Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial.
<h4>Background</h4>Thrombocytopenia, bleeding and plasma leakage are major complications of dengue. Activation of endogenous sialidases with desialylation of platelets and endothelial cells may underlie these complications. We aimed to assess the effects of the neuraminidase inhibitor os...
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2022-01-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0010051&type=printable |
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| author | Rahajeng N Tunjungputri Silvita Fitri Riswari Setyo G Pramudo Lydia Kuntjoro Bachti Alisjahbana Harry Galuh Nugraha Andre van der Ven Muhammad Hussein Gasem Quirijn de Mast |
| author_facet | Rahajeng N Tunjungputri Silvita Fitri Riswari Setyo G Pramudo Lydia Kuntjoro Bachti Alisjahbana Harry Galuh Nugraha Andre van der Ven Muhammad Hussein Gasem Quirijn de Mast |
| author_sort | Rahajeng N Tunjungputri |
| collection | DOAJ |
| description | <h4>Background</h4>Thrombocytopenia, bleeding and plasma leakage are major complications of dengue. Activation of endogenous sialidases with desialylation of platelets and endothelial cells may underlie these complications. We aimed to assess the effects of the neuraminidase inhibitor oseltamivir on platelet recovery and plasma leakage in dengue.<h4>Methods</h4>We performed a phase 2, double-blind, multicenter, randomized trial in adult dengue patients with thrombocytopenia (<70,000/μl) and a duration of illness ≤ 6 days. Oseltamivir phosphate 75mg BID or placebo were given for a maximum of five days. Primary outcomes were the time to platelet recovery (≥ 100,000/μl) or discharge from hospital and the course of measures of plasma leakage.<h4>Results</h4>A total of 70 patients were enrolled; the primary outcome could be assessed in 64 patients (31 oseltamivir; 33 placebo). Time to platelet count ≥100,000/μl (n = 55) or discharge (n = 9) were similar in the oseltamivir and placebo group (3.0 days [95% confidence interval, 2.7 to 3.3] vs. 2.9 days [2.5 to 3.3], P = 0.055). The kinetics of platelet count and parameters of plasma leakage (gall bladder thickness, hematocrit, plasma albumin, syndecan-1) were also similar between the groups.<h4>Discussion</h4>In this trial, adjunctive therapy with oseltamivir phosphate had no effect on platelet recovery or plasma leakage parameters.<h4>Trial registration</h4>ISRCTN35227717. |
| format | Article |
| id | doaj-art-e4398df282324fd78179779de42013f0 |
| institution | DOAJ |
| issn | 1935-2727 1935-2735 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Neglected Tropical Diseases |
| spelling | doaj-art-e4398df282324fd78179779de42013f02025-08-20T02:46:28ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352022-01-01161e001005110.1371/journal.pntd.0010051Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial.Rahajeng N TunjungputriSilvita Fitri RiswariSetyo G PramudoLydia KuntjoroBachti AlisjahbanaHarry Galuh NugrahaAndre van der VenMuhammad Hussein GasemQuirijn de Mast<h4>Background</h4>Thrombocytopenia, bleeding and plasma leakage are major complications of dengue. Activation of endogenous sialidases with desialylation of platelets and endothelial cells may underlie these complications. We aimed to assess the effects of the neuraminidase inhibitor oseltamivir on platelet recovery and plasma leakage in dengue.<h4>Methods</h4>We performed a phase 2, double-blind, multicenter, randomized trial in adult dengue patients with thrombocytopenia (<70,000/μl) and a duration of illness ≤ 6 days. Oseltamivir phosphate 75mg BID or placebo were given for a maximum of five days. Primary outcomes were the time to platelet recovery (≥ 100,000/μl) or discharge from hospital and the course of measures of plasma leakage.<h4>Results</h4>A total of 70 patients were enrolled; the primary outcome could be assessed in 64 patients (31 oseltamivir; 33 placebo). Time to platelet count ≥100,000/μl (n = 55) or discharge (n = 9) were similar in the oseltamivir and placebo group (3.0 days [95% confidence interval, 2.7 to 3.3] vs. 2.9 days [2.5 to 3.3], P = 0.055). The kinetics of platelet count and parameters of plasma leakage (gall bladder thickness, hematocrit, plasma albumin, syndecan-1) were also similar between the groups.<h4>Discussion</h4>In this trial, adjunctive therapy with oseltamivir phosphate had no effect on platelet recovery or plasma leakage parameters.<h4>Trial registration</h4>ISRCTN35227717.https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0010051&type=printable |
| spellingShingle | Rahajeng N Tunjungputri Silvita Fitri Riswari Setyo G Pramudo Lydia Kuntjoro Bachti Alisjahbana Harry Galuh Nugraha Andre van der Ven Muhammad Hussein Gasem Quirijn de Mast Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial. PLoS Neglected Tropical Diseases |
| title | Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial. |
| title_full | Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial. |
| title_fullStr | Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial. |
| title_full_unstemmed | Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial. |
| title_short | Effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia; a phase 2, multicenter, double-blind, randomized trial. |
| title_sort | effect of oseltamivir phosphate versus placebo on platelet recovery and plasma leakage in adults with dengue and thrombocytopenia a phase 2 multicenter double blind randomized trial |
| url | https://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0010051&type=printable |
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