Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000301460
Ethics application status
Approved
Date submitted
5/06/2007
Date registered
5/06/2007
Date last updated
21/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of nebulised N-acetylcysteine on sputum quality and diagnostic yield: a randomised, controlled clinical trial
Scientific title
A randomised clinical trial to compare the efficacy of nebulized N-acetylcysteine and normal saline in improving sputum quality and diagnostic yield in patients with chest infections.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sputum quality, chest infections 1845 0
Condition category
Condition code
Respiratory 1939 1939 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose of 5 ml (200mg/ml) of nebulized N-acetylcysteine (intervention).
Intervention code [1] 1804 0
Diagnosis / Prognosis
Comparator / control treatment
Single dose of 5 ml of nebulized normal saline (control).
Control group
Placebo

Outcomes
Primary outcome [1] 2754 0
Proportion of patients producing a sputum sample deemed ‘good quality’ (presence of >25 polymorphonuclear leukocytes and <10 squamous cells per HPF [x1000 magnification field]) as identified by the microbiology laboratory technician
Timepoint [1] 2754 0
Measured within 2 days of sputum being obtained.
Primary outcome [2] 2755 0
Proportion of ‘all’ sputum samples which are ‘positive’ for a predominant organism (ie. one type of organism clearly in greater numbers than other organisms on microscopy [Gram stain] or culture)
Timepoint [2] 2755 0
Measured approximately 1 week after sputum obtained.
Primary outcome [3] 2756 0
Proportion of ‘good quality’ sputum samples which are ‘positive’ for a predominant organism (ie. one type of organism clearly in greater numbers than other organisms on microscopy [Gram stain] or culture)
Timepoint [3] 2756 0
Measured approximately 1 week after sputum obtained.
Secondary outcome [1] 4644 0
Proportion of patients for whom a change in antibiotic regimen is made as a result of the sputum microscopy and/or culture.
Timepoint [1] 4644 0
Measured approximately 1 week after sputum obtained.
Secondary outcome [2] 4645 0
Adverse effects from NAC administration eg. bronchospasm, nausea.
Timepoint [2] 4645 0
Measured within 1 hour of administration of nebulised saline or N-acetyl cysteine.

Eligibility
Key inclusion criteria
Differential diagnosis inclusive of lower respiratory tract infection as determined by the treating physician (eg. cough, fever, pleuritic chest pain, dyspnoea, decreased breath sounds, bronchial breath sounds, crackles on auscultation) ·A sputum sample is to be collected in the ED.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to co-operate or consent due to debility, significant illness, language barriers, altered consciousness (as determined by the ED or study staff)·Refusal to participate·Pregnancy or breast-feeding·Known allergy to NAC·Presence of significant hepatic or renal failure·Presence of other significant co-morbidities eg. HIV, immunocompromised, cystic fibrosis, bronchiectasis·CXR suggestive of TB·Recent hospital admission within the previous 14 days inclusively·Current treatment with >10mg prenisolone daily for more than 1 month inclusively

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A note containing each individual patients allocation will be inside a sealed envelope inside each study pack
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All people invovled with this study will be blinded - patients, people administering the treatment, people assessing the outcomes (eg. adverse events, microscopy) and people analysing the results. Only when all results have been analysed will the randomisation code be broken and the nature of the drug administration will be revealed.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2473 0
3084

Funding & Sponsors
Funding source category [1] 2081 0
Hospital
Name [1] 2081 0
Austin Health
Country [1] 2081 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 1887 0
None
Name [1] 1887 0
nil
Address [1] 1887 0
Country [1] 1887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3872 0
Austin health
Ethics committee address [1] 3872 0
Ethics committee country [1] 3872 0
Australia
Date submitted for ethics approval [1] 3872 0
Approval date [1] 3872 0
20/08/2007
Ethics approval number [1] 3872 0

Summary
Brief summary
We believe that the use of N-acetylcysteine (a known mucolytic) will be useful in improving the diagnostic yield of sputum culture. If this hypothesis is proven, this agent can be recommend for this purpose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27907 0
Address 27907 0
Country 27907 0
Phone 27907 0
Fax 27907 0
Email 27907 0
Contact person for public queries
Name 10993 0
A/Prof David Taylor
Address 10993 0
Emergency Department
Austin Hospital
Studley Road
Heidelberg, VIC 3084
Country 10993 0
Australia
Phone 10993 0
+61 3 9496 4883
Fax 10993 0
03 9496 3380
Email 10993 0
David.Taylor@austin.org.au
Contact person for scientific queries
Name 1921 0
A/Prof David Taylor
Address 1921 0
Emergency Department
Austin Hospital
Studley Road
Heidelberg VIC 3084
Country 1921 0
Australia
Phone 1921 0
+61 3 9496 4883
Fax 1921 0
03 9496 3380
Email 1921 0
David.Taylor@austin.org.au

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.