Azithromycin for the treatment of pelvic inflammatory disease (PID)

Phase 4

Completed

• Conditions: Urological and Genital Diseases; Inflammatory diseases of female pelvic organs; Topic: Infection, Reproductive Health and Childb; Subtopic: Infection (all Subtopics), Reproductive Health and Childb (all Subtopics); Disease: Infectious diseases and microbiology , Reproductive Health & Childbirth

• Registration Number: ISRCTN51790058
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust (UK)

Brief Summary

2020 results in http://dx.doi.org/10.1136/sextrans-2020-054468 (added 06/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Study Completion: 2015-05-01
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 313

Inclusion Criteria

Presence of all of:
1. Pelvic discomfort for < 30 days
2. Direct lower abdominal tenderness +/? rebound tenderness
3. Adnexal/cervical motion tenderness
4. Target Gender: Female; Upper Age Limit 60 years ; Lower Age Limit 16 years

Exclusion Criteria

1. Women who do not consent
2. Age < 16 years
3. Abdominal pain requiring hospital admission
4. Positive pregnancy test
5. Urinary tract infection
6. Temperature >38 °C (indicator of severe infection)
7. Antibiotics within the last 7 days
8. Known allergy or intolerance to antibiotic component
9. Ultrasound scan showing other pathology
10. History of epilepsy
11. Severe depression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical efficacy of treatment regimes; Timepoint(s): Comparing improvement of pain scores: baseline to Day 14-21

Secondary Outcome Measures

Name	Time	Method
<br> 1. Comparison of adherence; Timepoint(s): Day 14-21<br> 2. Comparison of costs; Timepoint(s): 3 month notes review<br> 3. Comparison of side effects; Timepoint(s): Day 14-21<br> 4. Microbiological cure when organisms identified; Timepoint(s): Day 14-21 and 6-8 week follow-up<br> 5. Mycoplasma anti-microbial resistance; Timepoint(s): Day 14-21 and 6-8 week follow-up<br> 6. Prevalence of causative organisms in study population; Timepoint(s): Day 14-21<br>