Adjunctive rosiglitazone treatment for severe pediatric malaria : A randomized placebo-controlled trial in Mozambican children
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved..
OBJECTIVES: We tested the hypothesis that adjunctive rosiglitazone treatment would reduce levels of circulating angiopoietin-2 (Angpt-2) and improve outcomes of Mozambican children with severe malaria.
METHODS: A randomized, double-blind, placebo-controlled trial of rosiglitazone vs placebo as adjunctive treatment to artesunate in children with severe malaria was conducted. A 0.045 mg/kg/dose of rosiglitazone or matching placebo were administered, in addition to standard of malaria care, twice a day for 4 days. The primary endpoint was the rate of decline of Angpt-2 over 96 hours. Secondary outcomes included the longitudinal dynamics of angiopoietin-1 (Angpt-1) and the Angpt-2/Angpt-1 ratio over 96 hours, parasite clearance kinetics, clinical outcomes, and safety metrics.
RESULTS: Overall, 180 children were enrolled; 91 were assigned to rosiglitazone and 89 to placebo. Children who received rosiglitazone had a steeper rate of decline of Angpt-2 over the first 96 hours of hospitalization compared to children who received placebo; however, the trend was not significant (P = 0.28). A similar non-significant trend was observed for Angpt-1 (P = 0.65) and the Angpt-2/Angpt-1 ratio (P = 0.34). All other secondary and safety outcomes were similar between groups (P >0.05).
CONCLUSION: Adjunctive rosiglitazone at this dosage was safe and well tolerated but did not significantly affect the longitudinal kinetics of circulating Angpt-2.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:139 |
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| Enthalten in: |
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases - 139(2024) vom: 15. Jan., Seite 34-40 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Varo, Rosauro [VerfasserIn] |
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| Links: |
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| Themen: |
05V02F2KDG |
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| Anmerkungen: |
Date Completed 15.01.2024 Date Revised 15.01.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.ijid.2023.11.031 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365043346 |
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| 100 | 1 | |a Varo, Rosauro |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Adjunctive rosiglitazone treatment for severe pediatric malaria |b A randomized placebo-controlled trial in Mozambican children |
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| 500 | |a Date Revised 15.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a OBJECTIVES: We tested the hypothesis that adjunctive rosiglitazone treatment would reduce levels of circulating angiopoietin-2 (Angpt-2) and improve outcomes of Mozambican children with severe malaria | ||
| 520 | |a METHODS: A randomized, double-blind, placebo-controlled trial of rosiglitazone vs placebo as adjunctive treatment to artesunate in children with severe malaria was conducted. A 0.045 mg/kg/dose of rosiglitazone or matching placebo were administered, in addition to standard of malaria care, twice a day for 4 days. The primary endpoint was the rate of decline of Angpt-2 over 96 hours. Secondary outcomes included the longitudinal dynamics of angiopoietin-1 (Angpt-1) and the Angpt-2/Angpt-1 ratio over 96 hours, parasite clearance kinetics, clinical outcomes, and safety metrics | ||
| 520 | |a RESULTS: Overall, 180 children were enrolled; 91 were assigned to rosiglitazone and 89 to placebo. Children who received rosiglitazone had a steeper rate of decline of Angpt-2 over the first 96 hours of hospitalization compared to children who received placebo; however, the trend was not significant (P = 0.28). A similar non-significant trend was observed for Angpt-1 (P = 0.65) and the Angpt-2/Angpt-1 ratio (P = 0.34). All other secondary and safety outcomes were similar between groups (P >0.05) | ||
| 520 | |a CONCLUSION: Adjunctive rosiglitazone at this dosage was safe and well tolerated but did not significantly affect the longitudinal kinetics of circulating Angpt-2 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 650 | 4 | |a Adjunctive | |
| 650 | 4 | |a Angiopoietin | |
| 650 | 4 | |a Malaria | |
| 650 | 4 | |a Plasmodium falciparum | |
| 650 | 4 | |a Rosiglitazone | |
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| 700 | 1 | |a Sitoe, Antonio |e verfasserin |4 aut | |
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| 700 | 1 | |a Vitorino, Pio |e verfasserin |4 aut | |
| 700 | 1 | |a Mucasse, Campos |e verfasserin |4 aut | |
| 700 | 1 | |a Valente, Marta |e verfasserin |4 aut | |
| 700 | 1 | |a Ajanovic, Sara |e verfasserin |4 aut | |
| 700 | 1 | |a Balanza, Núria |e verfasserin |4 aut | |
| 700 | 1 | |a Zhong, Kathleen |e verfasserin |4 aut | |
| 700 | 1 | |a Derpsch, Yiovanna |e verfasserin |4 aut | |
| 700 | 1 | |a Gladstone, Melissa |e verfasserin |4 aut | |
| 700 | 1 | |a Mayor, Alfredo |e verfasserin |4 aut | |
| 700 | 1 | |a Bassat, Quique |e verfasserin |4 aut | |
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