Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-31 @ 8:46 PM
Study NCT ID:
NCT00127504
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2005-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
Trial of Rifampin and Azithromycin for Treatment of Endosymbiotic Bacteria (Wolbachia) in Onchocerca Volvulus in Guatemala
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: