Banor och mekanismer för återhämtning från malaria: en observationsstudie (SCRIPT)
Sök efter Correlates of Recovery i Patient Transcriptome (SCRIPT) (Malaria) 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
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London, Storbritannien
- Imperial College Healthcare NHS Trust
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Genes for which expression (level of gene activity) correlates with a 'composite recovery score'
Tidsram: 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. |
Each study participant will be assessed over the 14 days following malaria diagnosis
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Genes for which expression (level of gene activity) correlates with rate of recovery for individual markers of tissue, organ, or organ system dysfunction
Tidsram: 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. |
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
Tidsram: 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 |
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
Tidsram: 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 |
Each study participant will be assessed over the 14 days following malaria diagnosis
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Aubrey Cunnington, PhD, Imperial College London
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 21SM7226
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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