Intervention 2: ciprofloxacin 500 mg twice daily for 3 days, followed by placebo therapy for the next 4 days (16 participants). Intervention 1: erythromycin 500 mg 4 times daily for 7 days (15 participants). Herpes genitalis was excluded by Tzanck smear from ulcer and donovanosis was ruled out by tissue smear examination stained with giemsa for intracellular bodies. Syphilis was excluded by dark ground illumination and VDRL test. Infection by H ducreyi confirmed through clinical approach supplemented by direct Gram‐stained smear showing Gram‐negative bacilli in a "school of fish" pattern or culture method with confirmatory biochemical test (or both). īaseline characteristics: aetiological diagnosis. Inclusion criteria: participants with confirmed infection by Haemophilus ducreyi.Įxclusion criteria: infection by HIV, donovanosis, syphilis or herpes virus.
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Trial design: single‐centre, parallel, randomized controlled trial, 3 arms. "As treated analyses" and the risk of bias was high according to the level of missing data (> 20%). Cure was objectively assessed and lack of blinding could have affected results. There was no blinding or incomplete blinding, and the outcome or outcome measurement was likely to be influenced by a lack of blinding. "Patients were randomly assigned therapy".Ĭomment: insufficient information to enable judgement.īlinding of participants and personnel (performance bias)Ĭure was objectively assessed and lack of blinding could have affected results.īlinding of outcome assessment (detection bias) Random sequence generation (selection bias) The trial authors defined clinical cure as the presence of an ulcer re‐epithelialized totally and clinical improvement as regional lymph nodes resolution. Intervention 2: spectinomycin single 2 g intramuscularly (71 participants).Īt 7 and 10 days following initiation of therapy and approximately 1 week later (days 14‐21) repeated clinical assessments were made and microbiological investigations performed to assess if the ulcer had not re‐epithelialized, if the regional lymph nodes had become fluctuant, or if an inguinal or femoral ulcer had formed or persisted. Intervention 1: erythromycin base, 500 mg oral 3 times daily for 5 days (69 participants).
All participants were asked to refrain from sexual contact and to return for follow‐up examinations between day 7 and day 10 following initiation of therapy and approximately 1 week later (days 14‐21). Blood was obtained by venepuncture for syphilis (RPR and FT A‐Abs tests) and chlamydial micro‐IF serology. Swabs were also taken directly from lesions for isolation of C trachomatis and HSV. After material had was obtained for darkfield microscopy, swabs were taken for isolation of H ducreyi from the bases of lesions and, where applicable, aspirates were obtained from fluctuant lymph nodes. The characteristics of any associated inguinal or femoral lymphadenopathy were recorded. Genital examination performed, and presence and clinical details of any genital ulceration noted. In addition, they had to be available for follow‐up examination and should not have received any antimicrobial chemotherapy during the preceding 7 daysĮxclusion criteria: People were subsequently excluded if either HSV or Chlamydia trachomatis were isolated from their lesions, or if attempts to isolate Haemophilus ducreyi from genital lesions at the initial visit were unsuccessful.īaseline characteristics: aetiological diagnose. Participants were included if dark‐field examination proved to be negative for Treponema pallidum.
If there was > 1 ulcer, the largest ulcer was selected for study. painful, non‐indurated lesions with purulent bases. Inclusion criteria: migrant mine workers with genital ulcers consistent with a clinical diagnosis of chancroid, i.e. Trial design: single‐centre, parallel, randomized controlled trial, 2 arms.Įthical issues: ethical board and signed consent. Setting: South Africa, outpatient clinic.
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