drugset / Trial / NCT00926796

Efficacy of Combination Therapies for Gonorrhea Treatment

NCT00926796

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However, some gonorrhea is not cured with a single antibiotic. The study will look at how well treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2 treatment groups each receiving a combination of 2 antibiotics. Sites in the United States will recruit 500 male and female participants. Participants must be 15 to 60 years old, in good health and identified in participating sexually transmitted disease clinics as having uncomplicated cervical or urethral gonorrhea. Procedures include collection of current symptoms, medical and sexual history, sexual orientation, vital signs, height, weight, cervical/urethral cultures and clinical examinations. Volunteers will be involved for about 17 days.

Timeline

Start
2010-06
Primary completion
2012-12
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 2 g Oral
Subject Gemifloxacin Small molecule 320 mg Oral
Subject Gentamicin Small molecule 5 mg/kg Intramuscular
Subject Gentamicin Small molecule 240 mg Intramuscular

Indications