MalariaSCRIPTNCT05149157
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
An observational study of Malaria, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 8 days and older
- Conditions the study is for
- Malaria
- What is being tested?
- Symptomatic malaria
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2022to 5 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film
Who may be able to join
- Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Search for Correlates of Recovery in the 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.
- Conditions
- Malaria
- Being tested
- Symptomatic malaria
- Keywords
- Malaria, Recovery, Transcriptomics
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptomatic malariaOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each study participant will be assessed over the 14 days following malaria diagnosis
Secondary outcomes (3)
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.
Measured: 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
Rates of recovery will be calculated for individual markers of tissue, organ, or organ system dysfunction
Measured: 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
Hypercubic transition path sampling (HyperTraPS) will be used to characterise patterns of recovery and identify predictors of fast vs slow recovery
Measured: Each study participant will be assessed over the 14 days following malaria diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start2 Aug 2022
- Primary completion5 Jan 2028 (estimated)
- Study completion5 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aubrey Cunnington, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149157
- Sponsor's protocol ID
- 21SM7226
- Acronym
- SCRIPT
- Status last verified
- Nov 2026
- First submitted
- 25 Nov 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for Correlates of Recovery in the Patient Transcriptome (SCRIPT) (Malaria) Study
- ClinicalTrials.gov ID
- NCT05149157
- Acronym / sponsor ID
- SCRIPT / 21SM7226
- Conditions
- Malaria
- Keywords
- Malaria, Recovery, Transcriptomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 5 Jan 2028 (estimated)
- Study completion
- 5 Jan 2028 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film
Key inclusion criteria (1 listed)
- Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptomatic malariaThis observational study will be recruiting patients who have symptomatic malaria (confirmed by presence of asexual stage parasitaemia of any Plasmodium species on blood film) | Other | – |
Primary outcome
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.
3 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
Time frame: 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
Time frame: 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
Time frame: Each study participant will be assessed over the 14 days following malaria diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aubrey Cunnington, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.