Evaluation of fleroxacin (RO 23-6240) as single-oral-dose therapy of culture-proven chancroid in Nairobi, Kenya

Abstract

Chancroid is gaining importance as a sexually transmitted disease because of its association with transmission of human immunodeficiency virus type 1 (HIV-1). Effective, simply administered therapy for chancroid is necessary. Fleroxacin is effective against Haemophilus ducreyi in vitro. We performed an initial randomized clinical trial to assess the efficacy of fleroxacin for treatment of chancroid in Nairobi, Kenya. Fifty-three men with culture-positive chancroid were randomly assigned to receive either 200 mg (group 1) or 400 mg (group 2) of fleroxacin as a single oral dose. Groups 1 and 2 were similar with regard to severity of disease, bubo formation, and HIV-1 status. A satisfactory clinical response to therapy was noted in 23 of 26 patients (88%) in group 1 and 18 of 23 patients (78%) in group 2. Bacteriological failure occurred in 1 of 26 evaluable patients (4%) in group 1 and 4 of 23 evaluable patients (17%) in group 2. Two of 37 HIV-1-seronegative men (5%) and 3 of 11 HIV-1-infected men (27%) were bacteriological failures. Fleroxacin, 200 or 400 mg as a single oral dose, is efficacious therapy for microbiologically proven chancroid in patients who do not have concurrent HIV-1 infection. Among HIV-1-infected men, a single dose of 200 or 400 mg of fleroxacin is inadequate therapy for chancroid.

Pharmacokinetics of [18F]fleroxacin in healthy human subjects studied by using positron emission tomography

“…Animal studies have suggested that there is excellent penetration of drug into most tissues (5, 18, 30-34, 41, 49, 53), but only limited information on tissue penetration of fleroxacin in humans is available (22,26,41,44,53). Initial clinical experience in the treatment of sexually transmitted diseases, urinary tract infection, skin and soft tissue infections, gastrointestinal infection, and even acute exacerbations of chronic bronchitis has been quite promising, with 74 to 100% bacteriological cure rates and a tolerability comparable to those for other drugs of this class (3,12,27,35,38,42,43,45,47). However, to optimize the clinical use of * Corresponding author.…”

Treatment of chancroid

“…The quinolones rosoxacin, ciprofloxacin, enoxacin, norfloxacin, and fleroxacin have all proved to be effective in the treatment of chancroid (1,3,4,15,23,25,26). Although some of these agents have been found to be effective following single-dose administration, the efficacy of such (23).…”

“…Although some of these agents have been found to be effective following single-dose administration, the efficacy of such (23). Sulfonamide-trimethoprim combinations have also become established as one of the treatments of choice for the disease in many areas.…”

Mining the Proteome of Haemophilus ducreyi for Identification of Potential Drug Targets

“…Centers for Disease Control and Prevention (CDC) recommend azithromycin, ceftriaxone and erythromycin for the treatment of chancroid [16]. However, single-dose treatment by these drugs was found not to be successful in more than 20% of chancroid therapies [17][18][19]. Furthermore de novo mutations and horizontal gene transfer mechanism in H. ducreyi may lead to development of drug resistance genes [17,20].…”