A randomized, double-blind, placebo-controlled trial of single-dose ciprofloxacin versus erythromycin for the treatment of chancroid in Nairobi, Kenya.

A randomized, double-blind, placebo-controlled clinical trial was conducted in Nairobi, Kenya, to compare single-dose ciprofloxacin with a 7-day course of erythromycin for the treatment of chancroid. In all, 208 men and 37 women presenting with genital ulcers clinically compatible with chancroid were enrolled. Ulcer etiology was determined using culture techniques for chancroid, serology for syphilis, and a multiplex polymerase chain reaction for chancroid, syphilis, and herpes simplex virus (HSV). Ulcer etiology was 31% unmixed chancroid, 23% unmixed syphilis, 16% unmixed HSV, 15% mixed etiology, and 15% unknown. For 111 participants with chancroid, cure rates were 92% with ciprofloxacin and 91% with erythromycin. For all study participants, the treatment failure rate was 15%, mostly related to ulcer etiologies of HSV infection or syphilis, and treatment failure was 3 times more frequent in human immunodeficiency virus-infected subjects than in others, mostly owing to HSV infection. Ciprofloxacin is an effective single-dose treatment for chancroid, but current recommendations for empiric therapy of genital ulcers may result in high treatment failure due to HSV infection.

Single-dose cefixime versus single-dose ceftriaxone in the treatment of antimicrobial-resistant Neisseria gonorrhoeae infection.

Sexually transmitted diseases (STDs) have a significant adverse effect on reproductive and child health worldwide. The control of STDs such as gonorrhea is therefore an absolute priority. Cefixime, an oral third-generation cephalosporin with in vitro activity similar to that of ceftriaxone, may be an effective candidate for the treatment of gonorrhea. The efficacy of a single oral 400-mg dose of cefixime was compared with that of a single intramuscular 250-mg dose of ceftriaxone for the treatment of Neisseria gonorrhoeae urethritis in 190 men and cervicitis in 46 women in Nairobi, Kenya. A bacteriologic cure was recorded in 100% of 63 evaluatable patients treated with ceftriaxone and 118 (98%) of 121 evaluatable patients treated with cefixime. Cefixime, as a single oral dose, is an effective alternative for the treatment of uncomplicated gonococcal urethritis in men and cervicitis in women.

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

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.

PIP: In Kenya, researchers enrolled 53, men aged 18-60 years with chancroid who enrolled at the Nairobi City Council Special Treatment Clinic in a clinical trial to test the efficacy of fleroxacin in clinical Haemophilus ducreyi infections. They randomly allocated the men the group receiving 200 mg of oral fleroxacin or the group receiving 400 mg of oral fleroxacin. 88% of the men receiving 200 mg oral fleroxacin (group 1) experienced either improvement in their clinical status or healing compared to 78% of the men receiving 400 mg oral fleroxacin. 2 of 7 (29%) patients who experienced delayed healing tested positive for HIV-1. 2 of 22 patients (9%) who healed right away were HIV-1 positive. The size of the genital ulcer had the most significant effect on healing time. The mean widest ulcer diameter was 9.5 mm in men who healed quickly while it was 18.5 mm in men who experienced a delay in healing (p .005). Microbiological cure occurred in 92% of men from group 1 and in 83% of those in group 2. The difference in microbiological failure rates of HIV-1 seropositive men and HIV-1 seronegative men approached significance (27% vs. 5%; p = .07). These results showed that a 200 or 400 mg single dose of oral fleroxacin is an efficacious treatment for men with microbiologically confirmed chancroid who are not HIV-1 infected. On the other hand, a single dose of neither 200 or 400 mg of oral fleroxacin adequately treats chancroid in HIV-1 infected men. Further study of chancroid treatment in HIV infected patients is needed, especially since chancroid may facilitate HIV transmission.

Treatment of chancroid with ciprofloxacin. A prospective, randomized clinical trial.

Chancroid is a major sexually transmitted disease in many developing countries. Although single-dose and short-course treatment of chancroid have been described, the increasing resistance of Hemophilus ducreyi to antimicrobial agents requires continuing evaluation of new therapies. Ciprofloxacin is a new quinolone antimicrobial agent with excellent in vitro efficacy against H. ducreyi. A double-blind, randomized clinical trial was conducted comparing a single-dose ciprofloxacin regimen (500 mg) and a three-day regimen of ciprofloxacin (500 mg twice daily) with a three-day regimen of trimethoprim-sulfamethoxazole (160 and 800 mg, respectively, twice daily) for the treatment of chancroid. The three-day ciprofloxacin regimen successfully eradicated H. ducreyi, and resulted in rapid clinical improvement in all 40 patients followed, with no failures. The other two regimens were also effective, but bacteriologic and clinical failure occurred in two and three patients following treatment with single-dose ciprofloxacin and three days of trimethoprim-sulfamethoxazole, respectively. All patients with buboes had resolution of lesions. There were no significant adverse effects associated with ciprofloxacin or trimethoprim-sulfamethoxazole. All three regimens are effective therapy for chancroid and H. ducreyi infections. If resistance to trimethoprim-sulfamethoxazole becomes widespread, ciprofloxacin may become a first-line therapy for chancroid. This study also demonstrates the efficacy of ciprofloxacin in soft tissue infection.

Cefotaxime treatment of Haemophilus ducreyi infection in Kenya.

The authors conducted a double-blind randomized clinical trial comparing single-dose cefotaxime (1 g im) plus daily placebo injections with cefotaxime (1 g im on each of three days). Each regimen was given with probenicid (1 g orally) for the treatment of chancroid. Twenty Haemophilus ducreyi culture-positive men received the single-dose cefotaxime regimen; in eight patients ulcers or buboes failed to respond to therapy. Nineteen H. ducreyi culture-positive men received cefotaxime on each of three days; H. ducreyi was eradicated from all patients, but one had a continuing ulcer and another had a bubo that failed to respond. Thus cefotaxime (1 g im daily for three days) plus probenicid (1 g orally) is effective therapy for chancroid. The lack of efficacy for chancroid of the single-dose cefotaxime regimen is surprising, given the remarkable susceptibility of H. ducreyi to cefotaxime; presumably the half-life of cefotaxime is too short for predictable eradication of H. ducreyi from the ulcer with a single-dose regimen.

Short-course and single-dose antimicrobial therapy for chancroid in Kenya: studies with rifampin alone and in combination with trimethoprim.

Tetracyclines and sulfonamides are no longer effective for the treatment of chancroid in many parts of the world. Rifampin and trimethoprim both possess in vitro activity against Haemophilus ducreyi, the causative agent of chancroid. In a randomized, controlled study, 22 patients with H. ducreyi-positive genital ulcers received 600 mg of rifampin once daily for three days, and 32 patients received 600 mg of rifampin plus 160 mg of trimethoprim once daily for three days. Both regimens rapidly eradicated H. ducreyi from ulcers, with subsequent healing of ulcers and buboes. Two relapses of ulcers and one therapeutic failure were observed in the rifampin-trimethoprim group, whereas no relapses or failures were noted in the rifampin group. In addition, all of 16 H. ducreyi-negative ulcers responded rapidly to treatment with either regimen. In an uncontrolled, open study, 22 H. ducreyi-positive ulcers were treated with a single dose of rifampin (600 mg) plus trimethoprim (160 mg). Ulcers and buboes resolved by day 14 in all but one patient. Thus, these short-course and single-dose regimens are effective against chancroid.