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.