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Azithromycin for the treatment of pelvic inflammatory disease (PID)

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51790058
Enrollment
396
Registered
2014-02-25
Start date
2011-11-01
Completion date
Unknown
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Infection, Reproductive Health and Childb

Interventions

Standard of care (14 days of antibiotics) or the 5 day course of antibiotics. Abdominal & Bimanual Exam, Modified McCormack Score used. Baseline and Day 14-21
BMQ questionnaire Baseline and Day 14-21
Informed Consent, Informed consent in writing before any protocol specific procedures MARS Questionnaire, Day 14-21 visit Side Effects Questionnaire, Day 14-21 visit

Sponsors

Brighton and Sussex University Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria: 1. Women who do not consent 2. Age 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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026