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

This study has been completed.
Sponsor:
Collaborators:
Universidad del Valle, Guatemala
University of Alabama at Birmingham
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00127504
First received: August 4, 2005
Last updated: August 23, 2005
Last verified: August 2005
  Purpose

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


Condition Intervention Phase
Onchocerciasis
Drug: Rifampin
Drug: Azithromycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

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

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

Estimated Enrollment: 80
Study Start Date: July 2003
Estimated Study Completion Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127504

Locations
Guatemala
Universidad del Valle/MERTU
Guatemala City, Guatemala
Sponsors and Collaborators
Universidad del Valle, Guatemala
University of Alabama at Birmingham
Investigators
Principal Investigator: Josef Amann, MD, MPH CDC/NCID/DPD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127504     History of Changes
Other Study ID Numbers: CDC-NCID-3843
Study First Received: August 4, 2005
Last Updated: August 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Onchocerciasis
Wolbachia
Therapy

Additional relevant MeSH terms:
Onchocerciasis
Onchocerciasis, Ocular
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Eye Infections, Parasitic
Eye Infections
Eye Diseases
Rifampin
Azithromycin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014