Landers 1991

Methods	Randomized controlled trial.
Participants	Inclusion criteria: women with either laparoscopically confirmed salpingitis or histologically confirmed plasma cell endometritis or they met previously published criteria for non‐invasive diagnosis of salpingitis. Criteria included direct abdominal tenderness, cervical motion tenderness, and adnexal tenderness, plus ≥ 1 of the following: temperature ≥ 38 °C, peripheral blood leukocytosis WBC > 10,500/mm3, purulent material or culdocentesis, evidence of pelvic abscess on ultrasonography or pelvic examination, evidence of gonococcal or chlamydial cervicitis (by positive monoclonal antibody test or by Gram's stain showing gram‐negative intracellular diplococcic), or mucopurulent cervicitis as previously defined. Exclusion criteria: allergy to any of the 4 antibiotics involved in trial; pregnancy; or history of pelvic surgery, abortion, uterine curettage, or delivery within 6 weeks of admission. Number of women randomized: 162. Number of women analyzed: 148, group A: 75; group B: 73. Number of withdrawals/exclusions/loss to follow‐up and reasons: 14; reasons for exclusion: incorrect diagnosis that was discovered at laparoscopy or laparotomy, refusal of the woman to remain hospitalized long enough to complete treatment. Number of centres: 2. Age (mean ± SD) (years): total: 23.5 ± 6.1; group A: 23.3 ± 5.3; group B: 23.8 ± 6.0. Country: US.
Interventions	Group A: cefoxitin 2 g IV every 6 h + doxycycline 100 mg IV every 12 h for minimum 4 days and at least 48 h after disappearance of fever. Women without fever on admission treated for minimum of 4 days in the hospital for at least 24 h beyond the adequate relief of pain and tenderness to a normal lifestyle without surgical intervention. After discharge from the hospital, doxycycline 100 mg PO twice daily was continued to complete a total of 14 days of treatment. Group B: clindamycin 600 mg IV every 6 h + tobramycin 2 mg/kg IV for 1 dose, followed by 1.5 mg/kg IV every 8 h for minimum of 4 days and for at least 48 h after disappearance of fever. Women without fever on admission treated for minimum of 4 days in hospital for at least 24 h beyond adequate relief of pain and tenderness to a normal lifestyle without surgical intervention. After discharge from hospital, clindamycin 450 mg PO 4 times daily continued to complete a total of 14 days of treatment.
Outcomes	Primary outcome (ITT): clinical response for a satisfactory initial clinical response defined as an improvement of admitting signs and symptoms, included abdominal‐pelvic pain, fever, and pelvic tenderness. Follow‐up evaluation performed at hospital discharge and at 2‐6 weeks after initial enrolment. Secondary outcomes (PP): microbiological clearance of C trachomatis and reduction in tenderness score.
Notes	Ethical approval: yes, study reviewed and approved by institutional review board at both hospitals. Informed consent: yes, written informed consent obtained from all women before enrolment. Source of funding: supported in part by National Institutes of Health grants AI12192 and 1PO1 AI24768 and by Merck, Sharp & Dohme, Westpoint, PA. 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	Non‐blinded study.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Non‐blinded study.
Incomplete outcome data (attrition bias) All outcomes	Low risk	100% follow‐up.
Selective reporting (reporting bias)	Unclear risk	No study protocol found.
Other bias	Unclear risk	Not stated.