You are here

POC Diagnostic for Gonorrhea and Determination of Antimicrobial Susceptibility

Description:

 

POC Diagnostic for Gonorrhea and Determination of Antimicrobial Susceptibility

Fast-Track proposals will be accepted Number of anticipated awards: 1-2 Budget (total costs, per award): Phase I: up to $300,000 for up to 1 year; Phase II: up to $1,500,000 for up to 3 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Page 125

Background:

There are over 450,000 cases of gonorrhea reported in the U.S. annually. Of particular concern is that the causative agent, Neisseria gonorrhoeae, is naturally competent and easily acquires resistance to antimicrobials. The U.S. Centers for Disease Control and Prevention changes the recommendation for the treatment of gonorrhea when surveillance data indicate ≥5% resistance to the class of antimicrobial being used at the time. Over the last several decades this change has been implemented numerous times, such that the cephalosporins are the last class of antimicrobials left to treat gonorrhea. Cephalosporin resistance is increasing worldwide, and the loss of this antibiotic as a treatment option would make gonorrhea clinically untreatable. However, since treatment recommendations are based on ≥5% resistance, it is clear that the vast majority of circulating isolates are still sensitive to previously-recommended classes of antimicrobials. Re-introduction of these classes of antimicrobials into clinical use would allow for the continued successful treatment of gonorrhea even if cephalosporin resistance becomes widespread. In order to best select the appropriate and most effective therapy, clinicians need real-time antimicrobial sensitivity tests to characterize phenotypes of infecting N. gonorrhoeae strains.

Project goal:

The goal of this project is to develop a rapid (≤ one hour) point-of-care diagnostic capable of: i) identifying N. gonorrhoeae; and ii) determining the infecting strain’s susceptibility to at least three classes of antibiotics (e.g. quinolones, macrolides, etc.) directly from the patient sample (e.g. urine, urethral/vaginal/cervical swab).

Phase I activities may include:

Development of a prototype product that demonstrates the rapid determination of the antimicrobial susceptibility profile of one or more N. gonorrhoeae isolates

• Integration of platform to rapidly identify N. gonorrhoeae and antimicrobial susceptibility

• Development of sample preparation methods consistent with the product platform

Phase II activities may include:

Integration of platform to rapidly identify N. gonorrhoeae and antimicrobial susceptibility

• Development of sample preparation methods consistent with the product platform

• Further development of the prototype product to determine performance characteristics

• Final validation testing and scale-up manufacturing of test kits

This SBIR Topic will not support:

The design and conduct of clinical trials (see Appendix H.1 for the NIH definition of a clinical trial).

For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.

NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)

NIDA’s mission is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health.

This involves:

• Strategically supporting and conducting basic and clinical research on drug use (including nicotine), its consequences, and the underlying neurobiological, behavioral, and social mechanisms involved.

• Ensuring the effective translation, implementation, and dissemination of scientific research findings to improve the prevention and treatment of substance use disorders and enhance public awareness of addiction as a brain disorder.

US Flag An Official Website of the United States Government