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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 associated or not associated with endometritis confirmed by laparoscopy according to the clinical criteria described by Hager and colleagues (Hager 1989).
Exclusion criteria: known allergy to betalactamics, pregnant, renal and liver insufficiency.
Number of women randomized: 82.
Number of women analyzed: group A: 42; group B: 40.
Number of withdrawals/exclusions/loss to follow‐up and reasons: 1 abandoned the amoxicillin‐clavulanic acid after knowing that the bacteria (K. pneumoniae) was resistant to the antibiotic. One stopped amoxicillin‐clavulanic acid after 6 days of treatment due to no clinical improvement and she was switched to group B; In group B, one patient stopped the treatment due to side‐effect (Quincke edema)
Number of centres: 8.
Age (mean (range)) (years): group A: 27.7 (18‐46); group B: 28.7 (15‐49).
Country: France.
Interventions Group A: amoxicillin‐clavulanic acid 1 g IV every 8 h for at least 48 h, then 1.5‐2 g PO twice daily. Mean length of treatment 19 days, never less than 14 days.
Group B: amoxicillin 3‐4 g IV per 24 h, mean 4 days, then 1.5‐2 g PO daily. Mean length of treatment 17 days + aminoside (chosen by researcher's preference) 3‐5 mg/kg IM per 24 h 2 or 3 times daily depending of the aminoside, mean length of treatment 7 days + metronidazole 1 or 1.5 g IV or suppository daily.
For each case, a secondary prescription for a tetracycline 200 mg per 24 h was given, either immediately if results of laparoscopy or other investigations justified it, or later on positive chlamydia serology. Length of this treatment 3‐4 weeks as decided by the researcher.
Outcomes Primary outcomes: clinical cure; defined as absence of fever, pain, and previously observed adnexal masses at 5‐8 weeks' follow‐up; adverse events leading to discontinuation of treatment.
Secondary outcome: none reported.
Notes Ethical approval: not stated.
Informed consent: not stated.
Source of funding: not stated, and no conflicts of interest reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The choice of treatment fixed by randomization.
Allocation concealment (selection bias) Unclear risk The choice of treatment fixed by randomization.
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 1/82 women lost to follow‐up.
Selective reporting (reporting bias) Unclear risk No protocol found.
Other bias Unclear risk Not stated.