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. 2017 Apr 24;2017(4):CD010285. doi: 10.1002/14651858.CD010285.pub2
Methods Randomized controlled trial.
Participants Inclusion criteria: non‐pregnant, non‐lactating women using a reliable form of contraception who met the inclusion criteria for acute salpingitis.
Exclusion criteria: pelvic infection severe enough to require parenteral antimicrobial therapy (diffuse peritonitis) or if surgical intervention within the next 24 h was anticipated; evidence of a pelvic abscess on sonographic or clinical examination.
Number of women randomized: 96; unclear how many to each group.
Number of women analyzed: group A: 35; group B: 37. PP analysis only.
Number of withdrawals/exclusions/loss to follow‐up and reasons: 24 women considered unevaluable because of total non‐compliance with study drug (1 woman) or lack of attendance at any follow‐up visits (23 women).
Number of centres: 1.
Age (mean) (years): total age not stated; group A: 24.7; group B: 23.3.
Country: US.
Interventions Group A: cefoxitin 2 g IM + probenecid 1 g PO followed by doxycycline 100 mg PO every 12 h for 10 days.
Group B: ofloxacin 400 mg PO every 12 h for 10 days.
Outcomes Primary outcomes: clinical cure defined as complete resolution of tenderness (> 65% decrease in clinical score); adverse events leading to discontinuation of therapy.
Secondary outcomes: microbiological clearance of chlamydia; microbiological clearance of gonorrhoea.
Notes Ethical approval: unclear. Study approved by Texas Southwestern Medical Center Institutional Review Board.
Informed consent: women enrolled after they gave informed consent.
Source of funding: supported in part by a grant from Ortho Pharmaceutical Corporation, Raritan, NJ. No conflicts of interest reported.
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 High risk Open‐label.
Blinding of outcome assessment (detection bias) All outcomes High risk Open‐label.
Incomplete outcome data (attrition bias) All outcomes High risk 24/96 women considered unevaluable.
Selective reporting (reporting bias) Unclear risk No study protocol found.
Other bias Unclear risk Not stated.

CDC: Centers for Disease Control and Prevention; ESR: erythrocyte sedimentation rate; h: hour; IM: intramuscular; ITT: intention to treat; IV: intravenous; n: number of women; PID: pelvic inflammatory disease; PO: per os; PP: per protocol; SD: standard deviation; IUD: intrauterine device.