Background/introduction Crucial to treatment success in PID is adherence to therapy. All guidelines recommend 14-days of therapy although many women fail to complete 2-weeks, particularly if they experience side-effects. A shorter course of antibiotics may offer a valuable treatment alternative.
Aim(s)/objectives To compare clinical efficacy/acceptability of standard PID treatment 14-days with 5-day course of antibiotics for mild-moderate PID (pain for <30 days).
Methods A multicentre, open-label, non-inferiority RCT comparing arm-1 (ofloxacin/metronidazole) with arm-2 (azithromycin 1g day-1; 500mg od day-2–5, metronidazole/ceftriaxone). Efficacy was measured using standard pain-scores at baseline and 14–21 day follow-up looking for a 70% reduction; women who failed to complete treatment/return for follow-up were considered treatment failures.
Results N = 313 (152 arm-1, 162 arm-2 with similar baseline characteristics). Median age 25. Lower abdo-pain 95%, discharge 64%, dyspareunia 53%. Baseline pain-score median 8/36 (range 1–26); day 14–21 0/36 (range 0–18). Considering women who failed to complete therapy/return for follow-up as failures, the proportion with 70% pain reduction was 46.7% for arm-1; 42.2% for arm-2 (p = 0.49, difference in proportions (arm-2 minus arm-1) −4.5% (95% CI −15.5%, 6.5%)). For those women completing therapy the proportion with a 70% pain reduction was 68.9% for arm-1; 57.6% for arm-2 (p = 0.11, difference in proportions −11.3% (95% CI −23.9%, −1.3%). There were no significant differences in reported side effects except diarrhoea: 33.6% arm-1 vs 78.1% arm-2 (p = 0.0001).
Discussion/conclusion In terms of pain reduction we could not demonstrate that the shorter azithromycin course was non-inferior to the standard-of-care. Patients also experienced significantly more diarrhoea. This study highlights the importance of using evidence-based treatment regimens.