Levofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: a preliminary study.

OBJECTIVE

Uncomplicated pelvic inflammatory disease (PID) is a common disease caused by numerous pathogens: sexually transmitted infections (such as Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium), anaerobes, and other organisms from the vaginal flora. It is currently treated by oral route and most present protocols recommend ofloxacin plus metronidazole (MET). The CDC 2006 Guidelines suggested that levofloxacin (LEV) can be a substitute for ofloxacin. This study aimed to evaluate the efficacy and safety of LEV-MET in the treatment of uncomplicated PID.

METHODS

The first 40 cases of uncomplicated PID were prospectively evaluated (June 2006 to December 2007). Diagnosis was based on the clinical signs and microbial findings. If present (N=8), IUD were removed and cultured. Treatment consisted of LEV 500mg OD+MET 500mg BID by oral route for 14 days. Visits took place at the end of therapy (EOT) and at follow-up (FU) 4-6 weeks later. The endpoints were clinical resolution (at the EOT and FU) and bacteriological eradication (at the EOT).

RESULTS

10 cases of bacterial vaginosis were found and 35 pathogens (E. coli: 12, anaerobes: 5; C. trachomatis: 5; M. hominis: 5; U. urealyticum: 3; others: 5) were isolated in the cervix. 37 patients were evaluable at the EOT: 27 were clinically cured and 10 significantly improved; all pathogens were eradicated. At FU, all 35 evaluable patients were clinically cured. Drug-related adverse events (AEs) occurred in 9 cases: 1 patient discontinued (myalgia and tendonitis) while other AEs consisted of nausea or diarrhea.

CONCLUSIONS

This preliminary study has shown that a 14-day course of oral LEV-MET is effective and well-tolerated in the treatment of outpatients with uncomplicated PID.