Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
350 participants
INTERVENTIONAL
2014-04-28
2017-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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intensive monitoring
more intensive monitoring strategy of blood glucose and clinical review
intensive monitoring
standard monitoring
glucose monitoring followed the prevailing practice at each site
No interventions assigned to this group
Interventions
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intensive monitoring
Eligibility Criteria
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Inclusion Criteria
* diagnosed as having active pulmonary TB
* willing to join the study
Exclusion Criteria
* steroid-induced or gestational diabetes
18 Years
70 Years
ALL
No
Sponsors
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London School of Hygiene and Tropical Medicine
OTHER
Radboud University Medical Center
OTHER
Leiden University Medical Center
OTHER
University of Stellenbosch
OTHER
St George's, University of London
OTHER
University of Otago
OTHER
University of Medicine and Pharmacy Craiova
OTHER
University Medical Center Groningen
OTHER
Universidad Peruana Cayetano Heredia
OTHER
Universitas Padjadjaran
OTHER
Responsible Party
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Principal Investigators
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Hazel Dockrell, Prof
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Reinout van Crevel, MD, PhD
Role: STUDY_DIRECTOR
Radboud Universisty Nijmegen Medical Center
Locations
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Faculty of Medicine, Universitas Padjadjaran
Bandung, West Java, Indonesia
Universidad Peruana Cayetano Heredia
Lima, San Martin de Porres, Peru
University of Medicine and Pharmacy Craiova
Bucharest, , Romania
Countries
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References
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Baker MA, Harries AD, Jeon CY, Hart JE, Kapur A, Lonnroth K, Ottmani SE, Goonesekera SD, Murray MB. The impact of diabetes on tuberculosis treatment outcomes: a systematic review. BMC Med. 2011 Jul 1;9:81. doi: 10.1186/1741-7015-9-81.
Ruslami R, Aarnoutse RE, Alisjahbana B, van der Ven AJ, van Crevel R. Implications of the global increase of diabetes for tuberculosis control and patient care. Trop Med Int Health. 2010 Nov;15(11):1289-99. doi: 10.1111/j.1365-3156.2010.02625.x.
Bidstrup TB, Stilling N, Damkier P, Scharling B, Thomsen MS, Brosen K. Rifampicin seems to act as both an inducer and an inhibitor of the metabolism of repaglinide. Eur J Clin Pharmacol. 2004 Apr;60(2):109-14. doi: 10.1007/s00228-004-0746-z. Epub 2004 Mar 19.
Hatorp V, Hansen KT, Thomsen MS. Influence of drugs interacting with CYP3A4 on the pharmacokinetics, pharmacodynamics, and safety of the prandial glucose regulator repaglinide. J Clin Pharmacol. 2003 Jun;43(6):649-60.
Jaakkola T, Backman JT, Neuvonen M, Laitila J, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics of pioglitazone. Br J Clin Pharmacol. 2006 Jan;61(1):70-8. doi: 10.1111/j.1365-2125.2005.02515.x.
Niemi M, Backman JT, Neuvonen M, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of nateglinide in healthy subjects. Br J Clin Pharmacol. 2003 Oct;56(4):427-32. doi: 10.1046/j.1365-2125.2003.01884.x.
Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivisto KT. Rifampin decreases the plasma concentrations and effects of repaglinide. Clin Pharmacol Ther. 2000 Nov;68(5):495-500. doi: 10.1067/mcp.2000.111183.
Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivisto KT. Effects of rifampin on the pharmacokinetics and pharmacodynamics of glyburide and glipizide. Clin Pharmacol Ther. 2001 Jun;69(6):400-6. doi: 10.1067/mcp.2001.115822.
Niemi M, Kivisto KT, Backman JT, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of glimepiride. Br J Clin Pharmacol. 2000 Dec;50(6):591-5. doi: 10.1046/j.1365-2125.2000.00295.x.
Park JY, Kim KA, Kang MH, Kim SL, Shin JG. Effect of rifampin on the pharmacokinetics of rosiglitazone in healthy subjects. Clin Pharmacol Ther. 2004 Mar;75(3):157-62. doi: 10.1016/j.clpt.2003.10.003.
Park JY, Kim KA, Park PW, Park CW, Shin JG. Effect of rifampin on the pharmacokinetics and pharmacodynamics of gliclazide. Clin Pharmacol Ther. 2003 Oct;74(4):334-40. doi: 10.1016/S0009-9236(03)00221-2.
Syvalahti E, Pihlajamaki K, Iisalo E. Effect of tuberculostatic agents on the response of serum growth hormone and immunoreactive insulin to intravenous tolbutamide, and on the half-life of tolbutamide. Int J Clin Pharmacol Biopharm. 1976 Mar;13(2):83-9.
Zilly W, Breimer DD, Richter E. Induction of drug metabolism in man after rifampicin treatment measured by increased hexobarbital and tolbutamide clearance. Eur J Clin Pharmacol. 1975 Dec 19;9(2-3):219-27. doi: 10.1007/BF00614021.
Related Links
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official website of TANDEM project
Other Identifiers
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TB-201403.01
Identifier Type: -
Identifier Source: org_study_id
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