Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127504
Recruitment Status : Completed
First Posted : August 8, 2005
Last Update Posted : August 24, 2005
Universidad del Valle, Guatemala
University of Alabama at Birmingham
Information provided by:
Centers for Disease Control and Prevention

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

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: Rifampin Drug: Azithromycin Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
Study Start Date : July 2003
Study Completion Date : May 2004

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127504

Layout table for location information
Universidad del Valle/MERTU
Guatemala City, Guatemala
Sponsors and Collaborators
Centers for Disease Control and Prevention
Universidad del Valle, Guatemala
University of Alabama at Birmingham
Layout table for investigator information
Principal Investigator: Josef Amann, MD, MPH CDC/NCID/DPD
Layout table for additonal information Identifier: NCT00127504    
Other Study ID Numbers: CDC-NCID-3843
First Posted: August 8, 2005    Key Record Dates
Last Update Posted: August 24, 2005
Last Verified: August 2005
Keywords provided by Centers for Disease Control and Prevention:
Additional relevant MeSH terms:
Layout table for MeSH terms
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers