Based on its in-vitro activity against the majority of organisms associated with bacterial
prostatitis and its excellent penetration into prostatic tissue, prostatic secretions and seminal fluid,
temafloxacin appears to be a suitable agent for the treatment of prostatic
infections. The efficacy and safety of
temafloxacin 400 mg bd for 28 days were assessed in 61 patients from ten centres in Germany with symptomatic bacterial
prostatitis diagnosed by segmented localizing cultures. Urine and prostatic secretions were obtained for culture. Clinical signs and symptoms were evaluated at two weeks during treatment, and at 5 to 9 days and 26 to 30 days
after treatment. Safety was monitored during and at the end of treatment. Escherichia coli and Enterococcus spp. were the most frequent pathogens. In 41 clinically and bacteriologically evaluable patients, 37 (90%) were successfully treated at 5 to 9 days; four of these patients did not return for follow-up at the final visit and the remaining patients (33) continued to be clinically cured or improved. Thirty-seven patients (90.2%) had eradication of pre-treatment pathogens at 5 to 9 days
after treatment; three of these patients did not return for this final follow-up visit. There were six patients with persistent or recurrent pathogens isolated and six patients with reinfecting pathogens. Thus, 26 of 38 (68%) evaluable patients at visit 5 were free from
infection (from either a pre-treatment pathogen or any subsequent new infecting pathogen) up to 26 to 30 days
after treatment. One clinically evaluable but bacteriologically non-evaluable patient was classified as a therapeutic failure after nine days of treatment and was not included in the final assessment. Improvement in the severity of specific signs and symptoms was observed in greater than 90% of cases. Mild to moderate adverse events, mostly occurring during the first or second weeks of long-term
therapy, were reported in 11.5% of patients.
Temafloxacin 400 mg bd, for four weeks was very effective and well tolerated by the majority of patients with documented bacterial
prostatitis.