Efficacy and Safety of Ofloxacin in the Treatment of Non- Gonococcal Sexually Transmitted Diseases Ricardo M. Manalastas, M.D., Noel R. Juban, M.D., Noel L. Espallardo, M.D., Guadalupe Natividad-Villanueva, M.D., Arlene Icasiano, M.D., Patricia M. Kho, M.D., Martha Millar-Aquino, M.D, Mary Jane Bonoan, M.D. and Suzette H. Lazo, M.D. ABSTRACT Non-gonococcal infections of the genital tract are usually due to Chlamydia trachomatis. In females, this sexually transmitted pathogen can cause cervicitis and if inadequately treated, can lead to pelvic inflammatory disease, infertility and ectopic pregnancy. The study aimed to determine the efficacy and safety of ofloxacin in the treatment of non- gonococcal STD (chlamydial infections) among Filipino female workers with high-risk behavior. It also aimed to determine the prevalence of chlamydial infection among this group . An uncontrolled open clinical trial was used to determine the efficacy of ofloxacin. Females with high-risk behavior working in massage parlors in the three cities of Quezon, Makati, Pasay were screened for chlamydial infection using the chlamydia optical immunoassay (OIA). Subjects with positive results on the assay were recruited and were given a complete (7-day) course of ofloxacin at 200 mg BID. Repeat chlamydial OIA was done after completion of the antibiotic course. Primary outcome was the cure rate and was defined as the number of subjects with a negative OIA test post-treatment over the total number of treated subjects. Intention-to-treat and per-protocol analysis were used for cure rate and the 95 % Confidence Intervals were computed. Eighty four out of the four hundred and eighty two (482) female workers with high-risk behavior screened tested positive to chlamydia infection giving a prevalence rate of 17.4% (95% CI:14.1% and 21.1%). Thirteen of the 84 were excluded due to pregnancy, mixed infections and refusal to participate in the study and the remaining 71 subjects were given the ofloxacin treatment. Sixty six (66) out of 71 returned for repeat OIA test and all were negative with a per-protocol cure rate of 100.0% (95% CI:94.6% and 100.0%) and an intention-to-treat cure rate of at 93.0% (95% CI: 84.3% and 97.7%). Mild adverse events noted were headache, dizziness, nausea, and vomiting in only 10 patients. In this study, the prevalence of chlamydial infection was 16.8 % among Filipino female workers with high-risk behavior. Ofloxacin given at 200 mg BID for 7 days was efficacious for non-gonococcal (chlamydial) infection among this population with a cure rate of 93.0 %. Minimal adverse events were also noted with the use of ofloxacin. [Phil J Microbiol Infect Dis 2003; 32(3):133-138] Key Words: Chlamydia trachomatis, ofloxacin, female high-risk behavior, sexually transmitted disease INTRODUCTION Chlamydial trachomatis may infect the cervix without any accompanying inflammation at all. 1 Cervical inflammation is surprisingly confusing to diagnose, it being clinically evident or apparent only on colposcopy or histological examination. It is variably associated with recovery of etiological agents. According to Handsfield, 2 the prevalence rate of Chlamydia trachomatis infection among female workers with high-risk behavior is 15-20 %. STD clinics in the US have reported prevalence of 4.5- 32% among patients with mucopurulent cervicitis secondary to chlamydial infection. 1 A local study conducted among female sex workers in Cebu and Manila demonstrated a prevalence rate of 19.7%. 3 Standard therapeutic regimen recommends drugs such as doxycycline and azithromycin for genital chlamydial infection. Though proven to be effective, these cause