A multicentre open clinical trial of teicoplanin in infections caused by gram-positive bacteria.

A multicentre open trial of teicoplanin in 81 centres in nine European countries included 1431 cases: 531 female, 900 male; mean age 49.4 years, range 1-93 years. These were hospitalized patients most of whom had infections caused by Staphylococcus aureus (816 isolates). Of a total of 1427 Gram-positive pathogens 280 (19.6%) were methicillin resistant. There were 536 skin and soft tissue infections, 263 septicaemias, 135 lower respiratory tract infections, 179 joint and bone infections and 83 endocarditides. More than a third of the infections were severe. Complicating medical factors were present in 69% of cases, including malignant disease in 14% and diabetes mellitus in 11%. Mean teicoplanin dose was 289 mg/day; mean duration of treatment was 14 days. A total of 471 patients received a high dose regimen, 400 mg teicoplanin daily for at least five days. Monotherapy with teicoplanin was used in 1037 cases and combination with other antibiotics in 394. Overall 91.7% of the 1333 evaluable cases were clinical cured or improved. The MIC of teicoplanin was less than or equal to 1 mg/l for 90% of Gram-positive isolates. Adverse events were reported in 189 cases (13.2%). The most common drug-related event was an allergic type skin reaction which occurred in 35 cases (2.4%). Transient hepatic dysfunction was reported in 28 patients (2.0%).