Longitudinal Observational Study With 6 Months Follow-upSIDINCT04947358
Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia
An observational study of Longitudinal Observational Study With 6 Months Follow-up, run by S Form Pharma at 1 site in Tunisia.
Trial summary
The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Longitudinal Observational Study With 6 Months Follow-up
- How many people
- 180 participants
- Where
- 1 siteTunisia
- Study dates
- 22 Feb 2019to 30 Dec 2021
- 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 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients admitted for unexpected respiratory difficulty
Who may be able to join
- Patients admitted for unexpected respiratory difficulty
- Patient admitted to the emergency department
- One of the following 3 criteria have to be present at admission to the ER:
- O2 < or = 95%
- Respiratory rate RR > or = 20
- Suffocation sensation
Who cannot join
- Patients <18 years old and> 85 years' old
- Pregnancy
- History of allergic asthma at early age
- Diagnosis retained of pulmonary embolism
- Patients with heart failure (HF) with left ventricular ejection fraction LVEF <40% are known beforehand or discovered at admission to ER
- known Allergy for Polyamide; Polyester; Elastane; Silicone; Silver; Synthetic material Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax Open wound on the skin, at the level of the trunk
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
ER, Fattouma Bourguiba Hospital
Monastir
Semir Nouira, +21673106085, semir.nouira@rns.tn
Riadh Boukef
About this study
The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital
Define the proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital for patients admitted to the Emergency Department for acute dyspnea
Measured: 3 months
Secondary outcomes (1)
Proportion and causes of re-hospitalization and deaths within 6 months of discharge from hospital
Check theses parameters at 6 months, differentiating the cardiac causes from non-cardiac causes and the effect of home follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start22 Feb 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Longitudinal Observational Study With 6 Months Follow-upStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S Form Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947358
- Sponsor's protocol ID
- AD201801
- Acronym
- SIDI
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2019
- Last updated
- 1 Jul 2021
- Results posted
- 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia
- ClinicalTrials.gov ID
- NCT04947358
- Acronym / sponsor ID
- SIDI / AD201801
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- S Form PharmaIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 1 Jul 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.
The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for unexpected respiratory difficulty
Key inclusion criteria (6 listed)
- Patients admitted for unexpected respiratory difficulty
- Patient admitted to the emergency department
- One of the following 3 criteria have to be present at admission to the ER:
- O2 < or = 95%
- Respiratory rate RR > or = 20
Key exclusion criteria (6 listed)
- Patients <18 years old and> 85 years' old
- Pregnancy
- History of allergic asthma at early age
- Diagnosis retained of pulmonary embolism
- Patients with heart failure (HF) with left ventricular ejection fraction LVEF <40% are known beforehand or discovered at admission to ER
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital
Time frame: 3 months
Define the proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital for patients admitted to the Emergency Department for acute dyspnea
1 secondary outcome
Proportion and causes of re-hospitalization and deaths within 6 months of discharge from hospital
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Individual participant dataSharing planned: Undecided
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.
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 Longitudinal Observational Study With 6 Months Follow-up, run by S Form Pharma at 1 site in Tunisia.
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 6 inclusion and 6 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 1 Jul 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 Tunisia. 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 Eric Halioua, CEO (+32474057866, halioua_eric@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital (time frame: 3 months). 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 1 Jul 2021.