Title: Is a short course of azithromycin effective in the treatment of mild to moderate pelvic inflammatory disease?
Funder: Department of Health (England)

Abstract: Background Pelvic inflammatory disease (PID) is a sexually transmitted infection (STI) commonly diagnosed in women of childbearing age. Infertility, ectopic pregnancy and chronic pelvic pain occur in up to 1 in 5 individuals and are more likely if treatment is delayed or taken incorrectly. Currently recommended antibiotic regimens, all given over 14 days, have cure rates of 90-97% but only if taken in full. Recent studies show the importance of the STI Mycoplasma genitalium (MG) in PID, which is not adequately treated by current regimens. Expert opinion and small studies support the use of azithromycin-based therapy for PID, which are effective against MG. However further evidence is needed to confirm clinical efficacy and to assess tolerability when given as part of a 5-day antibiotic regimen. Aims The overall aim of this multidisciplinary study is to assess the clinical efficacy and acceptability of a 5-day course of antibiotics compared with the standard 14-day course in the treatment of mild-moderate pelvic inflammatory disease (PID). The primary objective is to assess clinical efficacy of the treatment regimen at day 14-21 by comparing improvement in pain scores. The secondary objectives are: • To compare the incidence of side effects in each group (tolerability) • To compare the proportion of treatment taken by women • To estimate of MG prevalence in the study population • To assess microbiological cure in women where an organism is identified • To compare the relative costs of the two regimens • To assess long term reproductive and clinical outcomes in each group Plan of Investigation Women diagnosed with mild-moderate PID, attending Genito-Urinary Medicine (GUM) clinics in Brighton and Sheffield will be invited to take part in this study. Local gynaecologists and GP practices will refer eligible women to study nurses based in GUM. Consenting women will be randomised to receive either the standard 14-day treatment (doxycycline and metronidazole with one intramuscular injection of ceftriaxone or ofloxacin and metronidazole) or a shorter 5-day course of azithromycin and metronidazole with one injection of ceftriaxone. Clinical cure will be assessed at 14-21 days using modified McCormack scores and visual analogue scales for pain. Side effects, adherence, microbiological outcomes, relative costs and long term clinical outcomes will be compared between the two arms Potential Impact This study has the potential to influence treatment of PID across Primary Care, GUM and Gynaecology, locally and nationally. In the short term, we expect this 5-day regimen to offer efficacious treatment for PID with a better treatment experience for women. A better-tolerated, shorter treatment regimen means prompt resolution of symptoms and fewer side effects for women, particularly those with difficulty taking 14 days of antibiotics (e.g. younger women). In the medium term this will reduce the number of follow-up appointments needed across the specialities. In the longer term women would be less likely to develop serious complications, with reduced cost implications for the NHS.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;INFECTION