Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

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)

Trial website

Contact information



Primary contact

Dr Gillian Dean


Contact details

Royal Sussex County Hospital
Eastern Road
United Kingdom

Additional identifiers

EudraCT number

2011-023254-36 number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

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.

Ethics approval

NRES Committee South East Coast - Brighton and Sussex, 10/03/2011, ref.:10/H1107/70

Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


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

Intervention type



Phase IV

Drug names


Primary outcome measure

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


Reason abandoned (if study stopped)


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

Participant type


Age group




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

United Kingdom

Trial participating centre

Royal Sussex County Hospital
United Kingdom

Sponsor information


Brighton and Sussex University Hospitals NHS Trust (UK)

Sponsor details

Mr Scott Harfield
Royal Sussex County Hospital
Eastern Road
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0609-19279

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

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


Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/08/2020: No publications found. 09/08/2017: Added recruitment dates, publication and dissemination plan, IPD sharing statement.