Clinical Pharmacology

The OUCRU Clinical Pharmacology department is based in Ho Chi Minh City. We specialize in the bioanalysis of anti-infective drugs in a variety of biological fluids such as blood, plasma, urine or cerebrospinal fluid. A variety of sample preparation techniques (such as solid-phase extraction, liquid-liquid extraction) are combined with High Performance Liquid Chromatography (HPLC) methodologies to quantify drugs from human matrices. All assays are developed, validated and conducted in accordance with international guidelines standards.

 

The importance of clinical pharmacology in Viet Nam

Many drugs are used to treat infectious diseases at HTD and other hospitals throughout the country. To optimize drug regimens (dose and frequency of drug administration), our department aims to describe how the body interacts with the drug (Pharmacokinetics or PK) but also what is the effect of the drug on the body (Pharmacodynamics or PD). By understanding the PK/PD relationships, the clinical pharmacology department can help clinicians to identifying treatment failures and propose enhanced therapies. Our main areas of research are designed to meet the needs of patients and clinical personnel responsible for patient care.

 

Our clinical pharmacology researchers

The Pharmacology laboratory was first implemented by Thomas Pouplin in 2008. In October 2011, he relocated his scientific activities to the Department of Clinical Pharmacology at MORU, in Bangkok, Thailand. Pham Van Toi is now responsible for the clinical pharmacology laboratory at OUCRU. He receives the help of Pham Nguyen Phuong who has been a Research Assistant since 2011.

 

What we’re doing to improve outcomes for patients

Sometimes, existing therapies can be less effective or more toxic in the population, for example in sub-groups of patients such as children. Our department helps clinicians to get better therapies in these vulnerable populations. The clinical pharmacology department participates in the design of experimental studies and is responsible for the sample collection and for the quantification of drug levels in the clinical samples (e.g. blood, plasma, CSF). Our findings and conclusions will provide an improved understanding of how drugs can better cure patients and save lives. We aim to enhance the existing therapies and make them available and affordable for Vietnamese patients.

 

What we’re doing to understand clinical pharmacology better

Dengue shock syndrome (DSS). Dextran solution clearance study in Dengue patients versus healthy volunteers to evaluate the alteration of the glycocalyx layer responsible for the vascular leakage in DSS.

Pharmacokinetic evaluation of oral valacyclovir as a substitute to intravenous acyclovir in the treatment of Herpes simplex encephalitis (HSE). Oral valacyclovir was shown to be an equivalent but cheaper alternative in the treatment of HSE.

Tuberculous Meningitis (TBM) in children. Pharmacokinetics/Pharmacodynamics (PK/PD) relationships of the first line antituberculous drugs in plasma and cerebrospinal fluid (CSF) of children with TBM. Our PK/PD models are expected to propose a revised regimen adapted to children with TBM. A new paediatric regimen can then be proposed and experimented in Vietnam.

Standard versus Intensified drug regimen in adults with TBM/HIV. PK/PD relationships in plasma and CSF and drug/drug interaction study. We aim to provide a better understanding of the drug exposure in plasma and CSF of patients with TBM. Our findings could change the recommended treatment of TBM at a national and international level.

Investigation of the P.vivax resistance to chloroquine. Chloroquine is still the first line treatment of P.vivax in Viet Nam, however, the late parasitological failure (LPF) by day 28 was found in the infected patients treated with chloroquine. Pharmacokinetic investigation would confirm and characterise the true resistance of P.vivax to chloroquine and may contribute to shaping the treatment policy in control malaria in the country.

Therapeutic Drug Monitoring-TDM. Monitoring drug concentrations in the treatment (TDM-Therapeutic Drug Monitoring), is generally considered the quantification and interpretation of drug concentrations measurements, to the individualisation of drug therapy on patients in hospitals. The purpose of TDM is to optimize patients’ outcome by monitoring drugs concentration and optimizing the dose/response. In collaboration with our partnership-Hospital for Tropical Diseases (HTD) HCM City, we aim to prepare and set up TDM service for antibiotics (vancomycin) used to treat patients with severe infections in some focused wards of HTD.

 

Our clinical pharmacology research locations

  • Hospital for Tropical Diseases in HCMC (laboratory and PK room for healthy volunteer studies)
  • Pham Ngoc Thach Hospital for TB and Lung Diseases (main hospital for TB project)
  • Phuoc Long hospital and Bu Gia Map HealthCare Station in Binh Phuoc Province (Malaria Project)

 

Our clinical pharmacology research collaborations/partnerships

  • Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok, Thailand
  • University of Medicine and Pharmacy of Ho Chi Minh City, Vietnam

 

Key milestones in our clinical pharmacology research

The clinical pharmacology department works and receives valuable support from the Clinical Pharmacology Department in MORU-BKK for the PK and PK/PD modelling of anti-tuberculosis and anti-malarial drugs in Vietnamese patients.

2007: Pharmacokinetics of artemisinin in healthy Vietnamese male volunteers

2009: Dextran clearance study in Vietnamese Dengue patients and healthy volunteers

2010: HPLC Method for Quantification of acyclovir in plasma and CSF samples from Herpes Simplex Virus Patients

2011: Identification of beta-lactam antibiotics in urine samples from paediatric patients

2012: HPLC Method for Measurement of Levofloxacin in plasma and CSF samples from Adult TBM patients

2013: Bioanalytical Method for Quantification of Chloroquine and its metabolite in plasma and whole blood samples from P.vivax Patients

 

Publications

Nguyen-Pouplin J, Pouplin T, Van TP, The TD, Thi DN, Farrar J, et al. Dextran Fractional Clearance Studies in Acute Dengue Infection. PLoS Negl Trop Dis. 2011 Aug;5(8):e1282. doi: 10.1371/journal.pntd.0001282. Epub 2011 Aug 23. PMID: 21886850

Pouplin T, Pouplin JN, Van Toi P, Lindegardh N, Rogier van Doorn H, Hien TT, et al. Valacyclovir for Herpes Simplex Encephalitis. Antimicrob Agents Chemother. 2011 Jul;55(7):3624-6. doi: 10.1128/AAC.01023-10. Epub 2011 May 16. PMID: 21576427

Hien TT, Hanpithakpong W, Truong NT, Dung NT, Toi PV, Farrar J, et al. Orally formulated artemisinin in healthy fasting Vietnamese male subjects: a randomized, four-sequence, open-label, pharmacokinetic crossover study. Clin Ther. 2011 May;33(5):644-54. doi: 10.1016/j.clinthera.2011.04.017. PMID: 21665048

Lindegardh N, Tarning J, Toi PV, Hien TT, Farrar J, Singhasivanon P, et al. Quantification of artemisinin in human plasma using liquid chromatography coupled to tandem mass spectrometry. J Pharm Biomed Anal. 2009 Apr 5;49(3):768-73. doi: 10.1016/j.jpba.2008.12.014. Epub 2008 Dec 24. PMID: 19162422

Heemskerk D, Day J, Chau TT, Dung NH, Yen NT, Bang ND, et al. Intensified treatment with high dose rifampicin and levofloxacin compared to standard treatment for adult patients with tuberculous meningitis (TBM-IT): protocol for a randomized controlled trial. Trials. 2011 Feb 2;12:25. doi: 10.1186/1745-6215-12-25. PMID: 21288325