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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

August 4, 2005
August 23, 2005
July 2003
Not Provided
Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 month
Complete list of historical versions of study NCT00127504 on ClinicalTrials.gov Archive Site
Elimination of microfilaria in skin snips and histological examination of worms after 9 months
Elimination of microfilaria in skin snips and histological examination of worms after 9 month
Not Provided
Not Provided
 
Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness
Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Onchocerciasis
  • Drug: Rifampin
  • Drug: Azithromycin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2004
Not Provided

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
Both
5 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Guatemala
 
NCT00127504
CDC-NCID-3843
Not Provided
Not Provided
Centers for Disease Control and Prevention
  • Universidad del Valle, Guatemala
  • University of Alabama at Birmingham
Principal Investigator: Josef Amann, MD, MPH CDC/NCID/DPD
Centers for Disease Control and Prevention
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP