Publication: An open label randomized controlled trial of tamoxifen combined with amphotericin B and Fluconazole for cryptococcal meningitis
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Issued Date
2021-09-01
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ISSN
2050084X
Other identifier(s)
2-s2.0-85116894834
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Mahidol University
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SCOPUS
Bibliographic Citation
eLife. Vol.10, (2021)
Suggested Citation
Nguyen Thi Thuy Ngan, Nhat Thanh Hoang Le, Nguyen Ngo Vi Vi, Ninh Thi Thanh Van, Nguyen Thi Hoang Mai, Duong Van Anh, Phan Hai Trieu, Nguyen Phu Huong Lan, Nguyen Hoan Phu, Nguyen van Vinh Chau, David G. Lalloo, William Hope, Justin Beardsley, Nicholas J. White, Ronald Geskus, Guy E. Thwaites, Damian Krysan, Luong Thi Hue Tai, Evelyne Kestelyn, Tran Quang Binh, Le Quoc Hung, Nguyen Le Nhu Tung, Jeremy N. Day An open label randomized controlled trial of tamoxifen combined with amphotericin B and Fluconazole for cryptococcal meningitis. eLife. Vol.10, (2021). doi:10.7554/eLife.68929 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/76034
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Title
An open label randomized controlled trial of tamoxifen combined with amphotericin B and Fluconazole for cryptococcal meningitis
Author(s)
Nguyen Thi Thuy Ngan
Nhat Thanh Hoang Le
Nguyen Ngo Vi Vi
Ninh Thi Thanh Van
Nguyen Thi Hoang Mai
Duong Van Anh
Phan Hai Trieu
Nguyen Phu Huong Lan
Nguyen Hoan Phu
Nguyen van Vinh Chau
David G. Lalloo
William Hope
Justin Beardsley
Nicholas J. White
Ronald Geskus
Guy E. Thwaites
Damian Krysan
Luong Thi Hue Tai
Evelyne Kestelyn
Tran Quang Binh
Le Quoc Hung
Nguyen Le Nhu Tung
Jeremy N. Day
Nhat Thanh Hoang Le
Nguyen Ngo Vi Vi
Ninh Thi Thanh Van
Nguyen Thi Hoang Mai
Duong Van Anh
Phan Hai Trieu
Nguyen Phu Huong Lan
Nguyen Hoan Phu
Nguyen van Vinh Chau
David G. Lalloo
William Hope
Justin Beardsley
Nicholas J. White
Ronald Geskus
Guy E. Thwaites
Damian Krysan
Luong Thi Hue Tai
Evelyne Kestelyn
Tran Quang Binh
Le Quoc Hung
Nguyen Le Nhu Tung
Jeremy N. Day
Other Contributor(s)
Faculty of Tropical Medicine, Mahidol University
Oxford University Clinical Research Unit
Cho Ray Hospital
University College London Hospitals NHS Foundation Trust
Liverpool School of Tropical Medicine
University of Liverpool
Faculty of Medicine and Health
University of Iowa Carver College of Medicine
Nuffield Department of Medicine
The Westmead Institute for Medical Research
Oxford University Clinical Research Unit
Cho Ray Hospital
University College London Hospitals NHS Foundation Trust
Liverpool School of Tropical Medicine
University of Liverpool
Faculty of Medicine and Health
University of Iowa Carver College of Medicine
Nuffield Department of Medicine
The Westmead Institute for Medical Research
Abstract
Background: Cryptococcal meningitis has high mortality. Flucytosine is a key treatment but is expensive and rarely available. The anti-cancer agent tamoxifen has synergistic anti-cryptococcal activity with amphotericin in vitro. It is off-patent, cheap, and widely available. We performed a trial to determine its therapeutic potential. Methods: Open label randomized controlled trial. Participants received standard care - amphotericin combined with fluconazole for the first two weeks - or standard care plus tamoxifen 300mg/day. The primary end point was Early Fungicidal Activity (EFA) - the rate of yeast clearance from cerebrospinal fluid (CSF). Trial registration https://clinicaltrials.gov/ct2/show/NCT03112031. Results: 50 patients were enrolled, (median age 34 years, 35 male). Tamoxifen had no effect on EFA (- 0.48log10 colony-forming units/mL/CSF control arm versus -0.49 tamoxifen arm, difference - 0.005log10CFU/ml/day, 95%CI: -0.16, 0.15, P=0.95). Tamoxifen caused QTc prolongation. Conclusion: High dose tamoxifen does not increase the clearance rate of Cryptococcus from CSF. Novel, affordable therapies are needed.