Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Collaborators:	Universidad del Valle, Guatemala University of Alabama at Birmingham
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00127504

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala

Resource links provided by NLM:

Drug Information available for: Rifampin Azithromycin

U.S. FDA Resources

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

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

Locations

Guatemala
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

Investigators

Principal Investigator:

Josef Amann, MD, MPH

CDC/NCID/DPD

More Information

No publications provided

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

Keywords provided by Centers for Disease Control and Prevention:

Onchocerciasis
Wolbachia
Therapy

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases, Parasitic
Skin Diseases
Onchocerciasis
Filariasis
Enzyme Inhibitors
Nematode Infections
Pharmacologic Actions
Antibiotics, Antitubercular
Anti-Bacterial Agents

Spirurida Infections
Rifampin
Skin Diseases, Infectious
Therapeutic Uses
Azithromycin
Parasitic Diseases
Antitubercular Agents
Helminthiasis
Nucleic Acid Synthesis Inhibitors
Leprostatic Agents
Secernentea Infections

ClinicalTrials.gov processed this record on February 08, 2010