Pelvic Inflammatory Disease (PID) MedDRA version: 14.1 Level: PT Classification code 10034254 Term: Pelvic inflammatory disease System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Azithromycin
Pharmaceutical Form: Tablet
INN or Proposed INN: Azithromycin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name: Ofloxa
Sponsors
Brighton and Sussex University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Presence of all of: a)Pelvic discomfort for =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: a) Women who do not consent b) Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: To compare the incidence of side effects in each group (tolerability) To compare the adherence between the two groups To estimate the prevalence of causative organisms (gonorrhoea, chlamydia, mycoplasma) in the study population; To assess microbiological cure where an organism is identified; To identify mycoplasma anti-microbial resistance if present; To compare the relative costs of the two regimens ;Primary end point(s): Our primary outcome captures clinical efficacy at day 14-21 (>70% reduction in tenderness score from baseline). | — |
Countries
United Kingdom
Outcome results
None listed