Trajectories and Mechanisms of Recovery From Malaria: An Observational Study

Malaria Clinical Trial

— SCRIPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149157
• Other study ID #: 21SM7226
• Status: Recruiting
• Start date: August 2, 2022
• Est. completion date: January 5, 2026

Study information

• Verified date: August 2022
• Source: Imperial College London
• Contact: Aubrey Cunnington, PhD
• Phone: +44 (0) 2075943695
• Email: a.cunnington[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 5, 2026
• Est. primary completion date: January 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Days and older

Eligibility

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.

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• Symptomatic 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)

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genes for which expression (level of gene activity) correlates with a 'composite recovery score'	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.	Each study participant will be assessed over the 14 days following malaria diagnosis
Secondary	Genes for which expression (level of gene activity) correlates with rate of recovery for individual markers of tissue, organ, or organ system dysfunction	Genes for which expression correlates with the individual markers of tissue, organ, or organ system dysfunction will be identified by whole blood transcriptome analysis.	Each study participant will be assessed over the 14 days following malaria diagnosis
Secondary	Rate of recovery for individual markers of tissue, organ, or organ system dysfunction	Rates of recovery will be calculated for individual markers of tissue, organ, or organ system dysfunction	Each study participant will be assessed over the 14 days following malaria diagnosis
Secondary	Sequences of clinical events predictive of recovery, as determined by Bayesian inference of dynamic pathways using the HyperTraPS statistical platform	Hypercubic transition path sampling (HyperTraPS) will be used to characterise patterns of recovery and identify predictors of fast vs slow recovery	Each study participant will be assessed over the 14 days following malaria diagnosis