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Clinical Trial of Rifampin and Azithromycin for the Treatment of Riverblindness - Article


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Azithromycin

Zithromax 




Clinical Trial: Clinical Trial of Rifampin and Azithromycin for the Treatment of Riverblindness

This study has been completed.

Sponsors and Collaborators: Centers for Disease Control and Prevention
Universidad del Valle, Guatemala
University of Alabama, 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 Riverblindness.
Condition Intervention Phase
Onchocerciasis
 Drug: Rifampin and Azithromycin
Phase II

MedlinePlus related topics:  Parasitic Diseases

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

Further Study Details: 
Primary Outcomes: Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 month
Secondary Outcomes: Elimination of microfilaria in skin snips and histological examination of worms after 9 month
Expected Total Enrollment:  80

Study start: July 2003;  Study completion: September 2005
Last follow-up: May 2004;  Data entry closure: February 2005

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 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 above,  Genders Eligible for Study:  Both
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 (See Appendix 5) that might interact with rifampin
  • clinical evidence of liver disease (jaundice, swollen abdomen)
  • clinical evidence of chronic disease/alcoholism

Location Information


Guatemala
      Universidad del Valle/MERTU, Guatemala City,  Guatemala

Study chairs or principal investigators

Josef Amann, MD, MPH,  Principal Investigator,  CDC/NCID/DPD   

More Information

Study ID Numbers:  CDC-NCID-3843
Last Updated:  August 5, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00127504
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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Page Updated: June 1, 2005
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