The objective of the present prospective, noncomparative, multicenter
study was to assess the safety and efficacy of gentamicin and doxycycl
ine therapy for human brucellosis, In the first part of the study, a c
ohort of 17 patients received 100 mg of doxycycline (or 5 mg/kg of bod
y weight per day if the body weight was <40 kg) orally every 12 h for
45 days (cohort 1), In the second part of the study a subsequent cohor
t of 35 patients was treated with doxycycline at the same dosage for 3
0 days (cohort 2), All patients were treated intramuscularly with gent
amicin at 240 mg (or 5 mg/kg per day if the body weight was <50 kg) on
ce daily for the first 7 days, Both cohorts showed a favorable respons
e during therapy, and there were no therapeutic failures, Relapse was
noted in 1 (5.9%; 95% confidence interval [95% CI], 0.15 to 28.7%) of
the 17 patients in cohort 1 and in 8 (22.9%; 95% CI, 10.4 to 40.1%) of
the 35 patients in cohort 2, Nineteen patients (36.5%; 95% CI, 23.6 t
o 51.0%) had adverse effects, with no differences between cohorts, and
no patients had a treatment-limiting adverse effect, The study indica
tes that the combination of doxycycline for 45 days and gentamicin for
7 days is an effective and well tolerated therapy for human brucellos
is. The relapse rates obtained with doxycycline treatment for 30 days
appear to be higher than those obtained with doxycycline treatment for
Jj days.