A multicenter clinical trial of Gadolite Oral Suspension as a contrast agent for MRI.

The purpose of this study was to assess the effectiveness and safety of Gadolite Oral Suspension as a gastrointestinal (GI) contrast agent for MRI in a phase II and two phase III multicenter clinical trials. Gadolite was administered to 306 patients with known or suspected abdominal and/or pelvic disease. MRI with T1- and T2-weighted sequences was performed before and after ingestion. Efficacy was evaluated by having two masked readers rate the certainty of their MR diagnosis (0 = uncertain, 1 = probable, 2 = definite) on randomly presented pre- and post-Gadolite Oral Suspension enhanced images. Principal investigators also evaluated the images and established the final diagnosis. Vital signs, clinical chemistries, and adverse events were documented. Blood and urine samples were analyzed for gadolinium content to determine whether Gadolite Oral Suspension was absorbed systemically. Certainty in MR diagnosis increased significantly (P < .001) for both blinded readers between pre- and post-Gadolite images (.49-1.18 for reader 1: .46-1.53 for reader 2). Sensitivity, specificity, and accuracy also increased for both masked readers. No gadolinium was detected in blood or urine samples. There were no serious adverse events and no apparent drug-related trends in mean vital signs or laboratory values. Gadolite is a highly effective, safe, and well tolerated contrast agent for clinical use with MRI.

Efficacy and safety of cefdinir in the treatment of patients with acute bronchitis. The Cefdinir Bronchitis Study Group.

In this randomized, open-label, dose-comparative study, 18 investigators enrolled 466 patients with acute bronchitis. Patients were randomly assigned to receive either 600 mg of cefdinir once daily (QD) or 300 mg of cefdinir twice daily (BID) for 10 days. Both microbiologic and clinical efficacy were assessed at the test-of-cure visit, 7 to 14 days after therapy stopped. A total of 296 patients were classified as assessable at the test-of-cure visit (n = 150 QD, n = 146 BID). Eradication rates of baseline pathogens in these assessable patients were similar in both groups; the baseline pathogen eradication rate for assessable patients in the QD arm was 92%, and that in the BID arm was 93%. Clinical success (cure or improvement) in assessable patients was 91% and 93%, respectively. No difference was seen in the incidence of adverse events, in the incidence of diarrhea, or in the incidence of treatment withdrawals between the two groups. We conclude that cefdinir is effective and safe for the treatment of patients with acute bronchitis.