R01AI161019

Cumulative Burden of Chlamydia trachomatis and Mycoplasma genitalium in the US: Implications for Screening Guidelines and Antimicrobial Resistance - Abstract

Significant morbidity and healthcare costs are associated with Chlamydia trachomatis (CT) and Mycoplasma genitalium (MG) infections. Each is associated with male and female reproductive tract syndromes, yet each presents unique challenges for control.

CT is the most commonly reported nationally notifiable condition in the US and is a known cause of pelvic inflammatory disease (PID) and infertility. Despite longstanding control programs, CT rates are at an all-time high, and the utility and cost-effectiveness of CT prevention efforts are debated. As most CT infections are asymptomatic, our current understanding of the epidemiology and the effectiveness of CT control programs has depended entirely on case detection through screening, which is only targeted to select populations (women <25 years and other high-risk persons).

Much less is known about CT in women =25 who are infrequently screened, and screening is not recommended for men who have sex with women (MSW). These major gaps in our understanding have limited our ability to effectively target CT prevention programs to men and women at the highest risk of infection.

MG is a more recently emerged pathogen, responsible for 20-30% of male urethritis. There is no national MG surveillance, and despite general agreement that MG causes male urethritis, there is no consensus about whether it causes sequelae in women. Limited population-based estimates of urogenital MG prevalence exist, yet prevalent infections are often a poor predictor of lifetime experience of PID and infertility and permit only partial understanding of population-level epidemiology.

Antimicrobial resistance (AMR) in MG is rapidly expanding - MG is one of three bacteria on the CDC's 2019 Watch List of AMR threats - but AMR prevalence estimates are derived from high-risk STD clinic populations, and there are no nationally representative data.

A better understanding of the population-level epidemiology of CT and MG is critical to improving control efforts for each. To achieve this, we will conduct a seroepidemiologic study in the National Health and Nutrition Examinations Survey (NHANES) 2017-2018 cycle, using a novel serologic assay for CT that differentiates IgG isotypes to distinguish recent from distant infection, and a more sensitive and specific seroassay for MG. We will also identify AMR in urine specimens from MG-positive persons in NHANES 2017-2018. Finally, we will develop an individual-based CT and MG transmission dynamics model.

Using these outputs, we will:
1. Estimate the lifetime prevalence of CT in US men and characterize factors associated with recent versus past infection among men and women.
2. Estimate the seroprevalence and correlates of MG infection in US men and women, determine the association between prior MG infection and self-reported PID and infertility, and estimate the prevalence and correlates of macrolide and quinolone resistance in MG.
3. Evaluate the impact of CT and MG screening scenarios on reproductive health and treatment outcomes in mathematical models.

These data will provide critical information to either support or change current CT screening guidelines and to inform nascent national testing and treatment recommendations for MG.

University Of Washington

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Seattle, Washington 981951016 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the total obligations have increased 374% from $648,979 to $3,074,527.