Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: Results of a multicentre, randomised controlled trial

Gillian Dean*, Suneeta Soni, Rachel Pitt, Jonathan Ross, Caroline Sabin, Jennifer Whetham

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

Objective: A multicentre, randomised non-inferiority trial compared the efficacy and safety of 14 days of ofloxacin and metronidazole (standard-of-care (SoC)) versus a single dose of intramuscular ceftriaxone followed by 5 days of azithromycin and metronidazole (intervention arm (IA)) in women with mild-to-moderate pelvic inflammatory disease (PID). 

Methods: Women with a clinical diagnosis of PID presenting at sexual health services were randomised to the SoC or IA arms. Treating clinicians and participants were not blinded to treatment allocation but the clinician performing the assessment of primary outcome was blinded. The primary outcome was clinical cure defined as ≥70% reduction in the modified McCormack pain score at day 14-21 after starting treatment. Secondary outcomes included adherence, tolerability and microbiological cure. Results Of the randomised population 72/153 (47.1%) reached the primary end point in the SoC arm, compared with 68/160 (42.5%) in the IA (difference in cure 4.6% (95% CI -15.6% to 6.5%). Following exclusion of 86 women who were lost to follow-up, attended outside the day 14-21 follow-up period, or withdrew consent, 72/107 (67.3%) had clinical cure in the SoC arm compared with 68/120 (56.7%) in the IA, giving a difference in cure rate of 10.6% (95% CI -23.2% to 1.9%). We were unable to demonstrate non-inferiority of the IA compared with SoC arm. Women in the IA took more treatment doses compared with the SoC group (113/124 (91%) vs 75/117 (64%), p=0.0001), but were more likely to experience diarrhoea (61% vs 24%, p<0.0001). Of 288 samples available for analysis, Mycoplasma genitalium was identified in 10% (28/288), 58% (11/19) of which had baseline antimicrobial resistance-associated mutations. 

Conclusion: A short-course azithromycin-based regimen is likely to be less effective than the standard treatment with ofloxacin plus metronidazole. The high rate of baseline antimicrobial resistance supports resistance testing in those with M. genitalium infection to guide appropriate therapy. 

Original languageEnglish
Pages (from-to)177-182
Number of pages6
JournalSexually Transmitted Infections
Volume97
Issue number3
DOIs
Publication statusPublished - 1 May 2021

Bibliographical note

Funding Information:
Disclaimer This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0609–19279). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Funding Information:
Funding Funding for this trial was provided by the NIHR Research for Patient Benefit programme (award reference number PB-PG-0609–19279).

Publisher Copyright:
©

Keywords

  • azithromycin
  • mycoplasma
  • pelvic inflammatory disease

Fingerprint

Dive into the research topics of 'Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: Results of a multicentre, randomised controlled trial'. Together they form a unique fingerprint.

Cite this