U01AI157962

FOCAL MASS DRUG ADMINISTRATION (FMDA) TO REDUCE PLASMODIUM VIVAX TRANSMISSION, A PRAGMATIC CLUSTER RANDOMIZED CONTROLLED TRIAL IN PERU - PROJECT SUMMARY/ABSTRACT

IN MOST COUNTRIES APPROACHING ELIMINATION, PLASMODIUM VIVAX (PV) REPRESENTS AN INCREASING PROPORTION RELATIVE TO P. FALCIPARUM (PF). MASS DRUG ADMINISTRATION (MDA), AS A WAY TARGET SUBPATENT, ASYMPTOMATIC INFECTIONS, IS RECOMMENDED FOR P. FALCIPARUM ELIMINATION, BUT THE RECOMMENDATION DOES NOT EXTEND TO P. VIVAX GIVEN LIMITED EVIDENCE, TOOLS, AND SAFETY CONCERNS.

THE OBJECTIVE OF OUR STUDY IS TO EVALUATE THE LONG-TERM IMPACT, SAFETY, AND COST-EFFECTIVENESS OF FOCAL MDA (FMDA) FOR PV TRANSMISSION REDUCTION. TO TEST OUR HYPOTHESIS THAT FMDA, IN ADDITION TO STANDARD AGGRESSIVE INTERVENTIONS, WILL SAFELY REDUCE TRANSMISSION, WE PROPOSE A 3-YEAR OPEN-LABEL CRCT IN THE LOW ENDEMIC SETTING OF LORETO REGION, PERU.

VILLAGES OR CLUSTERS WILL BE RANDOMIZED TO CONTROL OR FMDA. THE CONTROL ARM WILL RECEIVE STANDARD INTERVENTIONS (VECTOR CONTROL, SYMPTOMATIC CASE MANAGEMENT, AND ACTIVE CASE DETECTION OF ASYMPTOMATIC CASES). THE TREATMENT ARM WILL RECEIVE STANDARD INTERVENTIONS PLUS FMDA, WHICH WILL UTILIZE A NEW DRUG FOR RADICAL CURE OF P. VIVAX, TAFENOQUINE, AND A NEW QUANTITATIVE GLUCOSE 6 PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENCY RAPID TEST TO SUPPORT SAFE ADMINISTRATION OF TAFENOQUINE.

FMDA WILL BE TARGETED TO CONSENTING AND ELIGIBLE HIGH-RISK VILLAGERS, DEFINED AS HOUSEHOLD MEMBERS AND NEIGHBORS OF RECENT PV INDEX CASES. FMDA WILL BE CONDUCTED IN 2 ROUNDS PER YEAR, TWO MONTHS APART DURING THE LOW MALARIA SEASON, AND OVER 3 YEARS. ELIGIBILITY WILL BE RE-ASSESSED EACH YEAR, AND PRIOR TO EACH FMDA ROUND.

SPECIFIC AIMS ARE TO: 1) DETERMINE THE EFFECTIVENESS OF FMDA TO REDUCE PV TRANSMISSION AS MEASURED IN A PRIMARY OUTCOME OF INCIDENCE AND SECONDARY OUTCOMES OF INFECTION PREVALENCE, SEROPREVALENCE, AND GENETIC DIVERSITY; 2) EVALUATE THE SAFETY AND TOLERABILITY OF FMDA; AND 3) MEASURE THE COST-EFFECTIVENESS OF FMDA.

TO MAXIMIZE

San Francisco Regents Of The University Of California

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]

San Francisco, California 94143 United States

Single Zip Code

NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) (PAR-21-083)

Amendment Since initial award the total obligations have increased 289% from $1,293,493 to $5,036,878.