Itraconazole oral solution as antifungal prophylaxis in children undergoing stem cell transplantation or intensive chemotherapy for haematological disorders

This was an open study of oral antifungal prophylaxis in 103 neutropenic ch ildren aged 0-14 (median 5) years. Most (90%) were undergoing transplantati on for haematological conditions (77% allogeneic BMT, 7% autologous BMT, 6% PBSC transplants and 10% chemotherapy alone). They received 5.0 mg/kg itra conazole/day (in 10mg/ml cyclodextrin solution). Where possible, prophylaxi s was started at least 7 days before the onset of neutropenia and continued until neutrophil recovery. Of the 103 who entered the study, 47 completed the course of prophylaxis, 27 withdrew because of poor compliance, 19 becau se of adverse events and 10 for other reasons. Two patients died during the study and another five died within the subsequent 30 days. No proven syste mic fungal infections occurred, but 26 patients received i.v. amphotericin for antibiotic-unresponsive pyrexia. One patient received amphotericin for mycologically confirmed oesophageal candidosis. Three patients developed su spected oral candidosis but none was mycologically proven and no treatment was given. Serious adverse events (other than death) occurred in 21 patient s, including convulsions (7), suspected drug interactions (6), abdominal pa in (4) and constipation (4). The most common adverse events considered defi nitely or possibly related to itraconazole were vomiting (12), abnormal liv er function (5) and abdominal pain (3). Tolerability of study medication at end-point was rated as good (55%), moderate (11%), poor (17%) or unaccepta ble (17%). Some patients had poor oral intakes due to mucositis. No unexpec ted problems of safety or tolerability were encountered. We conclude that i traconazole oral solution may be used as antifungal prophylaxis for neutrop enic children.