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Levofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: a preliminary study
Philippe Judlin1, Olivier Thiebaugeorges
1Department of Obstetrics, Gynecology & Reproduction, Maternite Regionale Universitaire, University Henri-Poincare, Nancy, France. p.judlin@maternite.chu-nancy.fr
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.
Study Design:
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.
Conclusion:
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.
Insights
This study shows that a 14-day oral treatment of levofloxacin (LEV) plus metronidazole (MET) is effective for uncomplicated pelvic inflammatory disease (PID). The LEV-MET regimen demonstrated high clinical cure rates and pathogen eradication, with good tolerability in outpatients.
Area of Science:
- Infectious Diseases
- Gynecology
- Pharmacology
Background:
- Uncomplicated pelvic inflammatory disease (PID) is a common condition with diverse causative pathogens, including sexually transmitted infections and vaginal flora.
- Current oral treatment protocols often involve ofloxacin plus metronidazole (MET).
- Levofloxacin (LEV) has been suggested as an alternative to ofloxacin in treatment guidelines.
Purpose of the Study:
- To evaluate the efficacy and safety of a combined oral regimen of levofloxacin (LEV) and metronidazole (MET) for treating uncomplicated PID.
- To assess clinical resolution and bacteriological eradication rates.
- To document drug-related adverse events associated with the LEV-MET treatment.
Main Methods:
- A prospective study evaluated 40 patients diagnosed with uncomplicated PID.
- Treatment consisted of oral levofloxacin 500mg once daily plus metronidazole 500mg twice daily for 14 days.
- Clinical and microbiological endpoints were assessed at the end of therapy (EOT) and at a 4-6 week follow-up (FU).
Main Results:
- Pathogen identification revealed common culprits including E. coli, anaerobes, Chlamydia trachomatis, Mycoplasma hominis, and Ureaplasma urealyticum.
- At EOT, 37 patients were evaluable, with 27 achieving clinical cure and 10 showing significant improvement. All identified pathogens were eradicated.
- At FU, all 35 evaluable patients achieved clinical cure. Adverse events occurred in 9 cases, with one discontinuation due to myalgia and tendonitis.
Conclusions:
- A 14-day oral course of levofloxacin plus metronidazole (LEV-MET) is effective for treating uncomplicated PID in an outpatient setting.
- The LEV-MET regimen demonstrated high rates of clinical cure and pathogen eradication.
- The treatment was generally well-tolerated, with a low incidence of significant adverse events.
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