] 293522 0
06/10/2015
Approval date [1] 293522 0
13/11/2015
Ethics approval number [1] 293522 0

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

Contacts
Principal investigator
Name 60298 0
Dr Richard Everts
Address 60298 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 60298 0
New Zealand
Phone 60298 0
+64 274633284
Fax 60298 0
Email 60298 0
[email protected]
Contact person for public queries
Name 60299 0
Richard Everts
Address 60299 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 60299 0
New Zealand
Phone 60299 0
+64 274633284
Fax 60299 0
Email 60299 0
[email protected]
Contact person for scientific queries
Name 60300 0
Richard Everts
Address 60300 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 60300 0
New Zealand
Phone 60300 0
+ 64 274633284
Fax 60300 0
Email 60300 0
[email protected]

No information has been provided regarding IPD availability


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.