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

Completed

Conditions: Pelvic inflammatory disease
Urological and Genital Diseases

Registration Number: ISRCTN46117662

Lead Sponsor: Foundation for the Incentive of Research (Fundacao de Incentivo a Pesquisa) (FIPE) (Brazil)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 112

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1. A clinical cure, defined as 70% or greater reduction in the total tenderness score at day 14 compared to baseline<br>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<br>3. Absence of Neisseria gonorrhea and Chlamydia trachomatis on endometrial samples on day 30 by PCR techniques