Onchocerciasis Clinical Trial
Official title:
Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
Mass treatment with ivermectin (Mectizan, Merck & Co) is the mainstay of the current efforts
to control onchocerciasis, but the drug is not lethal to adult Onchocerca volvulus
parasites. Wolbachia, an endosymbiotic bacterium necessary for the fecundity of O. volvulus,
can be eradicated with four-six week courses of doxycycline, but this cannot be implemented
in current mass drug administration programs. The purpose of this study is to evaluate if a
shorter course (five days) with antibiotics that could be used in children and potentially
pregnant women would likewise be effective.
Guatemalan patients with onchocercal nodules will be enrolled in an open label trial with
four treatment groups: Group A (rifampin 20 mg/kg by mouth [po; maximum 600 mg/day]); B
(azithromycin 12 mg/kg po [maximum 500 mg/day]); C (combination of rifampin 20 mg/kg po
[maximum 600 mg/day] and azithromycin 12 mg/kg po [maximum 500 mg/day]); D (control group,
multivitamin). At the end of the five day treatment course all participants will receive a
single dose of ivermectin (150 mcg/kg).
Nodulectomies will be performed 9 months after treatment and the O. volvulus will be
analyzed by immunohistochemical staining specific for Wolbachia.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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