Kelly Dooley, MD

Role: 
Faculty
Associate Professor of Medicine, Pharmacology, and Molecular Sciences
Kelly Dooley, MD

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.

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

Post Date: 
2019-08-19
   |   
Countries: 
   |   
Clinical Sites: 
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 patients living with HIV compared with TB...

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

Post Date: 
2019-08-19
   |   
Countries: 
   |   
Clinical Sites: 
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 patients living with HIV compared with 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

Post Date: 
2018-06-07
   |   
Countries: 
   |   
Clinical Sites: 
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

Post Date: 
2017-07-18
   |   
Countries: 
   |   
Clinical Sites: 
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 tuberculosis, Herpes...

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

Post Date: 
2017-03-24
   |   
Countries: 
   |   
Clinical Sites: 
This study is also known as MDR-TB MUKT: M onitoring Adverse Effects, U tilizing Resources Optimally, K nowing Resistance Patterns, and T reatment 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

Post Date: 
2016-08-16
   |   
Countries: 
   |   
Clinical Sites: 
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 collected to monitor...

TBM Kids Substudy: Assessment of Neurocognitive Functions in Children with Tuberculosis Meningitis and Healthy Control Children Using the Mullen Scale of Early Learning Attending a Tertiary Care Public Hospital in Pune, India

Post Date: 
2014-09-01
   |   
Countries: 
   |   
Clinical Sites: 
Objectives: The aim of the present study is to examine the neurological deficit in TBM kids and for that we need to assess, feasibility of the MSEL in our set up an Indian population of healthy children and children with meningitis in particular TB meningitis(TBM). The primary objective of the...

Optimizing Treatment to Improve TBM Outcomes in Children

Post Date: 
2014-05-01
   |   
Countries: 
   |   
Clinical Sites: 
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 levofloxacin in children ages 6 months to 12 years of age with TBM...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date: 
2007-02-02
   |   
Countries: 
   |   
Clinical Sites: 
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...

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

Post Date: 
2020-07-04
   |   
Countries: 
Publication: 
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 for Tuberculosis Prevention in Patients With HIV Taking Dolutegravir-Based Antiretroviral Therapy: A Phase 1/2 Trial

Post Date: 
2020-03-30
Publication: 
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.

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

Post Date: 
2019-10-01
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
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

Post Date: 
2019-09-23
   |   
Clinical Sites: 
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

Post Date: 
2019-07-15
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
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

Post Date: 
2019-07-05
   |   
Countries: 
Publication: 
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

Post Date: 
2019-05-10
   |   
Countries: 
Publication: 
Clinical Infectious Diseases
Rifampicin concentrations were sub-therapeutic in most Indian patients taking a thrice-weekly TB regimen

The global landscape of tuberculosis therapeutics

Post Date: 
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

Post Date: 
2018-08-20
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
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,...

The global neurological burden of tuberculosis

Post Date: 
2018-05-18
Publication: 
Seminars in Neurology
Central nervous system (CNS) involvement of tuberculosis (TB) is the most severe manifestation of TB and accounts for approximately 5 to 10% of all extrapulmonary TB (EPTB) cases and approximately 1% of all TB cases. TB meningitis (TBM) is the most common form of CNS TB, though other forms...

Suboptimal antituberculosis drug concentrations and outcomes in small and HIV‐coinfected children in India: Recommendations for dose modifications

Post Date: 
2017-12-16
   |   
Countries: 
Publication: 
Clinical Pharmacology and Therapeutics
This work aimed to evaluate the once-daily antituberculosis treatment as recommended by the new Indian pediatric guidelines. Isoniazid, rifampin, and pyrazinamide concentration-time profiles and treatment outcome were obtained from 161 Indian children with drug-sensitive tuberculosis...

Isoniazid concentrations in hair and plasma area-under-the-curve exposure among children with tuberculosis

Post Date: 
2017-12-07
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
PLOS One
PLOS One: Mave and colleagues compared TB drug exposure in plasma and hair samples among a small cohort of children.

Suboptimal anti-tuberculosis drug concentrations and outcomes in small and HIV coinfected children in India: recommendations for dose modifications

Post Date: 
2017-12-01
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
Clinical Pharmacology and Therapeutics
This work aimed to evaluate the once-daily anti-tuberculosis treatment as recommended by the new Indian pediatric guidelines. Isoniazid, rifampin and pyrazinamide concentration-time profiles and treatment outcome were obtained from 161 Indian children with drug-sensitive tuberculosis...

The epidemiology, pathogenesis, transmission, diagnosis, and management of multidrug-resistant, extensively drug-resistant, and incurable tuberculosis

Post Date: 
2017-03-24
Publication: 
The Lancet Respiratory Medicine
Global tuberculosis incidence has declined marginally over the past decade, and tuberculosis remains out of control in several parts of the world including Africa and Asia. Although tuberculosis control has been effective in some regions of the world, these gains are threatened by the increasing...

Tuberculosis associated with HIV infection

Post Date: 
2017-01-15
Publication: 
Microbiology Spectrum
Abstract Tuberculosis (TB) has recently surpassed HIV as the primary infectious disease killer worldwide, but the two diseases continue to display lethal synergy. The burden of TB is disproportionately borne by people living with HIV, particularly where HIV and poverty...

Bedaquiline

Post Date: 
2017-01-01
Publication: 
Kucers’ the Use of Antibiotics: A Clinical Review of Antibacterial, Antifungal, and Antiviral Drugs, 7th Edition
Section II, Antibiotics: Part 12 Anti-tuberculosis drugs.

Isoniazid hair concentrations in children with tuberculosis: a proof of concept study

Post Date: 
2016-06-01
   |   
Countries: 
   |   
Clinical Sites: 
Publication: 
International Journal of Tuberculosis and Lung Disease
Assessing treatment adherence and quantifying exposure to anti-tuberculosis drugs among children is challenging. We undertook a 'proof of concept' study to assess the drug concentrations of isoniazid (INH) in hair as a therapeutic drug monitoring tool. Children aged <12 years initiated on...

Toward earlier inclusion of pregnant and postpartum women in TB drug trials: consensus statements from an International Expert Panel

Post Date: 
2016-01-04
Publication: 
Clinical Infectious Diseases
Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15–44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and...

Pediatric tuberculous meningitis: model-based approach to determining optimal doses of anti-tuberculosis drugs for children

Post Date: 
2015-10-22
   |      |   
Clinical Sites: 
Publication: 
Clinical Pharmacology and Therapeutics
Pediatric tuberculous meningitis (TBM) is a highly morbid, often fatal disease. Standard treatment includes isoniazid, rifampin, pyrazinamide, and ethambutol. Current rifampin dosing achieves low cerebrospinal fluid (CSF) concentrations, and CSF penetration of ethambutol is poor. In adult...

Pages

Rifapentine pharmacokinetics and safety in pregnant women with and without HIV on 3HP

Post Date: 
2020-03-11
   |   
Countries: 
Mathad JS , Savic RM, Britto P, Wiesner L, Townley E, Chakhtoura N, Bradford S, Patil S, Vhembo T, Lespinasse D, Langat D, Werarak P, Kamthunzi P, Gupta A, Dooley KE. Rifapentine pharmacokinetics and safety in pregnant women with and without HIV on 3HP. Presented at: CROI 2020. Boston, MA; March 8-...

Early bactericidal activity of meropenem (+ Amox/Clav) with and without rifampin for TB

Post Date: 
2020-03-10
   |   
Countries: 
De Jager V, Abufathi AA, Feyt H, Gupte N, Vanker N, Barnes G, van Brakel E, Nuermberger E, Dorman SE, Svensson EM, Diacon AH, Dooley KE. Early bactericidal activity of meropenem (+ Amox/Clav) with and without rifampin for TB. Presented at: CROI 2020. Boston, Massachusetts. March 8-11, 2020.

Effect of rifamycins on pretomanid exposure in patients with pulmonary TB

Post Date: 
2020-03-10
   |   
Countries: 
Abdelwahab MT , Ignatius E, Denti P, Dooley KE, Gupte N, Dawson R, Barnes G, Narunsky K, Hendricks B. Effect of rifamycins on pretomanid exposure in patients with pulmonary TB. (ID 3688). Presented at: CROI 2020. Boston, Massachusetts. March 8-11, 2020.

Why pharmacokinetics/pharmacodynamics of TB medicines matter in the management of MDR-TB

Post Date: 
2019-10-30
Dooley K . Why pharmacokinetics/pharmacodynamics of TB medicines matter in the management of MDR-TB. Lecture. 50th Union World Conference on Lung Health. Hyderabad, India. October 30-November 2, 2019.

What Is the Right Dose of Pyrazinamide?

Post Date: 
2018-10-25
Dooley K. What Is the Right Dose of Pyrazinamide? Symposium: Optimisation of Standard Drugs in the Treatment of Tuberculosis, Finally?

Pharmacokinetics/pharmacodynamics of tuberculosis medicines: outcomes of a WHO expert consultation

Post Date: 
2018-10-24
Dooley K. Pharmacokinetics/pharmacodynamics of tuberculosis medicines: outcomes of a WHO expert consultation. Post graduate course: Update on Clinical and Programmatic Management of Multi-drug- and Extensively Drug-resisant MB (MDR/XDR-TB). 49th Annual Union World Conference on Lung Health. The...

Pharmacokinetics, pharmacodynamics (PK/PD) and Critical Concentrations of Tuberculosis Medicines

Post Date: 
2018-10-24
Dooley K, Gilpin C. Pharmacokinetics, pharmacodynamics (PK/PD) and Critical Concentrations of Tuberculosis Medicines. Workshop: Updated World Health Organization Policies on the Management of Tuberculosis. 49th Annual Union World Conference on Lung Health. The Hague, The Netherlands. October 24-27...

Sub-Therapeutic Concentrations of Anti-Tuberculosis Drugs in Children when Treated According to Indian Dosing Recommendation

Post Date: 
2016-10-24
   |   
Countries: 
   |   
Clinical Sites: 
Guiastrennec B, Ramachandran G, Karlsson MO, Kumar H, Bhavani PK, Gangadevi NP, Swaminathan S, Gupta A, Dooley KE, Savic RM. Sub-Therapeutic Concentrations of Anti-Tuberculosis Drugs in Children when Treated According to Indian Dosing Recommendation. 9th Annual International Workshop on Clinical...

Isoniazid Hair Concentrations in Children with TB

Post Date: 
2015-12-05
   |   
Countries: 
   |   
Clinical Sites: 
Mave V, Kinikar AA, Gupte N, Nimkar S, Kagal A, Horng H, Ramachandran G, Dooley K, Gupta A. Isoniazid Hair Concentrations in Children with TB. 46th Union World Conference on Lung Health. International Union for Tuberculosis and Lung Disease. Cape Town, South Africa.

TB/HIV Treatment during Pregnancy: Does Drug Metabolism Change?

Post Date: 
2015-12-04
Dooley K, Savic R. TB/HIV Treatment during Pregnancy: Does Drug Metabolism Change? The 46th Union World Conference on Lung Health. Cape Town, South Africa.