Intravenous or sequential ciprofloxacin therapy in hospitalised patients with a broad spectrum of infections: a post-marketing surveillance study.
OBJECTIVE: This study set out to obtain up-to-date information on the efficacy, safety and tolerability of ciprofloxacin as well as the time to improvement and recovery, and to explore data on drug utilisation in hospitalised patients with a special focus on intravenous therapy with ciprofloxacin. METHODS, DESIGN AND PATIENTS: Hospitalised patients with a broad spectrum of infections were included in this non-interventional multicentre study. In order to be included, the patients had to be treated with intravenous ciprofloxacin for a minimum of 2 days. Physicians were advised to pay attention to the contraindications mentioned in the summary of product characteristics. They documented demographic and anamnestic data, the type and severity of the infection, concomitant diseases and medications, the course of clinical and laboratory symptoms, and the treatment. In addition, they rated the overall efficacy of intravenous ciprofloxacin and recorded the time to improvement and recovery. All adverse events were reported. RESULTS: 1012 hospitalised patients with mild to severe clinical infections were included. Their mean age was 61.5 years (SD 16.7), and 57.4% were males. Intravenous ciprofloxacin was given to 28.7% of patients exclusively and 69.6% started with intravenous ciprofloxacin and were switched later to oral treatment. The majority of patients presented with one defined source of infection (77.9%), mainly located in the respiratory tract (40.2%), the abdomen (21.4%), the urinary tract (14.9%) or the kidney (13.4%). Other infections involved the bones and joints (4.5%) or were classified as sepsis (8.0%); 39.6% of infections were classified as severe. Infection symptoms improved in 86.2% of the patients within 5 days. The overall improvement and recovery rates were 91.9% and 85.8%, respectively. Efficacy of ciprofloxacin was judged as 'very good' or 'good' in 86.5% of patients. Tolerability was judged as 'very good' or 'good' in 98.2% of patients. Adverse events occurred rarely and were reported in 2.17% of patients. Seventeen (1.68%) fulfilled the criteria of serious adverse events. In only 0.4% of patients was a relationship between the adverse event and ciprofloxacin treatment suspected. CONCLUSIONS: Intravenous ciprofloxacin is an effective and well tolerated antibacterial treatment in hospitalised patients experiencing a broad spectrum of mild to severe infections.