MeaslesNCT05614791
Evaluation of Pediatric Measles Cases in 2019: Single-Center Experience
An observational study of Measles, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
Measles, can be prevented and eliminated by vaccination, is a highly contagious viral disease that can lead to serious complications, disability, and death. As a result of the World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) strategic plans, the annual global… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Measles
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 May 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Measles case according to with clinical features and attended Pediatric Clinic between 01 January-30 June 2019
Who may be able to join
- The suspicious case of measles
- Measles/Rubella Case Notification and Laboratory request and result form and Measles/ Rubella Case Study form must be filled
- Accept the informed consent form
- Positive Measles Ig M and Measles Ig G laboratory test
Who cannot join
- Rejected the informed consent form
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Esenler Maternity and Child Health Hospital
Istanbul, Esenler, 34230
Haseki Training and Research Hospital
Istanbul
About this study
Measles, can be prevented and eliminated by vaccination, is a highly contagious viral disease that can lead to serious complications, disability, and death. As a result of the World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) strategic plans, the annual global incidence of measles decreased by 75% over the period 2000-2015, and the estimated global mortality rate fell by 73%. For the current 2019 period, the European and the Eastern Mediterranean Region has recorded respectively more than two-fold and 1.5-fold increase in reported measles cases. As it is known, no specific antiviral treatment exists for the measles virus therefore, vaccination is still the most effective method of preventing disease.
The aim of this study was to evaluate the measles cases in districts where the refugees live quite intensely.
Read the detailed description
Measles, can be prevented and eliminated by vaccination, is a highly contagious viral disease that can lead to serious complications, disability, and death. As a result of the World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) strategic plans, the annual global incidence of measles decreased by 75% over the period 2000-2015, and the estimated global mortality rate fell by 73%. For the current 2019 period, the European and the Eastern Mediterranean Region has recorded respectively more than two-fold and 1.5-fold increase in reported measles cases. As it is known, no specific antiviral treatment exists for the measles virus therefore, vaccination is still the most effective method of preventing disease.
The aim of this study was to evaluate the measles cases in districts where the refugees live quite intensely.
This retrospective study was consecutively enrolled children who were considered as suspicious measles case according to with clinical features and attended in Esenler Gynecology and Pediatrics Hospital Pediatric Clinic between 01 January-30 June 2019.
- Conditions
- Measles
- Keywords
- Measles, Vaccine, Children, Vitamin A
- Medical subject headings
- Measles
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of measles vaccination status on symptom duration
compare the groups symptom durations (day) who fully, partly or not vaccinated
Measured: baseline
Evaluate the effect of vitamin A treatment on symptom duration
compare the groups symptom durations (day) who get or not get vitamin A treatment
Measured: in the first month after the first symptom observed
Secondary outcomes (2)
Evaluate the effect of measles vaccination status on leucocyte count
compare the groups leucocyte count who fully, partly or not vaccinated
Measured: baseline
Evaluate the effect of vitamin A treatment on leucocyte count
compare the groups leucocyte count who get or not get vitamin A treatment
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Jan 2019
- Primary completion30 Jun 2019
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmut caner us, Marmara University
- Investigators
- Mahmut Caner US, MD, Principal investigator, haseki Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614791
- Sponsor's protocol ID
- 2019.10.2.02.075
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of data and material: When needed, all data can be shared with the consent of the participants.
Publications
Lord H, Kok J, Fletcher S, Alexander K. Is it or is it not? Lessons learned from a case of suspected vaccine strain measles. Aust N Z J Public Health. 2020 Apr;44(2):160-162. doi: 10.1111/1753-6405.12969. Epub 2020 Mar 19.
PubMed 32190947Lo Vecchio A, Krzysztofiak A, Montagnani C, Valentini P, Rossi N, Garazzino S, Raffaldi I, Di Gangi M, Esposito S, Vecchi B, Melzi ML, Lanari M, Zavarise G, Bosis S, Valenzise M, Cazzato S, Sacco M, Govoni MR, Mozzo E, Cambriglia MD, Bruzzese E, Di Camillo C, Pata D, Graziosi A, Sala D, Magurano F, Villani A, Guarino A, Galli L; SITIP Measles Study Group. Complications and risk factors for severe outcome in children with measles. Arch Dis Child. 2020 Sep;105(9):896-899. doi: 10.1136/archdischild-2018-315290. Epub 2019 Jan 12.
PubMed 30636224Filia A, Bella A, Del Manso M, Baggieri M, Magurano F, Rota MC. Ongoing outbreak with well over 4,000 measles cases in Italy from January to end August 2017 - what is making elimination so difficult? Euro Surveill. 2017 Sep 14;22(37):30614. doi: 10.2807/1560-7917.ES.2017.22.37.30614.
PubMed 28933342
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pediatric Measles Cases in 2019: Single-Center Experience
- ClinicalTrials.gov ID
- NCT05614791
- Acronym / sponsor ID
- 2019.10.2.02.075
- Conditions
- Measles
- Keywords
- Measles, Vaccine, Children, Vitamin A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 14 Nov 2022 (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.
Measles, can be prevented and eliminated by vaccination, is a highly contagious viral disease that can lead to serious complications, disability, and death. As a result of the World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) strategic plans, the annual global incidence of measles decreased by 75% over the period 2000-2015, and the estimated global mortality rate fell by 73%. For the current 2019 period, the European and the Eastern Mediterranean Region has recorded respectively more than two-fold and 1.5-fold increase in reported measles cases. As it is known, no specific antiviral treatment exists for the measles virus therefore, vaccination is still the most effective method of preventing disease.
The aim of this study was to evaluate the measles cases in districts where the refugees live quite intensely.
Detailed description
Measles, can be prevented and eliminated by vaccination, is a highly contagious viral disease that can lead to serious complications, disability, and death. As a result of the World Health Organization (WHO) and United Nations International Children's Emergency Fund (UNICEF) strategic plans, the annual global incidence of measles decreased by 75% over the period 2000-2015, and the estimated global mortality rate fell by 73%. For the current 2019 period, the European and the Eastern Mediterranean Region has recorded respectively more than two-fold and 1.5-fold increase in reported measles cases. As it is known, no specific antiviral treatment exists for the measles virus therefore, vaccination is still the most effective method of preventing disease.
The aim of this study was to evaluate the measles cases in districts where the refugees live quite intensely.
This retrospective study was consecutively enrolled children who were considered as suspicious measles case according to with clinical features and attended in Esenler Gynecology and Pediatrics Hospital Pediatric Clinic between 01 January-30 June 2019.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Measles case according to with clinical features and attended Pediatric Clinic between 01 January-30 June 2019
Key inclusion criteria (4 listed)
- The suspicious case of measles
- Measles/Rubella Case Notification and Laboratory request and result form and Measles/ Rubella Case Study form must be filled
- Accept the informed consent form
- Positive Measles Ig M and Measles Ig G laboratory test
Key exclusion criteria (1 listed)
- Rejected the informed consent form
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
Evaluate the effect of measles vaccination status on symptom duration
Time frame: baseline
compare the groups symptom durations (day) who fully, partly or not vaccinated
Evaluate the effect of vitamin A treatment on symptom duration
Time frame: in the first month after the first symptom observed
compare the groups symptom durations (day) who get or not get vitamin A treatment
2 secondary outcomes
Evaluate the effect of measles vaccination status on leucocyte count
Time frame: baseline
Evaluate the effect of vitamin A treatment on leucocyte count
Time frame: baseline
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 21 Nov 2024.
- Background: PubMed 32190947Lord H, Kok J, Fletcher S, Alexander K. Is it or is it not? Lessons learned from a case of suspected vaccine strain measles. Aust N Z J Public Health. 2020 Apr;44(2):160-162. doi: 10.1111/1753-6405.12969. Epub 2020 Mar 19.
- Background: PubMed 30636224Lo Vecchio A, Krzysztofiak A, Montagnani C, Valentini P, Rossi N, Garazzino S, Raffaldi I, Di Gangi M, Esposito S, Vecchi B, Melzi ML, Lanari M, Zavarise G, Bosis S, Valenzise M, Cazzato S, Sacco M, Govoni MR, Mozzo E, Cambriglia MD, Bruzzese E, Di Camillo C, Pata D, Graziosi A, Sala D, Magurano F, Villani A, Guarino A, Galli L; SITIP Measles Study Group. Complications and risk factors for severe outcome in children with measles. Arch Dis Child. 2020 Sep;105(9):896-899. doi: 10.1136/archdischild-2018-315290. Epub 2019 Jan 12.
- Background: PubMed 28933342Filia A, Bella A, Del Manso M, Baggieri M, Magurano F, Rota MC. Ongoing outbreak with well over 4,000 measles cases in Italy from January to end August 2017 - what is making elimination so difficult? Euro Surveill. 2017 Sep 14;22(37):30614. doi: 10.2807/1560-7917.ES.2017.22.37.30614.
- Individual participant dataSharing planned: Undecided. Availability of data and material: When needed, all data can be shared with the consent of the participants.
Related trials for Measles
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Heart Transplant Infection Prevention
Active, not recruitingPhase 1/2
MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma
Not yet recruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Measles, Mumps
RecruitingPhase 1
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma
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.
Mahmut Caner US, MD principal investigator
haseki Education and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Measles, run by Marmara University at 2 sites in Turkey (Türkiye).
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 4 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Evaluate the effect of measles vaccination status on symptom duration (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT05614791, which also lists 3 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 21 Nov 2024.