Respiratory Tract InfectionsCROCODILE-INCT05971901
A Combinatorial Biomarker for Infection Diagnosis in Children
An observational study of Respiratory Tract Infections and Fever, run by Universität des Saarlandes at 4 sites in Germany.
Trial summary
To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and CRP) is used, and to compare them with control patients without BV measurement. Read more about this study
- Who is it for?
- Ages 5 months and older
- Conditions the study is for
- Respiratory Tract Infections, Fever
- What is being tested?
- BV
- How many people
- 770 participants
- Where
- 4 sitesGermany
- Study dates
- 24 Feb 2023to Nov 2024
- 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 5 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients for whom the treating physicians request the determination of the BV score from the patient's serum due to a suspected infection can be included in this study, provided that they meet the above inclusion criteria, are capable of giving consent and agree to participate in the study (or, in the case of incapacitated patients, written consent is obtained from their legal guardian, health care proxy or custodian).
Who may be able to join
- Suspicion of acute bacterial or viral infection
- Requirement of at least one BV test during medical presentation
Who cannot join
- lack of informed consent
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Not yet recruiting
Sana Kliniken
Berlin
Tobias Tenenbaum, MD, 00493055185131, Tobias.Tenenbaum@Sana.de
- Not yet recruiting
Universitätsklinikum Bonn
Bonn
Cihan Papan, MD, 004922828714639, cihan.papan@ukbonn.de
- Recruiting
Saarland University
Homburg, 66421
Cihan Papan, MD, 004968411623900, cihan.papan@uni-saarland.de
Soeren Becker, MD, PhD, 004968411623900, soeren.becker@uks.eu
- Not yet recruiting
Universitätsklinikum Würzburg
Würzburg
Johannes Liese, MD, 004993120127725, Liese_J@ukw.de
About this study
To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and CRP) is used, and to compare them with control patients without BV measurement.
Secondary objectives:
- Qualitative evaluation of indication as well as adherence to the test result.
- Comparison of antimicrobial therapy, performed diagnostics, hospitalization, and outcomes between patients with high BV score (bacterial) and patients with low BV score (viral).
- Conditions
- Respiratory Tract Infections, Fever
- Being tested
- BV
- Medical subject headings
- Respiratory Tract Infections, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVDiagnostic test
The use of the BV test, ordered at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| BV use cases | cases in whom BV was ordered Receives: Diagnostic Test: BV | |
| BV non-use cases | cases in whom BV was not ordered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotics
Number of participants treated with antibiotics
Measured: up to 30 days
Secondary outcomes (4)
Antibiotic duration
Length of antibiotic treatment per participant
Measured: up to 30 days
Hospitalization
Number of participants admitted to the hospital
Measured: up to 30 days
Complications
Rate of complications per participant
Measured: up to 30 days
Tests
Rate of ancillary tests per participant
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start24 Feb 2023
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies 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
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihan Papan, Universität des Saarlandes
- Investigators
- Cihan Papan, MD, Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971901
- Sponsor's protocol ID
- 233/22
- Acronym
- CROCODILE-I
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combinatorial Biomarker for Infection Diagnosis in Children
- ClinicalTrials.gov ID
- NCT05971901
- Acronym / sponsor ID
- CROCODILE-I / 233/22
- Conditions
- Respiratory Tract Infections, Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 2 Aug 2023 (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.
To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and CRP) is used, and to compare them with control patients without BV measurement.
Secondary objectives:
- Qualitative evaluation of indication as well as adherence to the test result.
- Comparison of antimicrobial therapy, performed diagnostics, hospitalization, and outcomes between patients with high BV score (bacterial) and patients with low BV score (viral).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BV use cases | – | Diagnostic Test: BVcases in whom BV was ordered |
| BV non-use cases | – | –cases in whom BV was not ordered |
Who may qualify
- Ages
- 5 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients for whom the treating physicians request the determination of the BV score from the patient's serum due to a suspected infection can be included in this study, provided that they meet the above inclusion criteria, are capable of giving consent and agree to participate in the study (or, in the case of incapacitated patients, written consent is obtained from their legal guardian, health care proxy or custodian).
Key inclusion criteria (2 listed)
- Suspicion of acute bacterial or viral infection
- Requirement of at least one BV test during medical presentation
Key exclusion criteria (1 listed)
- lack of informed 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 |
|---|---|---|
| BVThe use of the BV test, ordered at the discretion of the treating physician | Diagnostic test | BV use cases |
Primary outcome
Antibiotics
Time frame: up to 30 days
Number of participants treated with antibiotics
4 secondary outcomes
Antibiotic duration
Time frame: up to 30 days
Hospitalization
Time frame: up to 30 days
Complications
Time frame: up to 30 days
Tests
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Cihan Papan, MD principal investigator
Universität des Saarlandes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Fever, run by Universität des Saarlandes at 4 sites in Germany.
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 2 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 Cihan Papan, MD (+4968411623900, cihan.papan@uni-saarland.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotics (time frame: up to 30 days). 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 2 Aug 2023.