Prospective evaluation of improving fluoroquinolone exposure using centralised therapeutic drug monitoring (TDM) in patients with tuberculosis (PERFECT): a study protocol of a prospective multicentre cohort study

被引：6

作者：

van den Elsen, Simone H. J. ^{[1
]}

Sturkenboom, Marieke G. G. ^{[1
]}

Akkerman, Onno ^{[2
,3
]}

Barkane, Linda ^{[4
]}

Bruchfeld, Judith ^{[5
,6
]}

Eather, Geoffrey ^{[7
,8
]}

Heysell, Scott K. ^{[9
]}

Hurevich, Henadz ^{[10
]}

Kuksa, Liga ^{[4
]}

Kunst, Heinke ^{[11
]}

Kuhlin, Johanna ^{[5
,6
]}

Manika, Katerina ^{[12
]}

Moschos, Charalampos ^{[13
]}

Mpagama, Stellah G. ^{[14
]}

Munoz Torrico, Marcela ^{[15
]}

Skrahina, Alena ^{[10
]}

Sotgiu, Giovanni ^{[16
]}

Tadolini, Marina ^{[17
]}

Tiberi, Simon ^{[18
]}

Volpato, Francesca ^{[17
]}

van der Werf, Tjip S. ^{[2
,19
]}

Wilson, Malcolm R. ^{[7
,8
]}

Zuniga, Joaquin ^{[20
,21
]}

Touw, Daan J. ^{[1
]}

Migliori, Giovanni B. ^{[22
]}

Alffenaar, Jan-Willem ^{[1
,23
]}

机构：

[1] Univ Groningen, Univ Med Ctr Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands

[2] Univ Groningen, Univ Med Ctr Groningen, Dept Pulm Dis & TB, Groningen, Netherlands

[3] Univ Groningen, Univ Med Ctr Groningen, TB Ctr Beatrixoord, Haren, Netherlands

[4] Riga East Univ Hosp, TB & Lung Dis Clin, Dept Multidrug Resistant TB, Riga, Latvia

[5] Karolinska Inst, Dept Med, Div Infect Dis, Stockholm, Sweden

[6] Karolinska Univ Hosp, Dept Infect Dis, Stockholm, Sweden

[7] Princess Alexandra Hosp, Dept Resp Med, Woolloongabba, Qld, Australia

[8] Princess Alexandra Hosp, Metro South Clin TB Serv, Woolloongabba, Qld, Australia

[9] Univ Virginia, Div Infect Dis & Int Hlth, Charlottesville, VA USA

[10] Republican Sci & Pract Ctr Pulmonol & TB, Minsk, BELARUS

[11] Queen Mary Univ London, Barts Hlth NHS Trust, Blizard Inst, Dept Resp Med, London, England

[12] Aristotle Univ Thessaloniki, G Papanikolaou Hosp, Resp Infect Unit, Pulm Dept, Thessaloniki, Greece

[13] Sotiria Hosp Chest Dis, Drug Resistant TB Unit, Athens, Greece

[14] Kibongoto Infect Dis Hosp, Kilimanjaro, Tanzania

[15] Inst Nacl Enfermedades Resp, Clin TB, Mexico City, DF, Mexico

[16] Univ Sassari, Dept Med Surg & Expt Sci, Clin Epidemiol & Med Stat Unit, Sassari, Italy

[17] Univ Bologna, Alma Mater Studiorum, Unit Infect Dis, Dept Med & Surg Sci, Bologna, Italy

[18] Queen Mary Univ London, Blizard Inst, Dept Infect, Barts Hlth NHS Trust, London, England

[19] Univ Groningen, Univ Med Ctr Groningen, Dept Internal Med, Groningen, Netherlands

[20] Inst Nacl Enfermedades Resp, Lab Immunobiol & Genet, Mexico City, DF, Mexico

[21] Tecnol Monterrey, Escuela Med & Ciencias Salud, Mexico City, DF, Mexico

[22] Ist Clin Sci Maugeri IRCCS, Serv Epidemiol Clin Malattie Resp, Tradate, Italy

[23] Univ Sydney, Fac Med & Hlth, Sydney Pharm Sch, Sydney, NSW, Australia

来源：

BMJ OPEN | 2020年 / 10卷 / 06期

关键词：

tuberculosis; clinical pharmacology; organisation of health services; infectious diseases; MULTIDRUG-RESISTANT TUBERCULOSIS; ARTIFICIAL-INTELLIGENCE; TB; MOXIFLOXACIN; MANAGEMENT; REGIMENS; OUTCOMES;

D O I：

10.1136/bmjopen-2019-035350

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

IntroductionGlobal multidrug-resistant tuberculosis (MDR-TB) treatment success rates remain suboptimal. Highly active WHO group A drugs moxifloxacin and levofloxacin show intraindividual and interindividual pharmacokinetic variability which can cause low drug exposure. Therefore, therapeutic drug monitoring (TDM) of fluoroquinolones is recommended to personalise the drug dosage, aiming to prevent the development of drug resistance and optimise treatment. However, TDM is considered laborious and expensive, and the clinical benefit in MDR-TB has not been extensively studied. This observational multicentre study aims to determine the feasibility of centralised TDM and to investigate the impact of fluoroquinolone TDM on sputum conversion rates in patients with MDR-TB compared with historical controls.Methods and analysisPatients aged 18 years or older with sputum smear and culture-positive pulmonary MDR-TB will be eligible for inclusion. Patients receiving TDM using a limited sampling strategy (t=0and t=5hours) will be matched to historical controls without TDM in a 1:2 ratio. Sample analysis and dosing advice will be performed in a centralised laboratory. Centralised TDM will be considered feasible if >80% of the dosing recommendations are returned within 7days after sampling and 100% within 14 days. The number of patients who are sputum smear and culture-negative after 2months of treatment will be determined in the prospective TDM group and will be compared with the control group without TDM to determine the impact of TDM.Ethics and disseminationEthical clearance was obtained by the ethical review committees of the 10 participating hospitals according to local procedures or is pending (online supplementary file 1). Patients will be included after obtaining written informed consent. We aim to publish the study results in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT03409315).

引用

页数：7

共 49 条

[41] Highly successful treatment outcome of multidrug-resistant tuberculosis in the Netherlands, 2000-2009 [J].

van Altena, R. ;

de Vries, G. ;

Haar, C. H. ;

de Lange, W. C. M. ;

Magis-Escurra, C. ;

van den Hof, S. ;

van Soolingen, D. ;

Boeree, M. J. ;

van der Werf, T. S. .

INTERNATIONAL JOURNAL OF TUBERCULOSIS AND LUNG DISEASE, 2015, 19 (04) :406-412

[42] Limited Sampling Strategies Using Linear Regression and the Bayesian Approach for Therapeutic Drug Monitoring of Moxifloxacin in Tuberculosis Patients [J].

van den Elsen, Simone H. J. ;

Sturkenboom, Marieke G. G. ;

Akkerman, Onno W. ;

Manika, Katerina ;

Kioumis, Ioannis P. ;

van der Werf, Tjip S. ;

Johnson, John L. ;

Peloquin, Charles ;

Touw, Daan J. ;

Alffenaar, Jan-Willem C. .

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2019, 63 (07)

[43] Population Pharmacokinetic Model and Limited Sampling Strategies for Personalized Dosing of Levofloxacin in Tuberculosis Patients [J].

van den Elsen, Simone H. J. ;

Sturkenboom, Marieke G. G. ;

van't Boveneind-Vrubleuskaya, Natasha ;

Skrahina, Alena ;

van der Werf, Tjip S. ;

Heysell, Scott K. ;

Mpagama, Stellah ;

Migliori, Giovanni B. ;

Peloquin, Charles A. ;

Touw, Daan J. ;

Alffenaar, Jan-Willem C. .

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2018, 62 (12)

[44] End TB with precision treatment! [J].

van der Burgt, Evelien P. M. ;

Sturkenboom, Marieke G. G. ;

Bolhuis, Mathieu S. ;

Akkerman, Onno W. ;

Kosterink, Jos G. W. ;

de Lange, Wiel C. M. ;

Cobelens, Frank G. J. ;

van der Werf, Tjip S. ;

Alffenaar, Jan-Willem C. .

EUROPEAN RESPIRATORY JOURNAL, 2016, 47 (02) :680-682

[45]

van't Boveneind-Vrubleuskaya N, 2017, ANTIMICROB AGENTS CH, V61, DOI [10.1128/AAC.00343-17, 10.1128/aac.00343-17]

[46]

World Health Organization, 2023, Call for experts

[47]

World Health Organization, 2018, Rapid communication: key changes to treatment of multidrugand rifampicin-resistant tuberculosis (MDR/RR-TB)

[48] Urine colorimetry for therapeutic drug monitoring of pyrazinamide during tuberculosis treatment [J].

Zentner, Isaac ;

Modongo, Chawangwa ;

Zetola, Nicola M. ;

Pasipanodya, Jotam G. ;

Srivastava, Shashikant ;

Heysell, Scott K. ;

Mpagama, Stellah ;

Schlect, Hans P. ;

Gumbo, Tawanda ;

Bisson, Gregory P. ;

Vinnard, Christopher .

INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, 2018, 68 :18-23

[49] Current status and opportunities for therapeutic drug monitoring in the treatment of tuberculosis [J].

Zuur, Marlanka A. ;

Bolhuis, Mathieu S. ;

Anthony, Richard ;

den Hertog, Alice ;

van der Laan, Tridia ;

Wilffert, Bob ;

de Lange, Wiel ;

van Soolingen, Dick ;

Alffenaar, Jan-Willem C. .

EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY, 2016, 12 (05) :509-521

← 1 2 3 4 5 →