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.