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. 2017 Apr 24;2017(4):CD010285. doi: 10.1002/14651858.CD010285.pub2
Methods Randomized controlled trial.
Participants Inclusion criteria: women with PID diagnosis based on all the following criteria: pelvic pain, either spontaneous or at palpation; cervical motion tenderness; and adnexal pain.
Exclusion criteria: aged < 16 year, current pregnancy, allergy to 1 of the medications used in study or to penicillin, serum creatinine > 1.5 mg/dL, previous or current hepatic disease, use of antibiotics in the last 7 days, in situ IUD.
Number of women randomized: 78.
Number of women analyzed: 76; group A: 40; group B: 36.
Number of withdrawals/exclusions/loss to follow‐up and reasons: 2, intolerance to penicillin.
Number of centres: 1.
Age (mean ± SD) (years): group A: 25.3 ± 7.7.4; group B: 29.4 ± 7.8.
Country: Italy.
Interventions Group A: gentamicin, 2 mg/kg IV (attack dose), followed by 1.5 mg/kg IV every 8 h + clindamycin 900 mg IV every 8 h for 4 days, followed by clindamycin 450 mg PO every 6 h for a total of 14 days of treatment.
Group B: ceftazidime 1 g IV every 8 h + doxycycline 100 mg PO every 12 h for 4 days, followed by doxycycline 100 mg PO every 12 h for a total of 14 days of treatment.
Outcomes Primary outcome: clinical recovery, defined as: body temperature < 37 °C per 48 h, disappearance of pelvic pain, no increase of eventual adnexal mass after 7 days of the end of treatment.
Secondary outcome: follow‐up performed 30 days after treatment finished; endocervical culture for N gonorrhoeae and C trachomatis and endometrial culture for C Trachomatis performed in all positive cases at admission.
Notes Ethical approval: not stated.
Informed consent: not stated.
Funding source: no funding stated or declaration of interest.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Women were randomly allocated into 2 treatment groups.
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 2/78 women excluded from analysis.
Selective reporting (reporting bias) Unclear risk Not stated.
Other bias Unclear risk Not stated.