Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness
Information source: Centers for Disease Control and Prevention
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Onchocerciasis
Intervention: Rifampin (Drug); Azithromycin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s):
Josef Amann, MD, MPH, Principal Investigator, Affiliation: CDC/NCID/DPD
Summary
The purpose of this study is to determine whether rifampin and/or azithromycin are effective
in the treatment of river blindness (onchocerciasis).
Clinical Details
Official title: Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months
Secondary outcome: Elimination of microfilaria in skin snips and histological examination of worms after 9 months
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
Minimum age: 5 Years.
Maximum age: N/A.
Gender(s): 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 that might interact with rifampin
- Clinical evidence of liver disease (jaundice, swollen abdomen)
- Clinical evidence of chronic disease/alcoholism
Locations and Contacts
Universidad del Valle/MERTU, Guatemala City, Guatemala
Additional Information
Starting date: July 2003
Ending date: May 2004
Last updated: August 23, 2005
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