Plain English Summary
Background and study aims
Pelvic inflammatory disease (PID) is caused by the spread of sexually transmitted infections from the vagina and cervix. If inadequately treated, PID can have serious consequences such as scarring of the fallopian tubes, which can lead to infertility, ectopic pregnancy and chronic pelvic pain. If taken correctly, a standard 14 days of antibiotic treatment has a cure rate of over 90%. However, because symptoms often improve within 7 days and antibiotics cause significant side effects, many women stop taking the medication early, thus the infection may not clear completely and may lead to further complications . The aim of this study is to simplify the standard antibiotic treatment for pelvic inflammatory disease (PID).
Who can participate?
Women who attend the genitourinary clinic with mild to moderate symptoms of PID (pain for less than 30 days)
What does the study involve?
Women are examined, have swabs taken to check for infection and are asked to fill in a questionnaire about pain and their beliefs around medicines. Women are then randomly allocated to either the standard of care (14 days of antibiotics) or the 5-day course of antibiotics. The women and research nurse know which antibiotics they are taking, but not the doctor. At follow-up in the clinic women are asked to complete a further questionnaire about pain, health beliefs, side effects and ability to take the tablets. The research nurse calls the women at 68 weeks for a final assessment, and where infection was found, invites women for repeat samples.
What are the possible benefits and risks of participating?
If a difference is found between the two antibiotic regimens in women with PID it will change the local treatment policies and so may improve future treatments for patients. There are no risks from any of the antibiotics; they are all used commonly for other conditions. All antibiotics can sometimes cause nausea, vomiting and rash but participants may not experience any side effects at all.
Where is the study run from?
This is a multi-centre study running in Brighton, London, Birmingham, Eastbourne/Hastings and Sheffield (UK).
When is the study starting and how long is it expected to run for?
November 2012 to May 2015
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Dr Gillian Dean (Chief Investigator)
2. Gemma Earl and Marie Hyslop (Trial Co-ordinators)
Dr Gillian Dean
Royal Sussex County Hospital
Is a short course of azithromycin effective in the treatment of mild to moderate pelvic inflammatory disease (PID)?
The aim of this study is to assess whether a shorter course of antibiotics taken over 5 days is as effective as the 14 day course and whether women find the shorter course more acceptable when compared to the current standard of treatment.
NRES Committee South East Coast - Brighton and Sussex, 10/03/2011, ref.:10/H1107/70
Randomised; Interventional; Design type: Treatment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Topic: Infection, Reproductive Health and Childb; Subtopic: Infection (all Subtopics), Reproductive Health and Childb (all Subtopics); Disease: Infectious diseases and microbiology , Reproductive Health & Childbirth
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
Telephone follow-up, 6-8 week follow-up visit
Urinalysis, Baseline for pregnancy test
Visual Analogue Scale for Pain, At Baseline and Day 14-21 visit
Follow-Up Length: 2 month(s)
Study Entry: Single Randomisation only
Primary outcome measures
Clinical efficacy of treatment regimes; Timepoint(s): Comparing improvement of pain scores: baseline to Day 14-21
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Participant 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
Target number of participants
Planned Sample Size: 396; UK Sample Size: 396
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Royal Sussex County Hospital
Brighton and Sussex University Hospitals NHS Trust (UK)
Mr Scott Harfield
Royal Sussex County Hospital
National Institute for Health Research (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0609-19279
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
Participant level data
Results - basic reporting