RESEARCH TEAM

  • Lisa Anderson, RN, BSN
  • Dorothy Chaney
  • Curtisha Charles
  • Mindy Clevenger
  • Leonardo Diaz
  • Denise Jones
  • Robert A. Jurao, RN, BSN
  • Johan Melendez, MS
  • Diane Osiecki, MBA
  • Barbara Wilgus, MSN, CRNP

Office:
(410) 550-9080

Email: idresearch@jhmi.edu

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Research

The Infectious Diseases Research Team at Johns Hopkins Bayview is a team of physicians, nurses, coordinators, assistants and laboratory personnel from diverse backgrounds and clinical experiences. The health and well-being of our research subjects is our top priority. We work collaboratively with our physicians and hospital staff to ensure the safety of all participants in our clinical trials.

Our Government and Industry sponsored clinical trials program participates in national and international clinical trials of new therapies for infectious diseases. We are a phase one clinical trial site for the National Institutes of Health (NIH), Division of Microbiology and Infectious Diseases (DMID).

We are recruiting healthy volunteers and persons with specific infectious conditions.

If you are healthy, between the ages of 18–45 and would like to participate, please contact one of our study coordinators.


We are currently recruiting for the following active studies:

 

KRN23 Drug Study for Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome

A Phase 2 open-label trial to assess the efficacy and safety of KRN23, an antibody to FGF23, in subjects with tumor-induced osteomalacia (TIO) or epidermal nevus syndrome (ENS), (UX023T-CL201)

The purpose of this research study is to study the safety and effectiveness of the investigational drug, KRN23, in the treatment of adults 18 years of age and older with Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS). Patients with TIO and ENS have either tumors or skin growths that produce high levels of a protein called FGF23. High FGF23 levels prevent people from reabsorbing phosphorus into their kidneys, which can lead to bone abnormalities, fractures, bone and muscle pain, and muscle weakness. The study drug, KRN23, binds to and inhibits FGF23.

The word “investigational” means that KRN23 is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of KRN23 in this study.

KRN23 has been studied previously in adults with X-Linked Hypophosphatemia (XLH). Patients with TIO and ENS are similar to patients with XLH in that their bodies cannot keep normal levels of phosphorus in their blood, which leads to different types of bone defects such as osteomalacia. Patients with XLH, TIO and ENS have high levels of FGF23. The goal of this study is to see whether KRN23 can help patients keep normal levels of phosphorus in their blood and improve their clinical condition.

People with tumor-induced osteomalacia (TIO) or epidermal nevus syndrome (ENS) and who have a tumor or skin lesion that cannot be completely removed by surgery may join.

Contact:
Leonardo Diaz
ldiaz18@jhmi.edu
(410) 550-9080

Principal Investigator:
Suzanne Jan De Beur, MD

 

KRN23 Drug Study for X-linked Hypophosphatemia

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of KRN23 in Adults with X-linked Hypophosphatemia (XLH), UX023-CL303

This research is being done to study the safety and effectiveness of the investigational drug KRN23 in the treatment of adults aged 18 to 65 years with X linked hypophosphatemia (XLH).

The word “investigational” means that KRN23 is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of KRN23 in this study.

KRN23 may improve the level of phosphate that the body uses in the formation of bones.

In this randomized, double-blind, placebo-controlled study, subjects will either receive repeated monthly doses of KRN23 or placebo until Week 24. A placebo is an inactive material that does not contain any active study drug. Double-blind means that you, your doctor, nurse and other site staff will not know if you are taking KRN23 or placebo. After Week 24, research subjects who received placebo during the first 24 weeks will begin receiving KRN23 every 4 weeks and will no longer receive placebo. This means that after week 24 all research subjects in the study will be receiving KRN23 every 4 weeks. During this part of the study, both you and your doctor will know that you are receiving KRN23.

Contact:
Leonardo Diaz
ldiaz18@jhmi.edu
(410) 550-9080

Principal Investigator:
Suzanne Jan De Beur, MD

 

Telavancin Drug Study

A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects with Staphylococcus aureus Bacteremia Including Infective Endocarditis

This research is being done to compare the use of the drug telavancin with standard of care intravenous therapy in the treatment of people with the blood infection Staphylococcus aureus bacteremia.

Telavancin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated skin and skin structure infections and hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus (S. aureus). Telavancin is not FDA approved for the treatment of S. aureus bacteremia and therefore its use in this study is investigational. The FDA is allowing the use of telavancin in this study.

Infections caused by a type of bacteria called a “Gram-positive pathogen” may cause serious and life-threatening diseases in both healthy patients and patients who are already sick. A problem with treating infections caused by these bacteria is that some of the bacteria no longer respond to the current treatments. The development of a new drug that would be effective in treating infections caused by these bacteria is important, and would give doctors another drug to use.

Contact:
Robert A. Jurao, RN, BS
rojurao@jhmi.edu
(410) 550-9080

Lisa Anderson, RN, BSN
lknight5@jhmi.edu
410) 550-9080

Leonardo Diaz
ldiaz18@jhmi.edu
(410) 550-9080

Principal Investigator:
Seema Nayak, MD

 

Staph Vaccine Trial

A phase 2b, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a Staphylococcus aureus 4- antigen vaccine (SA4Ag) in adults undergoing elective posterior instrumented lumbar spinal fusion procedures (B3451002)

This research is being done to learn whether vaccination with SA4Ag, given 10 to 60 days before surgery, as compared to placebo can help prevent infections after surgery caused by staph. A placebo is a substance that looks like the study drug but that contains no active ingredients. The use of SA4Ag in this research study is investigational. The word “investigational” means that SA4Ag is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of SA4Ag in this study.

Skin is the body’s natural barrier to infection. When the skin is opened for surgery, it is possible for bacteria (germs) to enter the wound and cause an infection. Occasionally these germs also enter the bloodstream. These sorts of infections are known as surgical site and bloodstream infections. About 1 to 3 people in every 100 develop a surgical site infection after spinal surgery while bloodstream infections are much less common. The most common germs found in these infections is Staphylococcus aureus, also known as S. aureus, staph, staph aureus, MRSA, MSSA or golden staph.

Pfizer has developed an investigational vaccine (SA4Ag) to help prevent infections caused by staph. When given to humans, SA4Ag causes the body’s immune system to make antibodies (germ fighting proteins), which may have the potential to recognize and kill staph germs that enter the body through the cut in the skin made during surgery.

To obtain this information, we will closely monitor participants for signs of infection for 6 months after their surgery. In addition, we will gather information on the side effects of SA4Ag and participants’ general health.

People who plan to undergo an elective lumbar fusion (spinal surgery) procedure in the next few weeks may join.

A description of this study can be found at www.clinicaltrials.gov

Contact:
Robert A. Jurao, RN, BSN
rojurao@jhmi.edu
(410) 550-9080

Lisa Anderson, RN, BSN
lknight5@jhmi.edu
410) 550-9080

Principal Investigator
Geeta Sood, MD

 

Skin Microbiome Study

Understanding the Skin Microbiome Through the Integration of Metagenomics, Bioinformatics, Spatial Ecology, and Synthetic Biology

This research is being done to gather information and learn more about the function of skin microbial ecosystems. For this, we will conduct fine-scale sampling of the human skin microbiome and collect information regarding environmental and behavioral variables that might influence skin microbial composition.

In addition, we seek methods for ‘remote sensing’ of the skin microbiome. To achieve this, we will require GC/MS data that can then be correlated with the types of microbes in a person’s microbiome.

Contact:
Leonardo Diaz
ldiaz18@jhmi.edu
(410) 550-9080

Mindy Clevenger
Mcleven1@jhmi.edu
(410) 550-9080

Curtisha Charles
ccharle8@jhmi.edu
(410) 550-9080

Denice Jones
djones7@jhmi.edu
(410) 550-9080

Principal Investigator
Seema Nayak, MD

 

Solithromycin Phase III

Vaginal Mucous Collection Study