Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031499
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2002-03-06
Brief Title:
AzithromycinBicillin Syphilis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Equivalence Trial of Azithromycin vs Benzathine Penicillin for the Treatment of Early Syphilis
Status:
COMPLETED
Status Verified Date:
2013-04
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 if azithromycin a drug approved for treatment of other infections is as effective for syphilis a sexually transmitted disease as the standard treatment Approximately 600 healthy adults who are HIV-negative ages 18 to 55 years of age with primary secondary or early latent syphilis will participate in this research study Volunteers will be enrolled in 5 US cities and in Madagascar Participants will be chosen randomly by chance to receive 1 of 2 study drugs benzathine penicillin given 2 shots in the buttocks or 4 tablets of azithromycin Subjects who report a history of a penicillin allergy will be given either 20 g of oral azithromycin or 100 mg doxycycline taken orally twice a day for 14 days Over 2 years 10 visits will be required Procedures will include blood samples physical exams and swabs of sores
Detailed Description:
Syphilis is a disease with a worldwide distribution It causes genital ulceration thereby amplifying risk for HIV acquisition and transmission and it may cause congenital infection spontaneous abortion and stillbirth if untreated in pregnant women About one third of all cases if untreated result in late sequelae which include neurosyphilis gumma formation and cardiovascular involvement This study will be a multi-center randomized open-label trial to evaluate the efficacy of azithromycin in treating primary secondary and early latent syphilis in HIV Human Immunodeficiency Virus uninfected volunteers Up through version 60 of this protocol volunteers were only followed for 12 months The protocol was amended starting with version 70 to include follow-up visits at month 18 and 24 in order to capture possible late failures Each subject will be randomized into a treatment group If the subject does not have a self-reported history of penicillin allergy the subject will be randomized to receive either a single 20 gram dose of azithromycin administered orally or 24 million units of benzathine penicillin G administered intramuscularly once Eligible patients who report a history of penicillin allergy will be randomized using a separate randomization schedule to receive either a single dose of azithromycin or doxycycline 100 milligrams taken orally twice a day for 14 days Block randomization will be used within each clinical center with subjects allocated in equal numbers to either standard therapy or azithromycin Participants found to be ineligible for study participation after they have been randomized and treated will be treated again with benzathine penicillin G or doxycycline if they are allergic to penicillin and will continue follow-up for safety evaluation The treatment assignments will not be blinded No attempt will be made to recruit a sufficient sample size among penicillin allergic subjects to attain the desired power for the primary outcome Therefore these results will be seen as preliminary to a possible future trial and as confirmatory to the primary comparison Although the study endpoint will be determined at 6 months all participants will have follow-up visits for 2 full years At the end of the 6 month evaluation period all participants will have been classified in one of the following groups cure clinical responseserological nonresponse or failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None