None listed
Conditions
Brief summary
Acute bronchitis is the 5th most frequent reason to visit a general practitioner (GP), often leading to an antibiotic prescription even though guidelines advise that the infective organism is usually viral. Patient factors are partially responsible for these prescriptions but research indicates that GPs are inconsistent in their labelling of acute bronchitis and may feel the need to use antibiotics “just in case”. Studies indicate that, overall, patients with acute bronchitis may experience only a marginal benefit from antibiotic treatment, and this benefit may be offset by potential side effects. A recent Cochrane systematic review suggests that some patients may benefit from antibiotics. Based on clinical symptoms, signs and investigations, we think there may be two groups of patients with acute bronchitis - ‘uncomplicated’ and ‘complicated’- the former not requiring antibiotics and the latter, associated with poorer outcomes, who might benefit from their use. By identifying those sub-groups, GPs could be more certain about who to treat (and therefore who not to treat) leading to more rational and cost effective prescribing without compromising patient care. This is a double blind study which means that the patients have been randomly assigned to recieve either amoxycillin or placebo capsules for 6 days, and neither the patients nor the physicians or trial staff know which treatment has been allocated until database close.
Interventions
500 mg amoxycillin capsules. Oral dose taken three times a day for 6 days.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) presenting with an acute cough of less than 14 days, 2) at least one other symptom of a respiratory tract infection (sputum production, dyspnoea, wheeze, chest discomfort/pain), 3) at least one 'complicated' acute bronchitis sign (pulse rate >100, respiratory rate >25, oral temperature >38ºC, abnormal chest signs, age >55, confined to bed/very unwell, co-morbidity), 4) have read the patient information sheet and provided written consent, 5) able and willing to follow study requirements.
Exclusion criteria
1) a concurrent chronic respiratory illness that requires ongoing treatment, 2) antibiotics in the previous 3 weeks, 3) immunocompromised, 4) allergic to amoxycillin, penicillin, cephalospirins or beta-lactams, 5) lactose intolerant, 6) community acquired pneumonia, 7) bordatella pertussis.
Outcome results
None listed