Lower Respiratory Tract InfectionRASCALSNCT04233268
RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
An observational study of Lower Respiratory Tract Infection and Ventilator Associated Pneumonia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. Read more about this study
- Who is it for?
- Ages 0 months to 16 years
- Conditions the study is for
- Lower Respiratory Tract Infection, Ventilator Associated Pneumonia, COVID19
- What is being tested?
- Rapid Pathogen Detection
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2020to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically ill children with suspected lower respiratory tract infection
Who may be able to join
- Aged >37 weeks corrected gestation and ≤16 years old
- Receiving mechanical ventilation
- Commencing or already receiving antibiotic treatment for lower respiratory tract infection
Who cannot join
- 1. Survival not expected/active medical treatment expected to be withdrawn/palliative care only
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge, Cambs, CB2 9NS
Nazima Pathan, FRCPCH PhD
About this study
Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. The exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. In many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken.
A rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed.
This study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.
- Being tested
- Rapid Pathogen Detection
- Medical subject headings
- Pneumonia, Ventilator-Associated, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Pathogen DetectionDiagnostic test
Rapid assays for pathogen detection on bronchoalveolar lavage fluid
| Study group | Role | What they receive |
|---|---|---|
| Critically ill children | Children with severe infection requiring mechanical ventilation Receives: Diagnostic Test: Rapid Pathogen Detection | |
| Non critically ill cohort | Children with severe infection admitted to hospital but not requiring mechanical ventilation | |
| Profiling of the respiratory microbiome | Mechanically ventilated children of any cause admitted to PICU Receives: Diagnostic Test: Rapid Pathogen Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the novel pathogen detection assay
Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios
Measured: 3 years
Secondary outcomes (3)
Time to results
Time to reportable test results
Measured: 3 years
Negative cultures
Where routine culture is negative, what proportion of tests have a positive detection using the novel assay?
Measured: 3 years
Antibiotic therapy
Duration of therapy and number of antibiotic classes during paediatric intensive care unit admission
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start6 Jun 2020
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nazima Pathan, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Nazima Pathan, FRCPCH PhD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233268
- Sponsor's protocol ID
- 277039
- Acronym
- RASCALS
- Status last verified
- Oct 2021
- First submitted
- 15 Jan 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark JA, Conway Morris A, Kanaris C, Inwald D, Butt W, Osowicki J, Schlapbach LJ, Curran MD, White D, Daubney E, Agrawal S, Navapurkar V, Torok ME, Baker S, Pathan N. A qualitative investigation of paediatric intensive care staff attitudes towards the diagnosis of lower respiratory tract infection in the molecular diagnostics era. Intensive Care Med Paediatr Neonatal. 2023;1(1):10. doi: 10.1007/s44253-023-00008-z. Epub 2023 Jul 7.
PubMed 37425493Clark JA, Kean IRL, Curran MD, Khokhar F, White D, Daubney E, Conway Morris A, Navapurkar V, Bartholdson Scott J, Maes M, Bousfield R, Gouliouris T, Agrawal S, Inwald D, Zhang Z, Torok ME, Baker S, Pathan N. Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol. BMJ Open. 2021 Nov 29;11(11):e056197. doi: 10.1136/bmjopen-2021-056197.
PubMed 34845080
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
- ClinicalTrials.gov ID
- NCT04233268
- Acronym / sponsor ID
- RASCALS / 277039
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 18 Jan 2020 (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.
Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. The exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. In many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken.
A rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed.
This study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Critically ill children | – | Diagnostic Test: Rapid Pathogen DetectionChildren with severe infection requiring mechanical ventilation |
| Non critically ill cohort | – | –Children with severe infection admitted to hospital but not requiring mechanical ventilation |
| Profiling of the respiratory microbiome | – | Diagnostic Test: Rapid Pathogen DetectionMechanically ventilated children of any cause admitted to PICU |
Who may qualify
- Ages
- 0 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically ill children with suspected lower respiratory tract infection
Key inclusion criteria (3 listed)
- Aged >37 weeks corrected gestation and ≤16 years old
- Receiving mechanical ventilation
- Commencing or already receiving antibiotic treatment for lower respiratory tract infection
Key exclusion criteria (1 listed)
- 1. Survival not expected/active medical treatment expected to be withdrawn/palliative care only
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 |
|---|---|---|
| Rapid Pathogen DetectionRapid assays for pathogen detection on bronchoalveolar lavage fluid | Diagnostic test | Critically ill children, Profiling of the respiratory microbiome |
Primary outcome
Performance of the novel pathogen detection assay
Time frame: 3 years
Performance of novel pathogen detection assays compared to standard microbiology, in regard to sensitivity, specificity and likelihood ratios
3 secondary outcomes
Time to results
Time frame: 3 years
Negative cultures
Time frame: 3 years
Antibiotic therapy
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Derived from this study: PubMed 37425493Clark JA, Conway Morris A, Kanaris C, Inwald D, Butt W, Osowicki J, Schlapbach LJ, Curran MD, White D, Daubney E, Agrawal S, Navapurkar V, Torok ME, Baker S, Pathan N. A qualitative investigation of paediatric intensive care staff attitudes towards the diagnosis of lower respiratory tract infection in the molecular diagnostics era. Intensive Care Med Paediatr Neonatal. 2023;1(1):10. doi: 10.1007/s44253-023-00008-z. Epub 2023 Jul 7.
- Derived from this study: PubMed 34845080Clark JA, Kean IRL, Curran MD, Khokhar F, White D, Daubney E, Conway Morris A, Navapurkar V, Bartholdson Scott J, Maes M, Bousfield R, Gouliouris T, Agrawal S, Inwald D, Zhang Z, Torok ME, Baker S, Pathan N. Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol. BMJ Open. 2021 Nov 29;11(11):e056197. doi: 10.1136/bmjopen-2021-056197.
- 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.
Nazima Pathan, FRCPCH PhD principal investigator
Cambridge University Hospitals NHS Foundation Trust
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 Lower Respiratory Tract Infection and Ventilator Associated Pneumonia, run by Cambridge University Hospitals NHS Foundation Trust 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 3 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: status not confirmed, as of the sponsor's last update on 20 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazima Pathan, FRCPCH PhD (01225245151, np409@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the novel pathogen detection assay (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04233268, which also lists 2 linked publications.
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 20 Oct 2021.