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Clinical Trial
Comparative Study
English Abstract
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
[A comparative therapeutic and multicenter trial of rifampicin and doxycycline versus streptomycin and doxycycline in human brucellosis].
Medicina Clínica 1991 May 5
BACKGROUND: Comparison and evaluation of the efficacy and safety of two treatment schedules in human brucellosis.
METHODS: A comparative, randomized, multicentric, open study of 45 days doxycycline plus rifampin in the initial 21 days (group A) versus 45 doxycycline plus streptomycin in the initial 14 days (group B). 42 were included in each group. The diagnosis of brucellosis was based on blood culture or consistent clinical findings and a Wright's serum agglutination titer of 1/160 or greater. Clinical and laboratory monitoring was carried out, including blood cultures on the days 7 and 48 and after 3, 6, and 12 months.
RESULTS: 38 patients in each group were evaluable at the end of treatment. 3 group A patients and 1 group B patient had initial therapeutic failure. 31 group A patients and 35 group B patients could be followed up during 6 months or more (mean follow up of 10.5 and 11.5 months, respectively). 9 relapses (29%) developed in group A and 2 (6%) in group B (p less than 0.05). 22 patients of the 34 finally evaluated in group A (65%) were considered as cured, versus 33 of the 36 in group B (92%) (p less than 0.01). Side effects not requiring withdrawal of the treatment developed in 12 patients, without differences between the two groups.
CONCLUSIONS: In the therapy of human brucellosis, the association of doxycycline (45 days) and rifampin (21 days) is less effective than the classical association of doxycycline and streptomycin.
METHODS: A comparative, randomized, multicentric, open study of 45 days doxycycline plus rifampin in the initial 21 days (group A) versus 45 doxycycline plus streptomycin in the initial 14 days (group B). 42 were included in each group. The diagnosis of brucellosis was based on blood culture or consistent clinical findings and a Wright's serum agglutination titer of 1/160 or greater. Clinical and laboratory monitoring was carried out, including blood cultures on the days 7 and 48 and after 3, 6, and 12 months.
RESULTS: 38 patients in each group were evaluable at the end of treatment. 3 group A patients and 1 group B patient had initial therapeutic failure. 31 group A patients and 35 group B patients could be followed up during 6 months or more (mean follow up of 10.5 and 11.5 months, respectively). 9 relapses (29%) developed in group A and 2 (6%) in group B (p less than 0.05). 22 patients of the 34 finally evaluated in group A (65%) were considered as cured, versus 33 of the 36 in group B (92%) (p less than 0.01). Side effects not requiring withdrawal of the treatment developed in 12 patients, without differences between the two groups.
CONCLUSIONS: In the therapy of human brucellosis, the association of doxycycline (45 days) and rifampin (21 days) is less effective than the classical association of doxycycline and streptomycin.
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