Kelly Dooley, MD

Role:

Faculty

Associate Professor of Medicine, Pharmacology, and Molecular Sciences

Dr. Dooley is an Associate Professor of Medicine, Pharmacology, and Molecular Sciences at Johns Hopkins University School of Medicine, with appointments in the Divisions of Clinical Pharmacology and Infectious Diseases. She is also a faculty member at the Center for Clinical Global Health Education.

Dr. Dooley has an HIV outpatient practice and attends on the inpatient HIV service. Her research focuses on tuberculosis therapeutics with an emphasis on Phase I or II clinical trials of new or existing TB drugs and treatment of HIV/TB co-infection. She is Principal Investigator or Protocol Chair for several clinical trials involving TB drugs for drug-sensitive TB or drug-resistant TB and involved in the scientific committees of the Tuberculosis Trials Consortium, AIDS Clinical Trials Group, and IMPAACT networks. She has a special interest in optimizing TB drugs for special populations, including children and pregnant women.>

Dr. Dooley received her MD from Duke University, and completed residency training in internal medicine and an infectious diseases fellowship at Johns Hopkins School of Medicine. She is board certified in internal medicine and infectious diseases.

Studies/Projects
Publications

Pharmacokinetic Assessment of MDR-TB Drugs in the Treatment of TB Meningitis

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2020-08-23

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Hinduja Hospital

Rationale: MDR-TBM is a devastating disease with high mortality and severe neurologic sequelae among survivors. We recognize the importance of sufficient drug concentrations at the site of infection for efficacy of anti-TB drugs and believe it is likely that drug distribution into brain and CSF...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

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2019-08-19

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Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

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2019-08-19

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Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB...

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB

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2018-06-07

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New study will characterize the pharmacokinetics of delamanid using a model-based approach, and evaluate safety and tolerability of over 24 weeks of study treatment in HIV infected and uninfected children.

Optimizing Treatment to Improve TBM Outcomes in Children: Substudy on Clinical Profile and CSF Biorepository of the Pediatric Suspected Meningitis Cases

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2017-07-18

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This sub-study is being led by PIs Dr. Kelly Dooley and Dr. Chhaya Valvi. Meningoencephalitis is associated with significant morbidity and mortality. Several viruses, bacteria, and fungal pathogens including Neisseria meningitidis, Streptococcus pneumoniae, Mycobacterium...

MDR-TB Free: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy

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2017-03-24

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Hinduja Hospital

This study is also known as MDR-TB MUKT: Monitoring Adverse Effects, Utilizing Resources Optimally, Knowing Resistance Patterns, and Treatment Strategy. Purpose: To establish an observational cohort of MDR-TB cases and household contacts with accompanying biorepository at PD Hinduja National...

Measuring TB Drugs in Hair as a Tool to Monitor Adherence, Exposure and Response in Patients with HIV

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2016-08-16

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Our study will examine whether hair levels of two key first line tuberculosis drugs will be useful markers to identify individuals at highest risk of treatment failure in active tuberculosis. Our study aims to provide a lowcost clinical tool using hair that can be noninvasively...

Optimizing Treatment to Improve TBM Outcomes in Children

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2014-05-01

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This study, known as TBM Kids, is being conducted in India and Malawi. Primary Objectives To characterize the pharmacokinetics (PK) (plasma and cerebrospinal fluid (CSF)) of rifampicin given at model-derived optimal daily doses and...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

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2007-02-02

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Comprising clinical trial sites at Johns Hopkins Medicine in Baltimore, Whitman Walker Health in Washington, DC, and the BJGMC-CCGHE collaboration in Pune, India, the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU) is one of only 25 international HIV/TB clinical trial sites funded by the...

Sex Differences in TB Clinical Presentation, Drug Exposure, and Treatment Outcomes in India

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2023-04-01

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CHEST

Background: The role of sex differences in clinical presentation, TB drug pharmacokinetic variables, and treatment outcomes is unclear. Research question: What is the effect of sex on TB disease severity, drug exposure, and treatment outcome? Study design and methods: This study was a prospective...

Randomized Clinical Trial of High Dose Rifampicin with or without Levofloxacin versus Standard of Care for Paediatric Tuberculous Meningitis: The TBM-KIDS Trial

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2022-10-29

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Clinical Infectious Diseases

Background Pediatric tuberculous meningitis (TBM) commonly causes death or disability. In adults, high-dose rifampicin may reduce mortality. The role of fluoroquinolones remains unclear. There have been no antimicrobial treatment trials for pediatric TBM. Methods TBM-KIDS was a phase 2 open-label...

Pharmacokinetics and Safety of 3 Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women

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2022-06-01

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Clinical Infectious Diseases

Background Pregnancy increases the risk of tuberculosis and its complications. A 3-month regimen of weekly isoniazid and rifapentine (3HP) is safe and effective for tuberculosis prevention in adults and children, including those with HIV, but 3HP has not been evaluated in pregnancy. Methods IMPAACT...

Performance of Xpert MTB/RIF and Xpert Ultra for the diagnosis of tuberculous meningitis among Indian children

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2022-04-01

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International Journal of Tuberulosis and Lung Disease

OBJECTIVE: To assess Xpert® MTB/RIF (Xpert) and Xpert® MTB/RIF Ultra (Ultra) performance in diagnosing pediatric tuberculous meningitis (TBM). METHODS: We conducted a study among children with suspected meningoencephalitis in Pune, India. Clinical, radiological, laboratory, and treatment data were...

Pharmacokinetics and Safety of Three Months of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Pregnant Women

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2022-03-05

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Clinical Infectious Diseases

Background Pregnancy increases the risk of tuberculosis and its complications. A 3-month regimen of weekly isoniazid and rifapentine (3HP) is safe and effective for tuberculosis prevention in adults and children, including those with HIV, but 3HP has not been evaluated in pregnancy. Methods IMPAACT...

Diabetes Mellitus and Tuberculosis Treatment Outcomes in Pune, India

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2021-04-01

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Open Forum Infectious Diseases

Background Diabetes mellitus (DM) increases the risk of tuberculosis (TB) disease. Knowledge of the impact of DM on TB treatment outcomes is primarily based on retrospective studies. Methods We conducted a prospective cohort study of new pulmonary TB patients with and without DM (TB-DM and TB only...

Measuring TB drug levels in the hair in adults and children to monitor drug exposure and outcomes

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2021-01-01

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International Journal of Tuberculosis and Lung Disease

INTRODUCTION: Testing for anti-TB drugs in small hair samples may serve as a non-invasive tool to measure cumulative drug exposure and/or adherence, as these determine treatment success. We aimed to assess how well hair assays of TB drugs predict TB treatment outcomes.METHODS: A small thatch of...

Drug resistant TB spine in a two year old child: A case report

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2020-07-14

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Indian Journal of Tuberculosis

Spinal tuberculosis (TB) is a disease of high morbidity that is associated with deformity and neurological sequelae, especially in growing children. Children diagnosed with spinal TB need to be monitored closely for clinical improvements. Previous history of antituberculous therapy (ATT), poor...

Mullen Scales of Early Learning Adaptation for Assessment of Indian Children and Application to Tuberculous Meningitis

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2020-07-04

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Journal of Tropical Pediatrics

Introduction: Tuberculous meningitis (TBM) results in significant morbidity and mortality among children worldwide. Associated neurocognitive complications are common but not well characterized. The Mullen Scales of Early Learning (MSEL), a well-established measure for assessment of...

Once-Weekly Rifapentine and Isoniazid (3HP) Among Patients with HIV Taking Dolutegravir-based Antiretroviral Therapy: A Phase I/II Clinical Trial

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2020-06-01

Publication:

The Lancet HIV

Background Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV. However, a small previous trial of such therapy with dolutegravir in healthy, HIV-...

Once-weekly Rifapentine and Isoniazid for Tuberculosis Prevention in Patients With HIV Taking Dolutegravir-Based Antiretroviral Therapy: A Phase 1/2 Trial

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2020-03-30

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Lancet HIV

Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV.

Isoniazid Preventive Therapy and Pregnancy Outcomes in Women Living With Human Immunodeficiency Virus in the Tshepiso Cohort

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2019-10-21

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Clinical Infectious Disease

Background Both pregnancy and human immunodeficiency virus (HIV) increase the risk of tuberculosis disease, which results in poor maternal, pregnancy, and infant outcomes. Isoniazid preventive therapy (IPT) reduces mortality among individuals living with HIV in high-burden settings but has recently...

Challenges in conducting trials for pediatric tuberculosis meningitis: lessons learned in the field

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2019-10-01

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International Journal of Tuberculosis and Lung Disease

International Journal of Tuberculosis and Lung Disease: Researchers describe the challenges associated with conducting the first randomized clinical trial of antimicrobial agents in pediatric tuberculosis meningitis.

Delamanid central nervous system pharmacokinetics in tuberculous meningitis in rabbits and humans

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2019-09-23

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Hinduja Hospital

Publication:

Antimicrobial Agents and Chemotherapy

Central nervous system tuberculosis (TB) is devastating and affects vulnerable populations. Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculous meningitis (TBM) specifically are nearly uniformly fatal, with little information being available to guide the treatment of...

Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology

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2019-07-15

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PLoS Medicine

Summary points Translational and clinical pharmacology are the state-of-the-art tools used by drug developers to efficiently move compounds and regimens through all drug development phases. Tuberculosis drug and regimen development, though, has traditionally underutilized these modern, model-based...

Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology

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2019-07-05

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PLOS

Application of clinical pharmacology best practices is essential to the efficient and rational development of drugs. In general, knowledge gained about exposure–response relationships in preclinical models aids drug and dose selection in human studies, and biomarkers and pharmacokinetic (PK) data...

Subtherapeutic rifampicin concentration is associated with unfavourable tuberculosis treatment outcomes

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2019-05-10

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Clinical Infectious Diseases

Rifampicin concentrations were sub-therapeutic in most Indian patients taking a thrice-weekly TB regimen

The global landscape of tuberculosis therapeutics

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2018-11-07

Publication:

Annual Review of Medicine

Abstract Tuberculosis (TB) is one of the oldest infections afflicting humans yet remains the number one infectious disease killer worldwide. Despite decades of experience treating this disease, TB regimens require months of multidrug therapy, even for latent infections...

The effect of diabetes mellitus on the pharmacokinetics and pharmacodynamics of tuberculosis treatment

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2018-08-20

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Antimicrobial Agents and Chemotherapy

DM and higher HbA1c increased the risk of not achieving therapeutic targets for pyrazinamide, but higher pyrazinamide concentrations were asociated with worse microbiologic and clinical outcomes

Challenges of TB and co-treatment: updates and insights

Post Date:

2018-08-04

Publication:

Current Opinion in HIV and AIDS

PURPOSE OF REVIEW: In the past few years, tuberculosis (TB) has overtaken HIV as the infectious disease with the highest global mortality. Successful management of this syndemic will require improved diagnostic tests, shorter preventive therapies, and more effective treatments,...

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