Azithromycin for the treatment of PID

• Research type

  Research Study

• Full title

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

• IRAS ID

  65080

• Contact name

  Gillian Dean

• Sponsor organisation

  Brighton and Sussex University Hospitals

• Eudract number

  2010-023254-36

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  PID is caused by the spread of sexually transmitted infections from the vagina & 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, & antibiotics cause significant side effects, many women stop taking the medication early, with potential persistence of the infection & further complications . 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, & whether women find the shorter course more acceptable when compared to the current standard of treatment. Women who attend genitourinary clinic, their GP or a gynaecologist in Brighton or Sheffield with mild to moderate symptoms of PID will be invited to participate in the study. Women will be examined, have swabs taken to check for infection and asked to fill in a questionnaire about pain and their beliefs around medicines. Women will then be randomised (like flipping a coin) to either the standard of care (14 days of antibiotics) or the 5 day course of antibiotics. The women & 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 6-8 weeks for a final assessment, and where infection was found, invite women for repeat samples. Finally an economic comparison between the two antibiotic approaches will be performed.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  10/H1107/70

• Date of REC Opinion

  10 Mar 2011

• REC opinion

  Further Information Favourable Opinion