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. 2018 Sep 5;2018(9):CD012590. doi: 10.1002/14651858.CD012590.pub2

Lam 1986.

Methods Aims: to compare the effectiveness of oral amoxicillin and oral ofloxacin for infective exacerbations in non‐cystic fibrosis bronchiectasis
Design: randomised, double‐blind, double‐dummy placebo‐controlled trial
Total study duration: not reported
Number of study centres and locations: single, Hong Kong
Study setting: hospital
Methods of recruitment: not reported
Withdrawals: none
Study start and end dates: not reported
Analysis by intent‐to‐treat: not reported
Participants 32 adults were randomised.
Inclusion criteria: hospitalised adult patients with an infective exacerbation of bronchiectasis
Exclusion criteria: past history of allergy to antibiotics, hepatic or renal dysfunction, or pregnancy
Mean age: ofloxacin (OG): 53.6 years; range: 29 to 74; amoxicillin (AG): 54.7 years; range: 43 to 65
Gender: OG: 7 females, 8 males; AG: 7 females, 10 males
Bronchiectasis diagnosis: not reported
Severity of condition: not reported
History of bronchiectasis, years (mean): OG: 15.3 years; range: 3 to 60; AG: 16.2 years; range: 2 to 50
Mean episodes of exacerbations per patient in previous year requiring antibiotics: not reported
Sputum production daily between exacerbations (n): not reported
Baseline lung function mean (SD): not reported
Smoking history: current: OG: 2; AG: 2; former: OG: 5; AG: 7; non‐smoker: OG: 8; AG: 8
Baseline imbalances: none reported
Interventions Treatment started from the day of admission to hospital
OG: ofloxacin plus amoxicillin placebo tablets (n = 15)
Dose: 200 mg; delivery mode: oral; frequency: 3 times daily; duration: 10 days
Co‐intervention: postural drainage and other prescribed treatment including bronchodilators as required
AG: amoxicillin plus ofloxacin placebo tablets (n = 17)
Dose: 1000 mg; delivery mode: oral; frequency: 3 times daily; duration: 10 days
Co‐intervention: postural drainage and other prescribed treatment including bronchodilators as required
Outcomes Temperature, sputum appearance and volume, haemoptysis, cough and dyspnoea: daily
Spirometry and chest radiology: days 0 and 10
Haematological and biochemical tests, and sputum for gram smears and cultures: days 0, 5, and 10. Antibiotic levels in serum and sputum at 2 hours post dosage determined by a disc‐plate bioassay: day 5. Sputum purulence: day 10
Notes Power calculation: 170 children (85 per arm), providing 90% power (α = 0.05, 1‐sided) with 20% non‐inferiority margin to detect 80% resolution rate by day 21
Trial registration: ANZCTR; ACTRN12612000010897
Funders: Daiichi Seiyaku Co Ltd provided the active and matched placebo tablets.
Role of the sponsors: not reported
Ethical approval: not reported
Conclusions: the role of oral ofloxacin in infective episodes of bronchiectasis appears to be promising. If confirmed in a larger number of patients, ofloxacin may prove to be a useful antimicrobial in bronchiectasis on an outpatient basis.

AG: amoxicillin group.

OG: ofloxacin group.

SD: standard deviation.