Is a short course of azithromycin effective in the treatment of mild to moderate pelvic inflammatory disease (PID)? - Azithromycin for the treatment of PID

Conditions: Pelvic Inflammatory Disease (PID)
MedDRA version: 14.1Level: PTClassification code 10034254Term: Pelvic inflammatory diseaseSystem Organ Class: 10021881 - Infections and infestations

Registration Number: EUCTR2010-023254-36-GB

Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Presence of all of:
a)Pelvic discomfort for < 30 days
b)*Adnexal tenderness on bimanual pelvic examination +/- cervical motion tenderness*

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

a)Women who do not consent
b)Age < 16 years
c)Abdominal pain requiring hospital admission
d) Positive pregnancy test or *breast feeding*
f)Urinary tract infection
g)Temperature >380C requiring inpatient care
h)Antibiotics within the last 7 days
i) Presence of intracellular gram negative diplococci on baseline microscopy
j) Sexual contact of gonorrhoea infection (last 3 months)
k)Known allergy or intolerance to antibiotic component
l)Ultrasound scan showing other pathology
m) History of epilepsy
n) Severe depression

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess clinical efficacy of the treatment regimens at day 14-21 by comparing improvement in pain scores.;Secondary Objective: The secondary objectives are:<br>To compare the incidence of side effects in each group (tolerability)<br>To compare the adherence between the two groups <br>To estimate the prevalence of causative organisms (gonorrhoea, chlamydia, mycoplasma) in the study population; <br>To assess microbiological cure where an organism is identified; <br>To identify mycoplasma anti-microbial resistance if present;<br>To compare the relative costs of the two regimens<br>;Primary end point(s): Our primary outcome captures clinical efficacy at day 14-21 (>70% reduction in tenderness score from baseline).

Secondary Outcome Measures