Evidence map›Paper›PMID 39219856›Full record

ArticleWellcome open research2023

SEVUparin as a potential Adjunctive Treatment in children with severe malaria: A phase I trial safety and dose finding trial (SEVUSMAART).

Kathryn Maitland, Mainga Hamaluba, Nchafatso Obonyo, Emmanuel Oguda, Christabel Mogoka, Thomas N Williams, Mike Chaponda, Sam Miti, Luc Kambale Kamavu, Jonathan Jonathan Gwasupika and 8 more

Abstract read
In one paragraph

Article in Wellcome open research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Malaria: past, present, and future.Signal transduction and targeted therapy · 2025
    Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Kathryn MaitlandDepartment of Infectious Disease and Institute of Global Health and Innovation, Imperial College London, London, England, UK.ORCID https://orcid.org/0000-0002-1862-8109
Mainga HamalubaClinical Research, 1. KEMRI-Wellcome Trust Research Programme, Kilifi, Kilifi, Po Box 230, Kenya.ORCID https://orcid.org/0000-0002-0266-1414
Nchafatso ObonyoClinical Research, 1. KEMRI-Wellcome Trust Research Programme, Kilifi, Kilifi, Po Box 230, Kenya.ORCID https://orcid.org/0000-0002-5040-4359
Emmanuel OgudaClinical Research, 1. KEMRI-Wellcome Trust Research Programme, Kilifi, Kilifi, Po Box 230, Kenya.
Christabel MogokaClinical Research, 1. KEMRI-Wellcome Trust Research Programme, Kilifi, Kilifi, Po Box 230, Kenya.
Thomas N WilliamsDepartment of Infectious Disease and Institute of Global Health and Innovation, Imperial College London, London, England, UK.ORCID https://orcid.org/0000-0003-4456-2382
Mike ChapondaTropical Diseases Research Centre, Ndola, P.O Box 71769, Zambia.
Sam MitiTropical Diseases Research Centre, Ndola, P.O Box 71769, Zambia.
Luc Kambale KamavuSt. Pauls' Mission Hospital, Nchelenge, Luapula Province, Zambia.
Jonathan Jonathan GwasupikaTropical Diseases Research Centre, Ndola, P.O Box 71769, Zambia.ORCID https://orcid.org/0000-0001-9007-2304
Roisin ConnonMedical Research Council Clinical Trials, University College London, London, England, WC1V 6LJ, UK.ORCID https://orcid.org/0000-0002-4408-4336
Diana M GibbMedical Research Council Clinical Trials, University College London, London, England, WC1V 6LJ, UK.ORCID https://orcid.org/0000-0002-9738-5490
Arjen DondorpClinical Trials, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, 10400, Thailand.ORCID https://orcid.org/0000-0001-5190-2395
Nick DayClinical Trials, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, 10400, Thailand.ORCID https://orcid.org/0000-0003-2309-1171
Nick WhiteClinical Trials, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, 10400, Thailand.ORCID https://orcid.org/0000-0002-1897-1978
A Sarah WalkerMedical Research Council Clinical Trials, University College London, London, England, WC1V 6LJ, UK.
Elizabeth C GeorgeMedical Research Council Clinical Trials, University College London, London, England, WC1V 6LJ, UK.
Severe Malaria in African Children A Research and Trials (SMAART) consortium

Funding

Wellcome Trust
6 · The paper itself

Abstract

Background: Even on the best antimalarial treatments (injectable artesunate) African children with severe malaria have poor outcomes with most deaths occurring early in the course of hospital admission (<24hours). Lactic acidosis, largely due to impairment of the microcirculatory flow due to parasite sequestration, is a main risk factor for poor outcome. There are no adjuvant treatments for severe malaria that target this complication. Sevuparin, a heparin-like drug, binds to Methods: A Phase I trial designed to provide data on safety, dosing, feasibility of sevuparin as an adjuvant therapy in Kenya and Zambian children with severe malaria complicated by lactic acidosis (> 2mmol/l). Three intravenous doses will be given at admission (0 hours), 8 and 16 hours. APPT will be measured 1 hour after each dose (to assess maximum toxicity). Studying 20 children will allow sufficient data on safety to be generated across a range of doses to identify the maximum tolerated dose (MTD) using the Continual Reassessment Method, which adapts or informs subsequent doses for each child based on the data from previously enrolled children. The MTD will be identified based on the dose-toxicity model updated by each previous patient's APTT results using standard methods. Conclusions: The results of the Phase I trial will identify the final dose to be tested in a Phase II trial in terms of both efficacy and safety outcomes. Registration: PACTR number: 202007890194806 (date 20/07/2020) ISRCTN32271864 (date 28/07/2021).

Indexed as

adjunctive therapyAfricachildrenclinical trialheparin-like moleculesevere malaria

Identifiers

PMID39219856
PMCPMC11362743

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.