A prospective, randomized, clinical study to compare the clinical safety, effectiveness, and cost of oral ofloxacin/clindamycin vs intravenous clindamycin/gentamicin for the treatment of postpartum endomyometritis.
Objective: The primary objective of this prospective, randomized, clinical study was to compare the safety, clinical and microbiologic efficacy, and cost of oral ofloxacin in combination with clindamycin vs intravenous (IV) clindamycin/gentamicin in the early empiric treatment for hospitalized patients with mild to moderate postpartum endomyometritis. The secondary objective is to reduce total hospital and patient treatment cost. Postpartum endomyometritis is a major cause of infectious morbidity in the obstetric patient. It is the most common complication associated with cesarean delivery. Careful timing and amniotomy, limited vaginal examinations, and prophylactic antibiotics for cesarean section delivery may help to reduce the incidence and severity of endomyometritis. Endomyometritis is caused by bacteria that compose the normal cervicovaginal flora. These are anaerobic gram-positive cocci (Peptostreptococcus and Peptococcus), aerobic streptococci (Group B Streptococci and enterococci), Enterobacteriaceae, Bacteroides (B. fragilis, B. bivius, and B. disiens), and clostridium species.Ofloxacin is a synthetic broad-spectrum antibacterial agent for intravenous and oral administration. Following oral administration, the bioavailability in tablet form is 98% with maximum serum concentrations in 1 to 2 hours. Steady state concentrations are achieved after 4 doses. Ofloxacin usually is bactericidal in action. A synthetic broad-spectrum antibacterial agent for intravenous and oral administration. Ofloxacin inhibits DNA topoisomerase (ATP-hydrolyzing), commonly referred to as DNA-gyrase. DNA-gyrase causes double-stranded DNA breakage; it inhibits duplication, transcription, and repair of bacterial DNA.Methods: This is a preliminary study that has enrolled 19 evaluable patients towards the overall enrollment of 60 patients for statistical significance. Patients clinically diagnosed as having postpartum endomyometritis who meet the inclusion/exclusion criteria were entered into the trial. Patients were examined for the presence of fever (102.2 degrees F), pelvic pain, and foul lochia. A medical history, physical examination, and laboratory analysis were obtained prior to the first dose of antibiotic treatment. A signed consent was obtained prior to the study enrollment and randomization. Appropriate endometrial, blood, and urine culture specimens were obtained prior to the initiation of antibiotic therapy.Patients in Group 1 were treated with oral therapy using ofloxacin 400 mg q12h plus clindamycin 900 mg q8h until 24 hrs of afebrility. In Group 2, patients were treated with clindamycin 900 mg IV q8h plus gentamicin IV 5mg/kg/d q 8h until afebrility. Antibiotic therapy was continued for at least 48 hours unless significant clinical deterioration occurred necessitating the withdrawal of the patient from the study.Results:Conclusions: We found in our preliminary study that oral ofloxacin in combination with oral clindamycin was equally as efficacious, well tolerated, and safe as the combination of intravenous therapy with clindamycin and gentamicin for the treatment of postpartum endomyometritis.
Pietrantoni
M
University of Louisville, Department of Maternal-Fetal Medicine, USA
Goss
S
Gall
SA