Infections in Migrants in Sweden - the Importance of Malaria and Other Parasitic Infections
NCT ID: NCT05086887
Last Updated: 2021-10-21
Study Results
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Basic Information
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UNKNOWN
715 participants
OBSERVATIONAL
2019-04-15
2023-06-30
Brief Summary
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Global migration has increased over the last decade and has resulted in an increasing number of migrants from malaria endemic regions arriving in non-endemic countries. Migrants from malaria endemic countries may carry asymptomatic infections with malaria parasites, as well as other parasitic infections such as strongyloides and schistosomiasis, with a possible negative impact on health in this group. The prevalence of asymptomatic malaria and other parasites is not fully elucidated in migrants from different regions. Moreover, the longevity of asymptomatic carriage of malaria parasites in absence of re-exposure is not known.
The aim of this study is to assess the prevalence of malaria parasites and other parasitic infections in migrants in Sweden, both newly arrived and migrants with longer residency, and intend to evaluate the need for screening for various parasitic infections in migrants arriving in Sweden. Moreover, this study will also assess antibody responses to malaria and other parasitic diseases.
Detailed Description
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A venous blood sample (EDTA tube) is collected from study participants at one occasion and a questionnaire including questions about patient origin and previous malaria are completed with the aid of a translator.
Blood samples are analysed in the research laboratory, where a malaria rapid diagnostic test (RDT) is performed and haemoglobin concentrations are measured (using Hemocue, point of care test) the same day as sample collection. The samples are then centrifuged, aliquoted, and stored frozen at the research laboratory. Presence of malaria parasites are analysed by realtime-PCR of the species specific 18SRNA gene in a multiplex assay. Serologic markers for other parasitic diseases (eg. schistosomiasis and strongyloides) are analysed in plasma. These analyses are performed at the reference laboratory at the Public Health Agency of Sweden.
Projected sample size is estimated using the formula n=(Z\^2xP(1-P))/d\^2 where P is the expected prevalence based on previous studies (5%) and d is the precision (1.5%) and Z is the confidence interval (95%). Based on these assumptions, the required sample size is n=715.
All RDT or PCR positive individuals are referred to the Department of Infectious Diseases or the Department of Pediatrics at the regional hospital for further investigations and treatment. Results from complete blood count are assessed and followed up according to clinical routine at each centre where samples were collected. Contact information to the study participant are included as part of the recruitment and consent procedures in order to be able to contact the study participants for referral.
Moreover, antibody responses to crude parasite extracts and specific antigens are assessed by ELISA and Luminex. In a subset of participants peripheral blood mononuclear cells, PBMC, are prepared in follow up samples to assess the cellular immune response. The magnitude and breadth of antibody and cellular responses are assessed in relation to duration of residency in a malaria free country. An estimation of the long- term decay kinetics using a sero-epidemiological mathematical model is performed.
All data will be handled according to the EU GDPR (General Data Protection Regulation) superseded all EU member states' data protection laws based on the 1995 Data Protection Directive (DPD), (GDPR, EU 2016/679 and SFS 2018:218). The patient register, containing all collected data and analysis results, is kept pseudonymizised and stored in a secure server at Karolinska University Hospital. The key to pseudonumization is kept in a secure locker at the institution.
Collected blood specimens are stored in Stockholm Medical Biobank located at Karolinska University Hospital in Solna. Handling of these stored samples is governed by the Act on Biobanks in Health Care (SFS 2002: 297).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Migrants from malaria endemic countries arriving to or living in Sweden
The study population consists of participants born in a malaria endemic country living in Sweden, irrespective of time of residency in Sweden (e.g newly arrived migrants as well as individuals with longer residency in Sweden or another non-endemic country). Participants of all ages can be included in the study.
Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases
All individuals are tested. Individuals with demonstrated parasitic disease are referred to the Infectious diseases or Pediatric clinic for evaluation and treatment.
Interventions
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Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases
All individuals are tested. Individuals with demonstrated parasitic disease are referred to the Infectious diseases or Pediatric clinic for evaluation and treatment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Region Stockholm
OTHER_GOV
Responsible Party
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Principal Investigators
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Anna Farnert, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
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Asylum Health Care Facilities in SLSO and Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Marangi M, Di Tullio R, Mens PF, Martinelli D, Fazio V, Angarano G, Schallig HD, Giangaspero A, Scotto G. Prevalence of Plasmodium spp. in malaria asymptomatic African migrants assessed by nucleic acid sequence based amplification. Malar J. 2009 Jan 12;8:12. doi: 10.1186/1475-2875-8-12.
Matisz CE, Naidu P, Shokoples SE, Grice D, Krinke V, Brown SZ, Kowalewska-Grochowska K, Houston S, Yanow SK. Post-arrival screening for malaria in asymptomatic refugees using real-time PCR. Am J Trop Med Hyg. 2011 Jan;84(1):161-5. doi: 10.4269/ajtmh.2011.10-0494.
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Karki T, Napoli C, Riccardo F, Fabiani M, Dente MG, Carballo M, Noori T, Declich S. Screening for infectious diseases among newly arrived migrants in EU/EEA countries--varying practices but consensus on the utility of screening. Int J Environ Res Public Health. 2014 Oct 21;11(10):11004-14. doi: 10.3390/ijerph111011004.
Monge-Maillo B, Lopez-Velez R. Is screening for malaria necessary among asymptomatic refugees and immigrants coming from endemic countries? Expert Rev Anti Infect Ther. 2011 May;9(5):521-4. doi: 10.1586/eri.11.37.
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Stauffer WM, Weinberg M, Newman RD, Causer LM, Hamel MJ, Slutsker L, Cetron MS. Pre-departure and post-arrival management of P. falciparum malaria in refugees relocating from sub-Saharan Africa to the United States. Am J Trop Med Hyg. 2008 Aug;79(2):141-6.
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Szmitko PE, Kohn ML, Simor AE. Plasmodium falciparum malaria occurring 8 years after leaving an endemic area. Diagn Microbiol Infect Dis. 2009 Jan;63(1):105-7. doi: 10.1016/j.diagmicrobio.2008.08.017. Epub 2008 Oct 21.
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Farnert A, Wyss K, Dashti S, Naucler P. Duration of residency in a non-endemic area and risk of severe malaria in African immigrants. Clin Microbiol Infect. 2015 May;21(5):494-501. doi: 10.1016/j.cmi.2014.12.011. Epub 2014 Dec 26.
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Rono J, Osier FH, Olsson D, Montgomery S, Mhoja L, Rooth I, Marsh K, Farnert A. Breadth of anti-merozoite antibody responses is associated with the genetic diversity of asymptomatic Plasmodium falciparum infections and protection against clinical malaria. Clin Infect Dis. 2013 Nov;57(10):1409-16. doi: 10.1093/cid/cit556. Epub 2013 Aug 27.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MMS2019
Identifier Type: -
Identifier Source: org_study_id