| Methods | Randomized, double‐blind, comparative study. | |
| Participants |
Inclusion criteria: women aged 18‐55 years with clinical diagnosis of mild or moderate PID, as confirmed by laparoscopy graded according to the methods of Hager and colleagues (Hager 1983); and Soper (Soper 1991). Exclusion criteria: observable pelvic mass; presented with laparoscopic evidence of severe PID; pregnant or breastfeeding; allergic to clindamycin, ciprofloxacin, ceftriaxone, or doxycycline; required other antibiotic therapy for non‐protocol reasons; had had pelvic or abdominal surgery in the 30 days prior to admission (except emergency exploratory laparoscopy resulting in a primary diagnosis of PID that did not require pelvic cleanup); had concomitant disease that could have affected the evaluation of response to protocol therapy (such as inflammatory bowel disease or significant renal or hepatic disease); had a history of colitis; were known to have frequent sexual contacts with multiple partners; were seropositive for syphilis; had severe medical condition(s) (e.g. neoplasms or haematological malignancy); had taken ≥ 2 antibiotics within 72 h before evaluation for enrolment in the study; had received any investigational drug 30 days before evaluation for enrolment; or had been previously enrolled in the study. Number of women randomized: 69 in each group. Number of women analyzed: .69 in each group Number of withdrawals/exclusions/loss to follow‐up and reasons: 2 in the clindamycin+ciprofloxacin group; 1 chose to discontinue because she was asymptomatic and 1 withdrew because of a side effect. In the ceftriaxone+doxycycline group, 1 withdrew because of a side effect, 1 was lost to follow‐up and 1 was withdrawn because of receiving additional antibiotic treatment for syphilis after initiation of study medication. Number of centres: 6; Chile (1 centre), Peru (2 centres), Colombia (2 centres), and Mexico (1 centre). Age (mean) (years): group A: 28.9; group B: 30.7. Country: Mexico |
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| Interventions |
Group A: clindamycin 300 mg (2 capsules 3 times daily) + ciprofloxacin (250 mg, 1 tablet twice daily) for 14 days and placebo IM (for an equivalent of 1 dose of ceftriaxone). Group B: ceftriaxone 250 mg IM (as a single dose) + doxycycline 100 mg (1 capsule twice daily) and placebo (2 capsules 3 times daily for equivalent doses of clindamycin) for 14 days. |
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| Outcomes | Clinical cure defined by the absence of, or minimal, pelvic tenderness, temperature < 37.5 °C, and a WBC count of 10,000/mm3, if a minimum of 4 days of treatment had been completed. Clinical improvement defined as resolution of 2 of these 3 symptoms. Failure when 1 of the following circumstances was noted after at least 48 h of protocol therapy: signs and symptoms remained unchanged or worsened (during the first 72 h of therapy). Microbiological cure defined as eradication of N gonorrhoeae or C trachomatis (or both) from clinically cured women. Failure defined as persistence of 1 or both of these 2 organisms or, in the case of clinical improvement or failure, the presence of endocervical pathogens. Superinfection defined as the isolation of ≥ 1 new pathogens. Adverse effects leading to discontinuation of treatment. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | All eligible women randomized to 1 of the treatment groups. |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo medication was added as necessary to complete the double‐blind design. All oral medication was encapsulated to ensure blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo medication was added as necessary to complete the double‐blind design. All oral medication was encapsulated to ensure blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated. |
| Selective reporting (reporting bias) | Unclear risk | No trial protocol found. |
| Other bias | Unclear risk | Not stated. |