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

Onchocerciasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127504
• Other study ID #: CDC-NCID-3843
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2005
• Last updated: August 23, 2005
• Start date: July 2003
• Est. completion date: May 2004

Study information

• Verified date: August 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Males and non-pregnant/non lactating females >5 years of age

• One onchocercal nodule in an anatomical position where it can be easily removed surgically

Exclusion Criteria:

• Pregnancy (based on urine pregnancy test)

• Breast-feeding

• Women taking oral contraceptives

• Allergy or other adverse reaction to either medication

• Use of other medications that might interact with rifampin

• Clinical evidence of liver disease (jaundice, swollen abdomen)

• Clinical evidence of chronic disease/alcoholism

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Onchocerciasis

Intervention

Drug:
• Rifampin

• Azithromycin

Locations

Country	Name	City	State
Guatemala	Universidad del Valle/MERTU	Guatemala City

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Universidad del Valle, Guatemala, University of Alabama at Birmingham

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
Secondary	Elimination of microfilaria in skin snips and histological examination of worms after 9 months