EVALUATION OF NEW ANTIINFECTIVE DRUGS FOR THE TREATMENT OF VASCULAR ACCESS DEVICE ASSOCIATED BACTEREMIA AND FUNGEMIA

For clinical trials of anti-infective drugs for the treatment of vascu lar access device-related bloodstream infections, patients should be i dentified and enrolled on the basis of current standards for the clini cal diagnosis of such infections. To ensure comparability of patients, only those infected with staphylococci and Candida species should be included. A prospective, randomized, double-blind design is recommende d. Future protocols may include abbreviated courses of therapy, treatm ent with combinations of drugs, or a progression from parenteral to or al therapy. Clinical response is judged as cure, failure, or indetermi nate response; there is no ''improved'' category. Microbiological resp onse is categorized as eradication, persistence, or relapse and is of paramount importance. Several months of follow-up may be necessary for the detection of late relapses or metastatic infections. This guideli ne does not apply to studies of bacteremia or fungemia secondary to no n-device-related, organ-based primary infections (e.g., pneumonia, uri nary tract infection), which should be assessed in relation to the pri mary disorder.