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Trajectories and Mechanisms of Recovery From Malaria: An Observational Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05149157
Acronym
SCRIPT
Enrollment
240
Registered
2021-12-08
Start date
2022-08-02
Completion date
2026-01-05
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Malaria, Recovery, Transcriptomics

Brief summary

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.

Interventions

OTHERSymptomatic malaria

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)

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Days to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Genes for which expression (level of gene activity) correlates with a 'composite recovery score'Each study participant will be assessed over the 14 days following malaria diagnosisThe '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

MeasureTime frameDescription
Genes for which expression (level of gene activity) correlates with rate of recovery for individual markers of tissue, organ, or organ system dysfunctionEach study participant will be assessed over the 14 days following malaria diagnosisGenes for which expression correlates with the individual markers of tissue, organ, or organ system dysfunction will be identified by whole blood transcriptome analysis.
Rate of recovery for individual markers of tissue, organ, or organ system dysfunctionEach study participant will be assessed over the 14 days following malaria diagnosisRates of recovery will be calculated for individual markers of tissue, organ, or organ system dysfunction
Sequences of clinical events predictive of recovery, as determined by Bayesian inference of dynamic pathways using the HyperTraPS statistical platformEach study participant will be assessed over the 14 days following malaria diagnosisHypercubic transition path sampling (HyperTraPS) will be used to characterise patterns of recovery and identify predictors of fast vs slow recovery

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026