Safety and efficacy of tigecycline in complicated and uncomplicated pelvic inflammatory disease

A. Perutelli, C. Tascini, L. Domenici, S. Garibaldi, C. Baroni, E. Cecchi, M.G. Salerno

2nd Unit Obstetrics and Gynecology Santa Chiara University Hospital, Pisa, Italy. lavinia.domenici@uniroma1.it

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• Pharmacology

OBJECTIVE: Tigecycline is a glycylcycline antimicrobial structurally related to minocycline, with a wide spectrum of activity that includes anaerobes and typical and atypical microorganisms causing pelvic inflammatory disease (PID). This study aimed to evaluate efficacy and safety of tigecycline in complicated PID and un-complicated PID after the failure of first-line antibiotic therapy.

PATIENTS AND METHODS: Between May 2014 and April 2016 at the 2nd Unit of Obstetrics and Gynecology, Santa Chiara Hospital of Pisa a pilot study on 20 women with mild/moderate PID after the failure of first-line antibiotic therapy and on 8 women with complicated PID was conducted. The treatment protocol was 10-day course of tigecycline, with a loading dose of 100 mg intravenously (i.v.) at day one and then 50 mg IV twice daily. The primary endpoint was to evaluate tigecycline’s efficacy in terms of clinical response to test-of-cure (TOC) at the end of therapy and 30 days after the last dose. Clinical response during therapy and safety were analyzed as well.

RESULTS: A total of 28 women were enrolled, and 25 patients completed the study protocol, because 3 patients reported adverse drug effects resulting in treatment interruption. PID was mainly caused by Chlamydia, Gardnerella, Mycoplasma/Ureaplasma. Tigecycline showed a 100% remission of signs and symptoms in patients resistant to first-line antibiotic regimen and in patients with complicated PID. Moreover, tigecycline showed good tolerability and compliance.

CONCLUSIONS: Despite the limited sample size, tigecycline seemed an effective and safe treatment for women with complicated/resistant PID. Nevertheless, further clinical trials are needed to confirm these results.

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