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Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness

Centers for Disease Control and Prevention (CDC) logo

Centers for Disease Control and Prevention (CDC)

Status and phase

Completed
Phase 2

Conditions

Onchocerciasis

Treatments

Drug: Rifampin
Drug: Azithromycin

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00127504
CDC-NCID-3843

Details and patient eligibility

About

The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).

Full 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.

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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