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Azithromycin/Bicillin for treatment of early syphilis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Azithromycin/Bicillin for treatment of early syphilis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Azithromycin/Bicillin for treatment of early syphilis Clinical research trials and Azithromycin/Bicillin for treatment of early syphilis health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Azithromycin/Bicillin for treatment of early syphilis. Azithromycin/Bicillin for treatment of early syphilis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Azithromycin/Bicillin for treatment of early syphilis clinical trial. Subjects frequently get the best healthcare possible for their Azithromycin/Bicillin for treatment of early syphilis condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Azithromycin/Bicillin for treatment of early syphilis  Azithromycin/Bicillin for treatment of early syphilis
Azithromycin/Bicillin for treatment of early syphilis
For Condition: Syphilis
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine if azithromycin (2.0 grams administered orally as a single dose), a drug approved for treatment of other infections, is as effective for syphilis therapy as the usual penicillin treatment (penicillin Benzathine G - 2.4 million units). This study is considered research because azithromycin is not licensed for the treatment of syphilis. In addition, in a substudy population of subjects allergic to penicillin, the efficacy of azithromycin will be compared with the currently recommended alternative treatment, doxycycline (100 mg twice daily for 14 days).
Details: Syphilis is a disease with a worldwide distribution. It causes genital ulceration, thereby amplifying risk for HIV acquisition and transmission; may cause congenital infection, spontaneous abortion, and stillbirth if untreated in pregnant women; and in about one-third of all cases, if untreated, results in late sequelae which include neurosyphilis, gumma formation and cardiovascular involvement. The purpose of this study is to evaluate the efficacy of azithromycin as therapy for early syphilis. Specifically, this study will evaluate the efficacy of azithromycin for treatment of syphilis compared to the current recommended treatment, benzathine penicillin G.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Active Control, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Age 18 to 55. - Must sign written informed consent. - Have untreated primary, secondary, or early latent syphilis. - Are not pregnant or lactating. - Are willing to have an HIV test and participate in HIV counseling and return to the clinic for followup treatment. EXCLUSION CRITERIA: - Have a known or suspected allergy to macrolide or azalide antibiotics. - Have a known or suspected STD, other than syphilis, requiring treatment. - Have used antibiotics active against T. pallidum in the preceding 30 days. - Are known to be HIV positive prior to enrollment. - Have suspected or known drug use that might interfere with study participation and followup treatment. - Have used any investigational drugs in the past 30 days.
Total Enrollment: 600
Location and Contact Information:
University of North Carolina Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-70
United States
Recruiting
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294
United States
Recruiting
Indiana University *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting
Louisiana State University Medical Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
Durham County Health Department Laboratory *Recruiting*
Durham, North Carolina, 27701
United States
Recruiting
Madagascar Hospital Kely *Recruiting*
Tamatave, ,
Madagascar
Recruiting
Institut d'Hygiene Sociale *Recruiting*
Antananarivo, ,
Madagascar
Recruiting
Wake County Human Services Laboratory, UNC *Recruiting*
Raleigh, North Carolina, 27610
United States
Recruiting
Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting
Additional Information:
Study ID Numbers: 99-005;
Study Start Date: November 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031499
Other Syphilis Studies:
1. Azithromycin/Bicillin for treatment of early syphilis
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Azithromycin/Bicillin for treatment of early syphilis
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