Maria 1992

Methods	Randomized controlled trial.
Participants	Inclusion criteria: women aged 15‐51 years who required hospitalization for treatment of acute PID based on clinical and laboratory evidence. All women had abdominal, parametrial, and cervical motion tenderness. The additional finding of fever, leukocytosis, pelvic mass, or purulent material in the peritoneal cavity confirmed the diagnosis. Exclusion criteria: allergies to study drugs, requirement for concomitant therapy with other antibiotics, and > 2 doses of antibiotics in the 7 days prior to admission. Number of women randomized: 170 women; group A: 88; group B: 82. Number of women analyzed: 170 women; group A: 88; group B: 82. Number of withdrawals/exclusions/loss to follow‐up and reasons: group A: 28; group B: 27 due to failure to follow randomization scheme, protocol deviation, and incorrect diagnoses. Number of centres: 10. Age (mean) (years): whole study group: 28; age per group not stated. Country: 9 in Europe and 1 Africa.
Interventions	Group A: clindamycin 900 mg IV every 8 h + gentamicin 2 mg/kg IV, followed by 1.5 mg/kg IV every 8 h for minimum of 4 days. At the end of the period of IV therapy, clindamycin 450 mg PO every 6 h was given to complete 14 days of treatment. Group B: cefoxitin 2 g IV every 6 h + doxycycline 100 mg IV every 12 h were given for at least 4 days. At the end of IV therapy, doxycycline 100 mg PO was given every 12 h to complete a total of 14 days of treatment.
Outcomes	Primary outcomes: clinical failure, minimum of 48 h of protocol therapy and characterized by signs and symptoms as unchanged or worsened during the first 48‐72 h of treatment, or worsening later, failure to improve further; need of additional antibiotics or need for surgery considered as failure; adverse events leading to discontinuation of therapy. Secondary outcomes: microbial cure of C trachomatis and N gonorrhoeae.
Notes	Ethical approval: not stated. Informed consent: yes, informed consent obtained from all women prior to entry into the trial. 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	Not stated how randomization sequence was generated.
Allocation concealment (selection bias)	Unclear risk	Not stated by whom allocation concealment was done.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label study.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study.
Incomplete outcome data (attrition bias) All outcomes	High risk	115/170 women analyzed (68%).
Selective reporting (reporting bias)	Unclear risk	No study protocol found.
Other bias	Unclear risk	Not stated.