NCT05614791

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 6, 2022

Last Update Submit

November 19, 2024

Conditions

Keywords

MeaslesVaccineChildrenVitamin A

Outcome Measures

Primary Outcomes (2)

  • Evaluate the effect of measles vaccination status on symptom duration

    compare the groups symptom durations (day) who fully, partly or not vaccinated

    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

    in the first month after the first symptom observed

Secondary Outcomes (2)

  • Evaluate the effect of measles vaccination status on leucocyte count

    baseline

  • Evaluate the effect of vitamin A treatment on leucocyte count

    baseline

Other Outcomes (2)

  • Evaluate the effect of measles vaccination status on cost of measles cases

    in the first month after the first symptom observed

  • Evaluate the effect of vitamin A treatment on cost of measles cases

    in the first month after the first symptom observed

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Measles case according to with clinical features and attended Pediatric Clinic between 01 January-30 June 2019

You may qualify if:

  • 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

You may not qualify if:

  • Rejected the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Esenler Maternity and Child Health Hospital

Istanbul, Esenler, 34230, Turkey (Türkiye)

Location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 32190947BACKGROUND
  • Lo 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.

    PMID: 30636224BACKGROUND
  • Filia 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.

    PMID: 28933342BACKGROUND

MeSH Terms

Conditions

Measles

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Mahmut Caner US, MD

    haseki Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 14, 2022

Study Start

January 1, 2019

Primary Completion

June 30, 2019

Study Completion

May 30, 2020

Last Updated

November 21, 2024

Record last verified: 2022-11

Locations