Savaris 2007

Methods	Randomized controlled trial.
Participants	Inclusion criteria: history of pelvic discomfort for < 30 days, with findings of pelvic organ tenderness (uterine or adnexal) on bimanual examination, and leukorrhoea or mucopurulent cervicitis. Exclusion criteria: current urinary infection; pregnancy; presence of tubo‐ovarian abscess, endometriosis, appendicitis, diverticulitis, haemorrhagic ovarian cysts or torsion; abdominal hernia; homelessness; fever > 38 °C; abdominal rebound tenderness; pelvic pain > 30 days' duration; allergy to ceftriaxone, azithromycin, or doxycycline; history of antimicrobial therapy within 7 days of recruitment; delivery, abortion, or gynaecological surgery within 30 days; prior hysterectomy or bilateral salpingectomy; and oral intolerance for the antibiotics. Number of women randomized: 133. Number of women analyzed: group A: 66; group B: 67. Number of withdrawals/exclusions/loss to follow‐up and reasons: group A: 4 lost to follow‐up, 2 discontinued intervention (1 oral intolerance, 1 worsening of the pain); group B: 7 lost to follow‐up: 9 discontinued intervention (2 oral intolerance, 7 worsening of pain). Number of centres: 1. Age (mean ± SD) (years): group A: 28.3 ± 0.8; group B: 29.27 ± 1.1. Country: Brazil.
Interventions	Group A: ceftriaxone IM 250 mg + azithromycin 1 g PO single dose and repeated after 7 days. Group B: ceftriaxone IM 250 mg + doxycycline 200 mg PO for 14 days.
Outcomes	Primary outcome: clinical cure defined as ≥ 70% reduction in the total tenderness score at day 14 compared with baseline, for both visual analogue scale and McCormack pain scale. Secondary outcome: microbial cure of C trachomatis.
Notes	Ethical approval: study protocol approved by ethics committee of Hospital de Clínicas de Porto Alegre, and registered at isrctn.org under ISRCTN46117662. Informed consent: enrolled in study after signing the informed consent. Source of funding: supported by Grupo de Pesquisa e Pos‐Graduacão Do Hospital de Clínicas de Porto Alegre under grant # 03/006. GenProbe (San Diego, CA) donated the kits to run the bacteriological analysis, and Pfizer (New York, NY) donated azithromycin to the Global Program to Eliminate Trachoma (Dr Schachter had a National Institutes of Health grant to do operational research on azithromycin treatment of trachoma, and the company donated the drug). The drug used in this study was obtained independently in Brazil, without Pfizer support. The other authors had no potential conflicts of interest to disclose.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Used computer‐generated table for allocation sequence. Women allocated in blocks of 4.
Allocation concealment (selection bias)	Low risk	To avoid bias, both medications were manipulated by the hospital pharmacy and put in identically coded blisters and capsules. Because of the difference in the number of capsules in each treatment, the empty azithromycin blisters were filled with placebo.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Women and assessors blinded to group assignment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Women and assessors blinded to group assignment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low attrition rate (< 20%).
Selective reporting (reporting bias)	Low risk	Trial protocol published (ISRCTN46117662).
Other bias	Unclear risk	The drug used in this study was obtained independently in Brazil, without Pfizer support. Analysis was provided as modified ITT, where conditions others than PID were excluded from analysis after randomization.