Rheumatic FeverNCT03281863
Clinical Audit on the Managment in Assiut University Children Hospital
An observational study of Rheumatic Fever, run by Assiut University at 1 site in Egypt.
Trial summary
clinical audit on the Managment of rheumatic fever in assiut university children hospital. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Rheumatic Fever
- What is being tested?
- C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 24 Mar 2020
- 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 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Clinical audit on the managment of rheumatic fever in assiut university children hospital
Who may be able to join
- patients with confirmed diagnosis of rheumatic fever based on laboratory investigations.
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Audit on the Managment of Rheumatic Fever in Assiut University Children Hospital
clinical audit on the Managment of rheumatic fever in assiut university children hospital.
Read the detailed description
Acute rheumatic fever,an auto immune response to Group A streptococcus infection of the upper respiratory tract,may result in carditis.when the inflammation leads to permenant damage of the valves the individual has rheumatic heart disease.
Recurrences of rheumatic fever are likely in the absence of preventive measures and may cause further cardiac valve and muscle damage,leading to heart failure,stroke and premature death.bacterial endocarditis is also a complication.
- Conditions
- Rheumatic Fever
- Being tested
- C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate
- Medical subject headings
- Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rateDiagnostic test
Also called Throat culture
Throat culture to detect the causative organism
What is being measured
The primary outcome is the main question the study is designed to answer.
laboratory investigations (ASOt , ESR . CRP)
laboratory investigations that measure the inflammation process will be used and the target that the ASOt not increase 1/400
Measured: One year from October 2017 to september 2018
Secondary outcomes (1)
clinical measures
improvement of arthritis if found
Measured: One year from October 2017 to september 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Oct 2018
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic FeverStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia reda hanna, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281863
- Sponsor's protocol ID
- AssiutU71516
- Status last verified
- Mar 2021
- First submitted
- 29 Aug 2017
- Last updated
- 26 Mar 2021
- Results posted
- 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 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit on the Managment of Rheumatic Fever in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT03281863
- Acronym / sponsor ID
- AssiutU71516
- Conditions
- Rheumatic Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 13 Sep 2017 (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.
clinical audit on the Managment of rheumatic fever in assiut university children hospital.
Detailed description
Acute rheumatic fever,an auto immune response to Group A streptococcus infection of the upper respiratory tract,may result in carditis.when the inflammation leads to permenant damage of the valves the individual has rheumatic heart disease.
Recurrences of rheumatic fever are likely in the absence of preventive measures and may cause further cardiac valve and muscle damage,leading to heart failure,stroke and premature death.bacterial endocarditis is also a complication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Clinical audit on the managment of rheumatic fever in assiut university children hospital
Key inclusion criteria (1 listed)
- patients with confirmed diagnosis of rheumatic fever based on laboratory investigations.
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rateAlso: Throat cultureThroat culture to detect the causative organism | Diagnostic test | – |
Primary outcome
laboratory investigations (ASOt , ESR . CRP)
Time frame: One year from October 2017 to september 2018
laboratory investigations that measure the inflammation process will be used and the target that the ASOt not increase 1/400
1 secondary outcome
clinical measures
Time frame: One year from October 2017 to september 2018
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 26 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rheumatic Fever, run by Assiut University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 26 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 Egypt. 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?
laboratory investigations (ASOt , ESR . CRP) (time frame: One year from October 2017 to september 2018). 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 26 Mar 2021.