The effects of nebulised N-acetylcysteine on sputum quality and diagnostic yield: a randomised, controlled clinical trial

Phase 3

Completed

• Conditions: Sputum quality, chest infections; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12607000301460
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 190

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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[Measured within 2 days of sputum being obtained.];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)[Measured approximately 1 week after sputum obtained.];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)[Measured approximately 1 week after sputum obtained.]

Secondary Outcome Measures

Name	Time	Method
Proportion of patients for whom a change in antibiotic regimen is made as a result of the sputum microscopy and/or culture. [Measured approximately 1 week after sputum obtained.];Adverse effects from NAC administration eg. bronchospasm, nausea. [Measured within 1 hour of administration of nebulised saline or N-acetyl cysteine.]