Azithromycin |
Zithromax |
Clinical Trial: Clinical Trial of Rifampin and Azithromycin for the Treatment of Riverblindness
This study has been completed.
|
Purpose
| 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
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
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
Josef Amann, MD, MPH, Principal Investigator, CDC/NCID/DPD
More Information
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
Resources
- Azithromycin (Drug Digest)
- Zithromax (Drug Digest)

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