Search for Correlates of Recovery in the Patient Transcriptome (SCRIPT) (Malaria) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- Imperial College London
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Genes for which expression (level of gene activity) correlates with a 'composite recovery score'
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- 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)
- 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)
- 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)