Welcome to the BAMBU/BAMSG web site!

What is the BAMSG?

The Bacteriology and Mycology Study Group (BAMSG) is a national clinical research group sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The group was established in 1978 as the Mycoses Study Group to provide a clinical trials infrastructure to identify key unanswered questions in the treatment of serious fungal infections. The group is composed of leading clinical scientists who help to establish research priorities based on public health needs and scientific opportunities and advances. As of the year 2000, the framework was expanded to include the study of resistant bacterial infections in the hospital setting and the name of the group was changed to the Bacteriology and Mycology Study Group.

The BAMSG Central Unit is located at the University of Alabama at Birmingham and is overseen by Dr. Peter Pappas, the BAMSG Principal Investigator (PI). The PI is responsible for the overall performance of BAMSG clinical trials and leads the Steering Committee, which develops and guides overall BAMSG policy and determines the BAMSG research agenda priorities and activities.

Focus:

A nationwide network of research centers conduct trials in the areas of bacterial and fungal infections. The BAMSG focuses its efforts on 4 high-risk populations. These risk groups comprise:

Risk Group 1: Cancer or organ transplantation patients who are immunocompromised as a result of receiving chemotherapy or immunosuppression.

Risk Group 2: Patients who are not immunocompromised but at risk for serious fungal infections, including very low birthweight babies and hospitalized adults.

Risk Group 3: HIV-infected individuals at risk for fungal infections.

Risk Group 4: Hospitalized patients, especially those in the intensive care unit (ICU), who are at risk for resistant bacterial infections.

Each of the 4 Risk Groups is chaired by an experienced and established investigator with expertise relating to his/her specific risk group population. The Risk Group Chair works with a research committee consisting of site investigators and representatives of collaborating groups who generate concepts and protocols, identify new areas for research and comment on concepts and protocols being developed by other members of the group.

The BAMSG conducts a variety of types of studies, which include:

Specific organisms of interest to the BAMSG include:

Fungi

Opportunistic Pathogens:

Primary Pathogens:

Resistant Bacteria

Role of BAMBU

The Bacteriology and Mycology Biostatistical and Operations Unit (BAMBU) is located at Rho, Inc. in Chapel Hill, North Carolina. The Principal Investigator is Dr. Dennis Wallace and the Co-Principal Investigator is Dr. Ronald W. Helms.

BAMBU supports the BAMSG through:

Current Multi-center Projects

BAMSG 3-01

A phase II randomized trial of amphotericin B alone or combined with fluconazole in the treatment of AIDS-associated cryptococcal meningitis

This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will look at whether study participants recover more quickly and have fewer side effects if they are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as compared to the standard treatment. Participants will be followed for approximately 6 months from the time they are enrolled into the study.

BAMSG 4-01

Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial

This study will determine if rates of colonization and infection with 2 resistant Gram positive bacteria—methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE)—among patients in adult intensive care units (ICUs) are lower in ICUs that use an intensive infection control strategy plus standard care compared to ICUs that use standard care alone. The intensive control strategy involves: 1) identifying patients who are colonized with MRSA or VRE by reporting the results of surveillance cultures of the anterior nares and stool or perianal area; 2) Universal Gloving (use of gloves during interactions with the patient or the patient’s environment) until the patients are discharged or their surveillance culture results show they are not colonized with MRSA or VRE (whichever happens first); and 3) Contact Precautions (use of gloves and gowns during interactions with the patient or the patient’s environment) during care of patients who are colonized with MRSA or VRE. Standard care involves proper hand hygiene (handwashing or use of a waterless hand antiseptic) and use of Standard Precautions (use of gloves and other barriers as needed for interactions involving contact with mucous membranes, wounds, and body fluids) and collection of surveillance cultures, but not reporting of results to these sites. The surveillance cultures will be performed by obtaining swabs of the nose and stool or perianal area from patients upon admission to the ICU, at weekly intervals thereafter, and upon discharge from the ICU. The results of the surveillance cultures will be used to compare the rate of colonization with MRSA and VRE in ICUs using the intensive control strategy with those that use standard care alone.

BAMSG 4-02

Randomized, Multi-Center, Comparative Trial of Short-Course Empiric Antibiotic Therapy versus Standard Antibiotic Therapy for Subjects with Pulmonary Infiltrates in the Intensive Care Unit (ICU): Impact on Antimicrobial Resistance, Superinfections, Length of ICU Stay and Hospitalization, and Mortality

This study will enroll subjects who have been hospitalized at least three days (on or after fourth day of the hospital stay), who have new pulmonary infiltrates during their ICU stay and who are at low risk of having pneumonia, as determined using the Clinical Pulmonary Infection Score (CPIS). The study is designed to determine whether 3 days of antibiotic treatment with meropenem (with or without coverage for MRSA) can reduce the risk of colonization with antimicrobial-resistant bacteria or the isolation of a potential pathogen compared to a standard antibiotic therapy (minimum of 8 days of therapy with antibiotics of the primary care team’s choosing). The study will also examine whether short-course therapy reduces length of ICU and hospital LOS and costs based on ICU and hospital LOS, antibiotic treatment, and standardized costs related to the treatment of infection-related adverse experiences, without having a negative effect on subject mortality or the incidence of clinically significant infection.

BAMSG 4-03

Derivation of a Clinical Prediction Rule for Bacterial Pulmonary Infection in Mechanically Ventilated Children

This study will develop a scoring system to allow doctors to accurately identify children on a mechanical ventilator who have bacterial pneumonia. Currently this diagnosis is very difficult to make, resulting in the overuse of antibiotics and the promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four ICUs at 3 children’s hospitals will participate. Children greater than 48 weeks post-conception and less than 18 years old who require mechanical ventilation, and in whom the bedside caregivers suspect bacterial pneumonia, will be studied. Clinical information will be collected at the time that antibiotics are started and again 3 days later. Bacteria will be quantified by sampling lung fluid through the breathing tube less than 6 hours of starting antibiotics, using a procedure known as “non-bronchoscopic-bronchoalveolar lavage (NB-BAL).” The validity of the clinical data, alone and in combination, in predicting which children have high concentrations of bacteria in their lungs, will be tested statistically.