Condition category
Urological and Genital Diseases
Date applied
25/02/2014
Date assigned
25/02/2014
Last edited
28/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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), will be invited to participate in the study.

What does the study involve?
Women will be examined, will have swabs taken to check for infection and will be asked to fill in a questionnaire about pain and their beliefs around medicines. Women will then be randomly allocated to either the standard of care (14 days of antibiotics) or the 5-day course of antibiotics. The women and research nurse will know which antibiotics they are taking, but not the doctor. At follow-up in the clinic women will be asked to complete a further questionnaire about pain, health beliefs, side effects and ability to take the tablets. The research nurse will call the women at 68 weeks for a final assessment, and where infection was found, invite women for repeat samples.

What are the possible benefits and risks of participating?
If we find a difference 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 to your health from any of the antibiotics; they are all used commonly for other conditions. All antibiotics can sometimes cause nausea, vomiting and rash but you 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?
The study started in November 2012 and is running until May 2015..

Who is funding the study?
National Institute for Health Research, UK.

Who is the main contact?
Dr Gillian Dean, Chief Investigator (gillian.dean@bsuh.nhs.uk)
Trial Co-ordinators Gemma Earl and Marie Hyslop

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gillian Dean

ORCID ID

Contact details

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
gillian.dean@bsuh.nhs.uk

Additional identifiers

EudraCT number

2011-023254-36

ClinicalTrials.gov number

Protocol/serial number

11656

Study information

Scientific title

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

Acronym

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.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11656

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Infection, Reproductive Health and Childb; Subtopic: Infection (all Subtopics), Reproductive Health and Childb (all Subtopics); Disease: Infectious diseases and microbiology , Reproductive Health & Childbirth

Intervention

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

Drug

Phase

Phase IV

Drug names

Azithromycin

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

02/11/2012

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Female

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

02/11/2012

Recruitment end date

01/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Sussex County Hospital
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Brighton and Sussex University Hospitals NHS Trust (UK)

Sponsor details

Mr Scott Harfield
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
scott.harfield@bsuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes