Pelvic inflammatory disease Urological and Genital Diseases Pelvic inflammatory disease
Conditions
Interventions
Eligible patients were invited to participate in the doxycycline azithromycin protocol (DAZ). After giving written consent, a standardized interview, examination and specimen collection techniques wer
Sponsors
Foundation for the Incentive of Research (Fundacao de Incentivo a Pesquisa) (FIPE) (Brazil)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Current pregnancy as demonstrated by beta-Human Chorionic Gonadotrophin (HCG) or ultrasonography 2. Inability to tolerate an outpatient oral regimen as demonstrated by the vomiting of eight ounces of water one hour after taking 10 mg of metoclopramide 3. Presence of tubo-ovarian abscess, appendicitis or hemorrhagic ovarian cysts confirmed by ultrasound or laparoscopy 4. Pelvic pain over 30 days duration 5. Allergy to ceftriaxone, azithromycin or doxycycline 6. Antimicrobial therapy within seven days of recruitment 7. Delivery, abortion or gynecological surgery within 30 days 8. Prior hysterectomy or bilateral salpingectomy 9. Homelessness 10. Fever 11. Abdominal rebound tenderness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Outcome results
None listed