A comparison of the efficacy and safety of ceftizoxime with doxycycline versus conventional CDC therapies in the treatment of upper genital tract infection with or without a mass
Roy, S.; Wilkins, J.; March, C.M.; Solera, N.C.; Galvan, N.I.; Ressler, R.L.; Cendejas, K.A.; Neal, J.; Azen, C.G.; Essin, D.J.
Clinical Therapeutics 12(Suppl): 53-73
1990
ISSN/ISBN: 0149-2918 PMID: 2202512 Document Number: 358180
It is well known that sexually transmitted infections of the upper genital tract are widespread. A variety of regimens are used to treat these conditions, many of which have not been subjected to randomized, prospective clinical trials (including the 1985 Centers for Disease Control [CDC] Guidelines for the treatment of upper genital tract infections [UGTI]). This investigation was undertaken to compare the 1985 CDC treatment guidelines with different doses of ceftizoxime, a third-generation cephalosporin with an intermediate half-life, plus doxycycline in patients with UGTI. The patients were divided into subgroups, depending on the presence or absence of a pelvic mass. Sixty-seven women participated in the study. They were older than 14 years of age and required hospitalization for the treatment of UGTI. These women had lower abdominal pain and tenderness, cervical motion or adnexal tenderness, and one of the following: temperature >100.4 .degree.F orally, leukocytosis >10,500/mm3, or presence of a suspected inflammatory pelvic mass on pelvic examination or by ultrasound. Informed consent was obtained from all patients in a manner approved by the Institutional Review Board. Pelvic examinations and ultrasound evaluations of the pelvic soft tissues were performed on all patients at the time of admission. Those who were found not to have a pelvic mass or who had a pelvic mass <4 cm in transverse diameter were randomly allocated to receive either certizoxime 2 gm intravenously every 12 hours with doxycycline 100 mg intravenously twice daily (Rx 1, n=13) or cefoxitin 2 gm intravenously every six hours with doxycycline 100 mg intravenously twice daily (Rx 2, n =14). Those patients found to have a pelvic mass (> 4 cm in transverse diameter) were randomly allocated to receive either ceftizoxime 2 gm intravnously every eight hours with doxycycline 100 mg intravenously twice daily (Rx 3, n=19) or clindamycin 900 mg intravenously every eight hours with a 2-mg/kg loading dose of gentamicin followed by 1.5 mg/kg intravenously every eight hours, with adjustments as necessary (Rx 4, n=21). All UGTI patients without a mass treated with either Rx 1 or Rx 2 responded adequately. However, UGTI patients with a mass treated with Rx 4 were more likely than those treated with Rx 3 to require a change in antibiotics or need extirpative surgery in order to obtain a satisfactory clinical response (Fisher's exact test = 0.046, two-sided). The results of this study suggest that ceftizoxime with doxycycline, at the dosages studied, offers an alternative to the conventional CDC guidelines. Depending on the cost of drug(s) and their administration, this therapy may be less costly than and have equal or superior efficacy to the recommended CDC therapies.