Clinical Trial: Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala

Brief Summary: The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).

Detailed Summary:

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.

Sponsor: Centers for Disease Control and Prevention

Current Primary Outcome: Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months

Original Primary Outcome: Same as current

Current Secondary Outcome: Elimination of microfilaria in skin snips and histological examination of worms after 9 months

Original Secondary Outcome: Same as current

Information By: Centers for Disease Control and Prevention

Dates:
Date Received: August 4, 2005
Date Started: July 2003
Date Completion: May 2004
Last Updated: August 23, 2005
Last Verified: August 2005