A. Antimicrobial Pharmacokinetics, Pharmacodynamics and General Pharmacology:

A1. Antimicrobial Pharmacokinetics
Relevant pharmacokinetic studies (including absorption, distribution, metabolism and elimination) of new antibacterials, antivirals, anti-HIV agents, antifungals and other anti-infectives (post-US IND) will be considered if they have not been previously reported or if they reflect unique observations. Studies on drug-drug interactions and the epidemiology, pathogenesis and prevention of drug toxicities are encouraged.

Studies examining the penetration of antimicrobials into normal tissues or sites that are rarely infected are discouraged unless they report a unique, clinically relevant observation. Pharmacokinetic studies limited to animals are also discouraged unless they provide findings relevant to humans or to experimental chemotherapy.

A2. Antimicrobial Pharmacodynamics
In vitro pharmacodynamic studies (e.g., post-antibiotic effects, sub-MIC effects) and those performed in humans, animals and in vitro models will be considered if they provide new information. The Program Committee is especially interested in studies correlating pharmacokinetic/pharmacodynamic (PK/PD) indices (e.g., time above MIC, peak/MIC ratio, AUC/MIC ratio) with therapeutic efficacy.

Since large numbers of pharmacodynamic studies in animals and in vitro models are being submitted to ICAAC, preference will be given to studies that include multiple organisms and/or multiple drugs including established agents as controls. In animal studies, the dosages used and the drug's pharmacokinetics should be provided. The concentrations obtained in the in vitro models should reflect those likely to be obtained in humans. Protein binding effects must also be considered. Monte-Carlo simulation studies will only be considered if full population PK analysis has been performed and incorporated in the analysis.

B. Therapy in Animal Models, Pathogenesis of Infectious Diseases, Molecular Basis for Pathogenicity, and Host Defenses
Abstracts reporting the effects and investigation of specific or nonspecific immunomodulating agents, the host immune response to infections, molecular studies into the pathogenesis and pathophysiology of a disease, and studies in animal models are welcome.

For therapeutic studies of antibacterials in animals, controls that validate the model must be included. New drugs or therapeutic regimens should be compared with clinically relevant standard therapy, and adequate numbers of animals must be used to permit appropriate statistical analysis. Dosage and duration of therapy must be carefully selected so as to produce concentrations in serum and tissue similar to those likely to be achieved in humans. Studies that elucidate principles or identify factors that influence the therapeutic efficacy of antimicrobial chemotherapy are encouraged even though they may not strictly meet these criteria. Studies correlating PK/PD parameters with therapeutic efficacy, however, should be submitted to category "A".

C1. Antibiotics:  Mechanisms of Action, Biochemistry and Genetics of Resistance (Antibacterial, not Viral or Fungal)
Abstracts are encouraged in the areas of mechanisms of action of and resistance to antibacterials, including studies of genetic elements causing or regulating resistance.  Abstracts dealing with viral or fungal resistance should be submitted to categories "H", "M" or "V", as appropriate

C2. Antibiotics:  Surveys and/or Molecular Epidemiology of Resistance and Resistance Genes, Strains or Serotypes (Antibacterial, not Viral or Fungal)
Abstracts on studies relating to surveillance and molecular epidemiology of antibiotic-resistant bacteria and resistance genes are appropriate. Other abstracts considered include novel assays and methods for detection of resistance genes, as well as analyses and comparisons of typing methods for differentiating strains. Priority will be given to unique abstracts that provide surveillance data on emergence or reductions in resistance of major public health importance.

D. Laboratory Tests for Diagnosing Infections; Methods for Antibacterial Susceptibility Testing
Abstracts presenting information on clinically relevant studies of recovery, enumeration, or characterization of microorganisms from clinical specimens will be considered. Also of interest are innovative methodologies and instrumentation, particularly when these techniques are faster or produce more clinically useful data. Repetitive trials or comparisons of instruments or methods will be acceptable only if different from those previously published or additional conclusions are reported. In addition, novel studies of in vitro susceptibility tests that address new methods, clinical relevance of results, and development of interpretive criteria are welcome. Laboratory diagnostic approaches for newly recognized infectious diseases are welcome. Diagnostic tools and susceptibility testing for sexually transmitted pathogens should be submitted to category “L”, while those for fungi should be submitted to category “M”, those for viruses submitted by category “V”, and those for parasites submitted to category “P”.

E. In Vitro Antibacterial Susceptibility Studies and Drug Combination Interactions
This category comprises MIC data and/or time-kill studies on relatively new drugs (those past IND filing in the US, or beyond phase I studies), and in vitro drug-combination interactions. MIC studies involving several institutions and a large number of strains are preferred. Other studies that will be considered include those in which the activities of various antimicrobial agents against a select or well-defined group of organisms are determined. These studies will be judged on the importance of the observation (e.g. antimicrobial activity of new agents against highly resistant strains) and its relevance to clinical medicine. The Program Committee requests that pharmaceutical companies help monitor the number of abstracts submitted on susceptibility studies on a new agent to avoid repetition. Splitting data for a similar agent or group of agents across different species should be avoided. Interaction studies (synergy, antagonism, etc.) should focus on clinically relevant combinations. In any case, a statistical evaluation should be provided.

F. New Antimicrobial Agents (i.e. pre-US IND or prior to the start of any clinical therapeutic studies) and New Research Technologies
Traditionally, ICAAC has served as a forum for the introduction of new antimicrobial agents.  The Program Committee will endeavor to concentrate all information on a new compound and technology in one session.  Structures of new agents must be presented in at least one poster in the session. Individual authors are discouraged from segregating closely related data into multiple abstracts.

F1. New Antimicrobial Agents (i.e. pre-US IND or prior to the start of any clinical therapeutic studies)
The Program Committee requests that the generic name of the drug should be included in the title of the abstract.  Abstracts dealing with the isolation, purification, and identification of new antimicrobial agents and the chemistry, structure-activity relationships, mechanisms of action, in vivo / in vitro microbiology, PK/PD in animals, and pre-US IND or non-US early phase 1 studies are given priority consideration.  These abstracts should contain meaningful data (e.g. producing organism, purification steps, physical-chemical characterization, structures, MICs, ED50s) to describe new compounds and their properties.

F2. New Research Technologies and Methodologies (in early stages of drug discovery)
ICAAC invites submissions describing the use and output of the new technology platforms used principally in the early stages of anti-infective drug discovery.  This category has been introduced to acknowledge the increased number of submissions of this type that complement more traditional approaches to drug discovery. Representative structures of agents identified using new technologies should be presented.

G. Adult and Pediatric Vaccine Studies and Pediatric Infections
Abstracts dealing with bacterial and viral vaccines to prevent infectious diseases are welcomed.  In addition, studies will be considered that address antigen discovery or delivery, new adjuvants or immunomodulators used to augment vaccine responses.  Both in vitro and in vivo data are acceptable.

G1. Bacterial, Viral and Other Vaccine Trials
G2. Antigen Discovery or Delivery and New Adjuvants or Immunomodulators to Augment Immune Responses
G3. Studies Relating to Aspects of Pediatric Infections, Including Therapy Trials

H. HIV/AIDS and Other Retroviruses, Including Resistance

Abstracts on most aspects of HIV, retroviruses and complications of AIDS are appropriate for this category. This category would include susceptibility testing methods and results, pathogenesis, epidemiology, natural history, pre-clinical studies of antiretroviral drugs (post-US IND), clinical trials, and outcomes research. The abstracts will be judged on uniqueness and clinical relevance of the studies. Treatment of opportunistic fungal and viral pathogens should be submitted to categories "M" and "V", respectively.

K. Nosocomial and Surgical Infections, and Clinical Epidemiology

In particular, the Program Committee welcomes abstracts dealing with studies that help us better understand the magnitude of the infection, risk factors, epidemiology, and prevention of endemic or epidemic infections in the Healthcare environment and in surgical patients. Also of interest are studies that have utilized molecular epidemiological techniques to address these issues. Studies that focus on molecular epidemiology of resistance bacteria, however, should be submitted to category "C2".

L.  Adult Community-Acquired Infections, Including Obstetrical-Gynecological and Sexually Transmitted Infections, and Clinical Trials of Therapy of Bacterial Infections

Abstracts on most aspects of community-acquired infections are appropriate for this category. This category would include studies of the natural history, epidemiology, prevention, treatment strategies, outcomes trials, and antibacterial clinical trials of community-acquired infections in adults; results of susceptibility testing of sexually transmitted pathogens are also appropriate.  In general, submission of an abstract based on a single case report is not encouraged

L1. Antibacterial Clinical Trials of Adults
L2. STD, Urinary Tract and ObB-Gyn Infections
L3. Other Studies of Adult Community-Acquired Infections

M. Mycology, Including Resistance and Mechanisms of Action of Antifungals

Abstracts on most aspects of medical mycology are appropriate for this category. This category would include diagnostic tools, susceptibility testing methods and results, mechanisms of action and resistance, pathogenesis, epidemiology, natural history, pre-clinical studies of antifungal drugs (post-US IND), and clinical trials. Due to the large number of abstracts received on antifungal susceptibility testing, priority is given to abstracts containing information on multi-center or multi-method comparison studies, new drugs, novel epidemiological aspects of resistance, and studies that investigate the technical aspects of susceptibility testing.

O. Pharmacoeconomics and Managed Care

The Program Committee encourages submission of abstracts dealing with pharmacoeconomics and managed care. Abstracts comparing costs or other advantages of different therapies or interventions should meet the abstract requirements listed for clinical trials (i.e., large number of patients, randomized design, and use of control drugs). The Program Committee is especially interested in abstracts dealing with new approaches in design, methodology, and evaluation of pharmacoeconomic studies and outcomes analysis.

P. Parasitology

Abstracts on most aspects of medical parasitology are appropriate for this category.  This category would include susceptibility testing methods and results, diagnostic tools, mechanisms of action and resistance, pathogenesis, epidemiology, and natural history.

V. Virology (Non-HIV), Including Resistance,  and Non-HIV Viral Opportunistic Infections in HIV-Infected Patients

Abstracts on most aspects of non-HIV virology are appropriate for this category. This category would include susceptibility testing methods and results, detection and rapid diagnostic methods, pathogenesis, epidemiology, natural history, pre-clinical studies of antiviral drugs (post-US IND), mechanisms of antiviral action and resistance, animal models, and clinical trials. The abstracts will be judged on uniqueness and clinical relevance of the studies.