Respir Med. 1993 Nov;87(8):587-93.

Double-blind RCT. Parallel design.

40 randomised. 31 completed the trial. Mean age (sd) of 15 participants in the active treatment group: 28.3 years (6.06 years) Mean age (sd) of 16 participants in the placebo group: 24.9 years (5.15 years) Eligible if over 18 years of age and chronically infected with P. aeruginosa. Participants were excluded from the trial if they had P. aeruginosa resistant to CPX in their sputum culture immediately prior to entering the trial, renal insufficiency, an int Sex: active treatment group: 13 males, 2 females; placebo group: 10 males, 6 females. Country: UK

CPX (500 mg) tds or an identical placebo for 10 days every 3 months for 4 courses. Time-points reported in the trial: baseline; day 10 (every 3 months) for MIC only; final assessment. Time-points when measurements were taken during the trial: baseline; every 3 months up to 12 months.

At each visit the participants' clinical symptoms, signs, weight and drug history were recorded*. FEV1* Mortality Adverse effects* FVC* PEF Oxygen saturation Diary card completed listing details of symptoms, sputum volume and PEF. Sputum volume was recorded using a 5-point scale. Sputum samples were cultured at the start and finish (day 10) of each course of tablets. Sputum specimens were collected at each outpatient visit and at the end of each treatment period. Susceptibility of isolates of P. aeruginosa were stored for analysis of MIC at the end of the trial period. Breathlessness was graded by the participants using a 3-point scale*.

During each course of treatment patients receiving ciprofloxacin reported an improvement in cough, sputum production and peak expiratory flow (PEF) P = < 0.005. During the year of study patients receiving ciprofloxacin showed an improvement in PEF when compared with those receiving placebo (P = < 0.05) but the changes in FEV1 and FVC were not statistically different in either group. Regular oral ciprofloxacin was well tolerated but did not prevent hospital admissions or reduce the number of courses of intravenous antibiotics throughout the year. The median MIC to ciprofloxacin in the active treatment group rose from 0.5 mg l-1 to 0.75 mg l-1 during treatment.

CF patients are likely to benefit from oral ciprofloxacin for exacerbations of respiratory symptoms. However, regular treatment with ciprofloxacin over 1 yr improves PEF but does not reduce the rate of hospital admissions with acute exacerbations of respiratory symptoms.

Antibiotic treatment for stenotrophomonas maltophilia in people with cystic fibrosis

Antibiotic treatment of early pseudomonas aeruginosa

Antibiotics for pulmonary exacerbations

Inhaled antibiotics in cystic fibrosis

MRSA eradication in CF

Prophylactic use of oral antistaphylococcal antibiotic

Scheduled antibiotics every 3-4 months / symptom-based treatment