Ignite Creation Date:
2024-05-06 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03632109
Status:
TERMINATED
Last Update Posted:
2020-08-10
First Post:
2018-07-03
Brief Title:
Gent for Pharyngeal Gonorrhea GC
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Gentamicin for Pharyngeal Gonorrhea - A Demonstration Study
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Centers for Disease Control and Prevention has identified antimicrobial-resistant AMR Neisseria gonorrhoeae NG as one of the nations top three urgent AMR threats Since the advent of antibiotics in the 1930s NG has developed resistance to every first-line antibiotic Parenteral third-generation cephalosporins are now the only class of drug with consistent efficacy against NG New therapies are urgently needed Although some novel antimicrobials are under development reevaluating older drugs is another option for quickly identifying additional treatments for gonorrhea We propose a demonstration study to test a single dose of gentamicin for the treatment of pharyngeal gonorrhea We chose to focus on pharyngeal gonorrhea because these infections are common play an important role in fostering gonococcal resistance and are harder to eradicate than genital infections Although gentamicin is 91 efficacious for genital NG its efficacy at the pharynx may be less since streptomycin another aminoglycoside previously used to treat gonorrhea was not effective for pharyngeal NG It is unknown if streptomycins poor efficacy is indicative of limitations of aminoglycosides as a class We plan to enroll 60 men who have sex with men in a demonstration study to be conducted at the Seattle King County STD Clinic to test the efficacy of 360 mg of gentamicin given intramuscularly for pharyngeal gonorrhea Secondary objectives include determining the ideal pharmacodynamic criterion comparing in vitro minimal inhibitory concentrations MIC of NG to peak gentamicin serum levels estimating resistance induction among treatment failures and assessing the tolerability of 360 mg of IM gentamicin
Objectives
The proposed study aims to evaluate the efficacy of a single intramuscular IM dose of gentamicin in the treatment of pharyngeal gonorrhea Secondary objectives include documenting the efficacy stratified by minimal inhibitory concentration MIC compared with the gentamicin peak level in order to estimate a pharmacodynamic criterion We will also attempt to determine whether gentamicin monotherapy induces antimicrobial resistance among treatment failures Lastly we will evaluate the tolerability of 360 mg of IM gentamicin stratified by subject weight ie weight based dosing The specific aims are
1 Determine the proportion of persons whose pharyngeal gonococcal infections are cured with a single dose of 360mg gentamicin intramuscularly alone
2 Evaluate the renal safety and tolerability of 360mg IM of gentamicin
3 Document mean peak gentamicin levels following 360mg IM of gentamicin stratified by weight
4 Estimate the best pharmacodynamics criterion ie peakMIC ratio for pharyngeal gonorrhea treated with gentamicin using individual and mean peak gentamicin levels and NG isolate MIC
5 Among treatment failures conduct exploratory analyses comparing pre- and post-treatment MIC for evidence of induced resistance
Objectives
The proposed study aims to evaluate the efficacy of a single intramuscular IM dose of gentamicin in the treatment of pharyngeal gonorrhea Secondary objectives include documenting the efficacy stratified by minimal inhibitory concentration MIC compared with the gentamicin peak level in order to estimate a pharmacodynamic criterion We will also attempt to determine whether gentamicin monotherapy induces antimicrobial resistance among treatment failures Lastly we will evaluate the tolerability of 360 mg of IM gentamicin stratified by subject weight ie weight based dosing The specific aims are
1 Determine the proportion of persons whose pharyngeal gonococcal infections are cured with a single dose of 360mg gentamicin intramuscularly alone
2 Evaluate the renal safety and tolerability of 360mg IM of gentamicin
3 Document mean peak gentamicin levels following 360mg IM of gentamicin stratified by weight
4 Estimate the best pharmacodynamics criterion ie peakMIC ratio for pharyngeal gonorrhea treated with gentamicin using individual and mean peak gentamicin levels and NG isolate MIC
5 Among treatment failures conduct exploratory analyses comparing pre- and post-treatment MIC for evidence of induced resistance
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23AI113185 | NIH | None | httpsreporternihgovquickSearchK23AI113185 |