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Active, Not Recruiting

NCT Number: NCT05149157

Trajectories and Mechanisms of Recovery From Malaria: An Observational Study

This observational research study aims to answer the question: 'Which aspects of human biology play an important role in recovery from symptomatic malaria?'

In particular, the researchers aim to identify human genes for which the level of gene activity reflects the patient's overall rate of recovery. The researchers believe this approach may reveal new targets for adjunctive therapies.

The researchers aim to recruit 240 people, of all ages, who have been diagnosed with symptomatic malaria at selected hospitals in London. Blood samples, urine samples, and clinical information will be collected over the 14 days following malaria diagnosis.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

8 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film.

Exclusion criteria

Patients with asymptomatic malaria; Patients with congenital malaria; Patients with Plasmodium gametocytaemia only; Patients with known HIV; Patients who have received antimalarial treatment for symptomatic malaria in the 28 days prior to hospital presentation; Patients who explicitly deny consent.

Treatment and study plan

Symptomatic malaria

Other

This observational study will be recruiting patients who have symptomatic malaria (confirmed by presence of asexual stage parasitaemia of any Plasmodium species on blood film)

Primary outcomes

  1. Genes for which expression (level of gene activity) correlates with a 'composite recovery score'

    Time frame: Each study participant will be assessed over the 14 days following malaria diagnosis

    The 'composite recovery score' will be calculated by principal component analysis of rates of recovery for individual markers of tissue, organ, or organ system dysfunction, and extraction of the value of the first principal component for each participant. Genes for which expression correlates with the 'composite recovery score' will be identified by whole blood transcriptome analysis.

Secondary outcomes

  1. Genes for which expression (level of gene activity) correlates with rate of recovery for individual markers of tissue, organ, or organ system dysfunction

    Time frame: Each study participant will be assessed over the 14 days following malaria diagnosis

    Genes for which expression correlates with the individual markers of tissue, organ, or organ system dysfunction will be identified by whole blood transcriptome analysis.

  2. Rate of recovery for individual markers of tissue, organ, or organ system dysfunction

    Time frame: Each study participant will be assessed over the 14 days following malaria diagnosis

    Rates of recovery will be calculated for individual markers of tissue, organ, or organ system dysfunction

  3. Sequences of clinical events predictive of recovery, as determined by Bayesian inference of dynamic pathways using the HyperTraPS statistical platform

    Time frame: Each study participant will be assessed over the 14 days following malaria diagnosis

    Hypercubic transition path sampling (HyperTraPS) will be used to characterise patterns of recovery and identify predictors of fast vs slow recovery

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Search for Correlates of Recovery in the Patient Transcriptome (SCRIPT) (Malaria) Study

Acronym: SCRIPT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2021
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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