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

NCT ID: NCT00127504

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2004-05-31

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 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.

Conditions

Onchocerciasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rifampin

Intervention Type: DRUG

Azithromycin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad del Valle, Guatemala

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Principal Investigators

Josef Amann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

CDC/NCID/DPD

Locations

Universidad del Valle/MERTU

Guatemala City, , Guatemala

Countries

Guatemala

Other Identifiers

CDC-NCID-3843

Identifier Type: -

Identifier Source: org_study_id