Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838717
Status:
UNKNOWN
Last Update Posted:
2022-10-31
First Post:
2021-01-29
Brief Title:
Clinical Trial of Doxycycline VS BPG for Early Syphilis SY-DOXY
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Randomized Non-Inferiority Clinical Trial of Doxycyline Vs BPG for Early Syphilis
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
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:
SY-DOXY
Brief Summary:
According to European and US Centers for Disease Control and Prevention CDC guidelines the recommended treatment for uncomplicated early syphilis in adults ie primary secondary and early latent is a single intramuscular injection of 24 million units of benzathine benzylpenicillin G BPG Recent reviews have also recommended BPG as the first-line treatment of early syphilis reporting a success rate of more than 90 over a large panel of studies This form of the drug provides weeks of treponemicidal levels of penicillin in the blood but does not efficiently cross the blood-brain barrier
However despite the use of BPG for almost 70 years and its status as the gold standard treatment for early syphilis the need to administer this antibiotic parenterally has led to the use of second-line oral antibiotics including firstgeneration macrolides and then second-generation macrolides such as azithromycin Several African studies have shown 1 g azithromycin bid treatment for one day to be effective against early syphilis but most authors agree that azithromycin should not generally be used as resistance to this macrolide is highly prevalent in Western countries Moreover a recent study by our group showed that more than 80 of the treponemal strains isolated in France harbor the mutation conferring resistance to azithromycin The use of this alternative would therefore be highly unlikely to be effective in France Tetracycline antibiotics have also been proposed as an alternative in patients with a contraindication for BPG or other forms of penicillin Doxycycline at a dose of 100 mg orally twice daily for 14 days has been endorsed as a preferred alternative treatment but few data are available concerning its efficacy This issue is crucial for two main reasons there has been a recrudescence of early syphilis in most western countries over the last 20 years increasing the need for BPG and two periods of BPG shortage were experienced in 2013 and 2017 leading to the use of alternative treatments due to the temporary unavailability of BPG or its limitation to cases in which no other treatment was possible Data for the manufacturing and distribution of antibiotics are not publicly available but reports of limited availability shortages and price increases for old antibiotics suggest that the current system is too fragile to provide what should be a given in modern medicine access to effective treatment for common and potentially severe bacterial infections The recurrence of BPG shortages over the last five years has created an urgent need to demonstrate that doxycycline is safe or at least as safe as BPG for treating early syphilis The investigators hypothesize that the recommended doxycycline regimen is not inferior to BPG and plan to test this hypothesis in a randomized clinical trial
However despite the use of BPG for almost 70 years and its status as the gold standard treatment for early syphilis the need to administer this antibiotic parenterally has led to the use of second-line oral antibiotics including firstgeneration macrolides and then second-generation macrolides such as azithromycin Several African studies have shown 1 g azithromycin bid treatment for one day to be effective against early syphilis but most authors agree that azithromycin should not generally be used as resistance to this macrolide is highly prevalent in Western countries Moreover a recent study by our group showed that more than 80 of the treponemal strains isolated in France harbor the mutation conferring resistance to azithromycin The use of this alternative would therefore be highly unlikely to be effective in France Tetracycline antibiotics have also been proposed as an alternative in patients with a contraindication for BPG or other forms of penicillin Doxycycline at a dose of 100 mg orally twice daily for 14 days has been endorsed as a preferred alternative treatment but few data are available concerning its efficacy This issue is crucial for two main reasons there has been a recrudescence of early syphilis in most western countries over the last 20 years increasing the need for BPG and two periods of BPG shortage were experienced in 2013 and 2017 leading to the use of alternative treatments due to the temporary unavailability of BPG or its limitation to cases in which no other treatment was possible Data for the manufacturing and distribution of antibiotics are not publicly available but reports of limited availability shortages and price increases for old antibiotics suggest that the current system is too fragile to provide what should be a given in modern medicine access to effective treatment for common and potentially severe bacterial infections The recurrence of BPG shortages over the last five years has created an urgent need to demonstrate that doxycycline is safe or at least as safe as BPG for treating early syphilis The investigators hypothesize that the recommended doxycycline regimen is not inferior to BPG and plan to test this hypothesis in a randomized clinical trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003278-21 | EUDRACT_NUMBER | None | None |