Roy 1990

Methods	Randomized controlled trial.
Participants	Inclusion criteria: lower abdominal pain and tenderness, cervical motion or adnexal tenderness, and 1 of the following: oral temperature > 38 °C, leukocytosis > 10,500/mm3, or presence of a suspected inflammatory pelvic mass on examination or by ultrasound. Exclusion criteria: allergy to cephalosporins or penicillins; had taken antibiotics in the previous 3 days; had received any investigational drugs in the previous 30 days; pregnant or breastfeeding; rapidly progressive underlying disease that could preclude evaluation of therapy; or required other systemic antibiotics on admission. Number of women randomized: 67. Number of women analyzed: total: 67; group A: 13; group B: 14; group C: 19; group D: 21. Number of withdrawals/exclusions/loss to follow‐up and reasons: 3 women, 1 because of protocol violation and 2 left the study before completion of therapy. Number of centres: 1. Age (mean ± SEM) (years): group A: 26.6 ± 1.9; group B: 28.9 ± 1.7; group C: 27.1 ± 1.3; group D: 28.3 ± 1.0. Country: US.
Interventions	Group A: ceftizoxime 2 g IV every 12 h + doxycycline 100 mg IV twice daily. Group B: ceftizoxime 2 g IV every 6 h + doxycycline 100 mg IV twice daily. Group C: ceftizoxime 2 g IV every 8 h + doxycycline 100 mg IV twice daily. Group D: clindamycin 900 mg IV every 8 h + gentamicin 2 mg/kg loading dose followed by 1.5 mg/kg IV every 8 h with adjustments if necessary.
Outcomes	Primary outcomes: clinical cure: adequate response to therapy: clinically improved and afebrile for 48 h at the time of discharge; 8‐24 before discharge; no pelvic tenderness; adverse events leading to discontinuation of therapy. Secondary outcomes: microbial cure of C trachomatis, microbial cure of N gonorrhoeae, and length of hospital stay.
Notes	Ethical approval: not stated. Informed consent: yes, women signed informed consent forms previously approved by institutional review board. Source of funding: financial assistance, in part, provided by Smith Kline & French Laboratories, Philadelphia, PA. No conflicts of interest reported. Follow‐up: 10‐14 days.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated.
Allocation concealment (selection bias)	Unclear risk	Not stated.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated.
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 women withdrew from the study or were lost to follow‐up.
Selective reporting (reporting bias)	Unclear risk	No study protocol found.
Other bias	Unclear risk	Not stated.