Cystic FibrosisMACRODUCT-3710NCT03913507
Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
A study testing Macroduct® Advanced Model 3710 SYS, Wescor in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. Read more about this study
- Who is it for?
- Ages 2 days to 12 months
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Macroduct® Advanced Model 3710 SYS, Wescor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jul 2018to 22 Mar 2021
- Phase
- Interventional
- 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 2 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject aged of 2 days to 12 months
- Indication of a sweat test prescribed by a clinician in a context of neonatal screening
- Clinically stable
- Well hydrated
- Not under treatment with mineralocorticoids
Who cannot join
- Subjects weighing less than 2 kg
- Subjects less than 48 hours old
- Presence of an acute infectious condition
- Presence of mineralocorticoid treatment
Trial locations and contacts
1 site in 1 country.
About this study
In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. In children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease.
In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat Collection System, Wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.
- Conditions
- Cystic Fibrosis
- Being tested
- Macroduct® Advanced Model 3710 SYS, Wescor
- Keywords
- Cystic Fibrosis Children
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macroduct® Advanced Model 3710 SYS, WescorDevice
for each subject, both methods will be tested in order to compare the efficacy of the new sweat collection method (Macroduct® Advanced Model 3710 SYS, Wescor) to the method currently used in clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| one group : patients with suspicion of cystic fibrosis | Experimental | Not described Receives: Device: Macroduct® Advanced Model 3710 SYS, Wescor |
What is being measured
The primary outcome is the main question the study is designed to answer.
chloride concentration
The volume and the chloride concentration will be analyzed for each subject.
Measured: day 1
Secondary outcomes (1)
sweat
sweat collected with sweat collection method (Macroduct® Advanced) Model 3710 SYS, Wescor) compared with that currently used in clinical routine.
The effectiveness criterion of the new Macroduct Advanced collector will be defined as follows: the new device tested will be considered effective if the insufficient amount of sweat levels obtained are smaller or equal to those recommended, i.e. if it is lower than 10% in children under 3 months and below 5% in children between 3 and 12 months.
The insufficient amount of sweat rates will be compared between the two methods.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start14 Jul 2018
- Primary completion31 Dec 2020
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresinha Leal, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913507
- Sponsor's protocol ID
- 2018/14JUI/253
- Acronym
- MACRODUCT-3710
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2019
- Last updated
- 24 Mar 2021
- 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 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03913507
- Acronym / sponsor ID
- MACRODUCT-3710 / 2018/14JUI/253
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 14 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 12 Apr 2019 (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.
In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. In children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease.
In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat Collection System, Wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group : patients with suspicion of cystic fibrosis | Experimental | Device: Macroduct® Advanced Model 3710 SYS, Wescor |
Who may qualify
- Ages
- 2 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject aged of 2 days to 12 months
- Indication of a sweat test prescribed by a clinician in a context of neonatal screening
- Clinically stable
- Well hydrated
- Not under treatment with mineralocorticoids
Key exclusion criteria (4 listed)
- Subjects weighing less than 2 kg
- Subjects less than 48 hours old
- Presence of an acute infectious condition
- Presence of mineralocorticoid treatment
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 |
|---|---|---|
| Macroduct® Advanced Model 3710 SYS, Wescorfor each subject, both methods will be tested in order to compare the efficacy of the new sweat collection method (Macroduct® Advanced Model 3710 SYS, Wescor) to the method currently used in clinical routine. | Device | one group : patients with suspicion of cystic fibrosis |
Primary outcome
chloride concentration
Time frame: day 1
The volume and the chloride concentration will be analyzed for each subject.
1 secondary outcome
sweat
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- 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.
Teresinha Leal principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macroduct® Advanced Model 3710 SYS, Wescor in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 24 Mar 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
chloride concentration (time frame: day 1). 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 24 Mar 2021.