Comparison of the equivalence of ceftriane plus azithromycin or doxycycline for the treatment of pelvic inflammatory disease

INTERVENTION: Eligible patients were invited to participate in the doxycycline azithromycin protocol (DAZ). After giving written consent, a standardized interview, examination and specimen collection techniques were taken. Only three researchers will perform the physical exams. Whenever possible, the researcher that performed the first clinical examination on the first visit also did follow up on that patient. A standardized screening examination, including a visual pain scale (0‐10), and the McCormick modified pain scale was performed in the same sequence by the three researchers. A complete blood count, endometrial biopsy, urinalysis, and erythrocyte sedimentation rate will be performed on the first visit. Endometrial samples will be divided into two equal amounts. One will be snap frozen in liquid nitrogen for Polymerase Chain Reaction (PCR) analysis and the other will be fixed in formaldehyde for histological analysis. After the initial interview, the patient will receive a parenteral 250 mg ceftriaxone injection and will be randomly allocated to one of two treatment groups. Randomization and treatment: A restricted randomization sequence list was generated by computer, and was kept concealed from the researcher until the moment of assignment. We will consider subjects in blocks of four at a time to create the allocation sequence. After the patient is enrolled in the protocol, she will be blindly assigned to a coded treatment, either 14 days doxycycline or 1 g of azithromycin per week for two weeks. To avoid bias, the medication will be manipulated by the hospital pharmacy and will be put in identically coded blisters (treatment A, treatment B). To confirm compliance, a treatment of just seven days will be given to the patient, forcing her to return in seven days to receive the rest of the treatment. Because of the difference in the amount of capsules in each treatment, the azithromycin blister was filled up with placebo. In the first visit, the patient will receive 250 mg i CONDITION: Pelvic inflammatory disease ; Urological and Genital Diseases ; Pelvic inflammatory disease PRIMARY OUTCOME: The primary outcome for the trial is clinical cure, defined as improvement or absence of the initial pain at day 14 compared to baseline. SECONDARY OUTCOME: 1. A clinical cure, defined as 70% or greater reduction in the total tenderness score at day 14 compared to baseline; 2. Histological cure defined as absence of plasma cell per X120 field in the endometrial stroma and <5 neutrophils per X400 field in the endometrial surface; 3. Absence of Neisseria gonorrhea and Chlamydia trachomatis on endometrial samples on day 30 by PCR techniques INCLUSION CRITERIA: 1. A history of pelvic discomfort for a period of 30 days or less 2. Findings of pelvic organ tenderness (uterine or adnexal) on bimanual examination 3. Leukorrhea and/or mucopurulent cervicitis and/or untreated known positive gonococcal or chlamydial cervicitis