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| 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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | May 2004 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Guatemala | |
| Universidad del Valle/MERTU | |
| Guatemala City, Guatemala | |
| Principal Investigator: | Josef Amann, MD, MPH | CDC/NCID/DPD |
More Information
| ClinicalTrials.gov Identifier: | NCT00127504 History of Changes |
| Other Study ID Numbers: | CDC-NCID-3843 |
| Study First Received: | August 4, 2005 |
| Last Updated: | August 23, 2005 |
| Health Authority: | United States: Federal Government |
|
Onchocerciasis Wolbachia Therapy |
|
Onchocerciasis Onchocerciasis, Ocular Filariasis Spirurida Infections Secernentea Infections Nematode Infections Helminthiasis Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Eye Infections, Parasitic Eye Infections |
Eye Diseases Rifampin Azithromycin Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors |
