Trajectories and Mechanisms of Recovery From Malaria: An Observational Study

Active, not recruiting

• Conditions: Malaria

• Registration Number: NCT05149157
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-11-25
• Study First Posted: 2021-12-08
• Study Start: 2022-08-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-01-05
• Study Completion: 2026-01-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 Outcome Measures

Name	Time	Method
Genes for which expression (level of gene activity) correlates with rate of recovery for individual markers of tissue, organ, or organ system dysfunction	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.
Rate of recovery for individual markers of tissue, organ, or organ system dysfunction	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
Sequences of clinical events predictive of recovery, as determined by Bayesian inference of dynamic pathways using the HyperTraPS statistical platform	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

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom