Infections in Migrants in Sweden - the Importance of Malaria and Other Parasitic Infections

NCT05086887 | Unknown DMC

• 1 other identifier: MMS2019
• Study Type: observational
• Target: 715
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria is a parasitic disease causing substantial morbidity and mortality globally. Malaria is a potentially severe and fatal disease in non-immune individuals. In areas of intense transmission infections individuals acquired immunity that protect against clinical disease. Nonetheless, immunity is not regarding sterilizing and repeated infections often result in an asymptomatic carriage of malaria parasites. These chronic apparently asymptomatic infections have been associated with anemia, cognitive dysfunction and adverse events during pregnancy. 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.

Conditions

Malaria; Parasitic Infection

Keywords

Migrant health; Malaria; Asymptomatic infections; Parasite prevalence; Screening

Outcome Measures

Primary Outcomes (2)

• Parasite prevalence

  Number of participants with ongoing malaria infection

  Measured at one occasion within 10 years from arrival in Sweden

• Prevalence of other parasites focusing on strongyloides and schistosomiasis

  Number of participants showing serological response to strongyloides and schistosomiasis

  Measured at one occasion within 10 years from arrival in Sweden

Secondary Outcomes (1)

• Immune responses to malaria and other parasites

  A blood specimen will be collected from participants upon inclusion, and a subset of volunteers will be asked to contribute with a second blood sample after 6-12 months

Study Arms (1)

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.

Diagnostic Test: Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases

Interventions

Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases DIAGNOSTIC_TEST

All individuals are tested. Individuals with demonstrated parasitic disease are referred to the Infectious diseases or Pediatric clinic for evaluation and treatment.

Migrants from malaria endemic countries arriving to or living in Sweden

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Migrants born in countries where malaria is endemic are invited to participate in the study at migration health care units and in the antenatal care during pregnancy. 2. Immigrants from malaria endemic countries living in Sweden are invited to participate with voluntary blood sampling on one occasion. The study is advertised in posters in waiting areas at health clinics. 3. Family members to individuals that are diagnosed with malaria at Karolinska University Hospital or other hospitals in Stockholm and Västerås are invited to the study at in-patient clinics. 4. Persons with origin in Democratic Republic of the Congo and Uganda arrived in Sweden between 2015-2019 are invited by an addressed letter

You may qualify if:

• Born in a malaria endemic country (a country with reported indigenous spread of malaria according to World Malaria Report 2019)

You may not qualify if:

• Inability to understand study information or sign informed consent, except for children where legal guardian is asked for consent.

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Asylum Health Care Facilities in SLSO and Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Related Publications (23)

• White NJ, Pukrittayakamee S, Hien TT, Faiz MA, Mokuolu OA, Dondorp AM. Malaria. Lancet. 2014 Feb 22;383(9918):723-35. doi: 10.1016/S0140-6736(13)60024-0. Epub 2013 Aug 15.

  PMID: 23953767 BACKGROUND

• Doolan DL, Dobano C, Baird JK. Acquired immunity to malaria. Clin Microbiol Rev. 2009 Jan;22(1):13-36, Table of Contents. doi: 10.1128/CMR.00025-08.

  PMID: 19136431 BACKGROUND

• Babiker HA, Abdel-Muhsin AM, Ranford-Cartwright LC, Satti G, Walliker D. Characteristics of Plasmodium falciparum parasites that survive the lengthy dry season in eastern Sudan where malaria transmission is markedly seasonal. Am J Trop Med Hyg. 1998 Oct;59(4):582-90. doi: 10.4269/ajtmh.1998.59.582.

  PMID: 9790434 BACKGROUND

• Sifft KC, Geus D, Mukampunga C, Mugisha JC, Habarugira F, Fraundorfer K, Bayingana C, Ndoli J, Umulisa I, Karema C, von Samson-Himmelstjerna G, Aebischer T, Martus P, Sendegeya A, Gahutu JB, Mockenhaupt FP. Asymptomatic only at first sight: malaria infection among schoolchildren in highland Rwanda. Malar J. 2016 Nov 14;15(1):553. doi: 10.1186/s12936-016-1606-x.

  PMID: 27842542 BACKGROUND

• Fernando SD, Rodrigo C, Rajapakse S. The 'hidden' burden of malaria: cognitive impairment following infection. Malar J. 2010 Dec 20;9:366. doi: 10.1186/1475-2875-9-366.

  PMID: 21171998 BACKGROUND

• Okell LC, Bousema T, Griffin JT, Ouedraogo AL, Ghani AC, Drakeley CJ. Factors determining the occurrence of submicroscopic malaria infections and their relevance for control. Nat Commun. 2012;3:1237. doi: 10.1038/ncomms2241.

  PMID: 23212366 BACKGROUND

• Asghar M, Hasselquist D, Hansson B, Zehtindjiev P, Westerdahl H, Bensch S. Chronic infection. Hidden costs of infection: chronic malaria accelerates telomere degradation and senescence in wild birds. Science. 2015 Jan 23;347(6220):436-8. doi: 10.1126/science.1261121.

  PMID: 25613889 BACKGROUND

• 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.

  PMID: 19138412 BACKGROUND

• 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.

  PMID: 21212221 BACKGROUND

• Maroushek SR, Aguilar EF, Stauffer W, Abd-Alla MD. Malaria among refugee children at arrival in the United States. Pediatr Infect Dis J. 2005 May;24(5):450-2. doi: 10.1097/01.inf.0000160948.22407.0d.

  PMID: 15876946 BACKGROUND

• Monge-Maillo B, Lopez-Velez R. Migration and malaria in europe. Mediterr J Hematol Infect Dis. 2012;4(1):e2012014. doi: 10.4084/MJHID.2012.014. Epub 2012 Mar 10.

  PMID: 22536477 BACKGROUND

• 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.

  PMID: 25337945 BACKGROUND

• 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.

  PMID: 21609263 BACKGROUND

• Chaves NJ, Paxton GA, Biggs BA, Thambiran A, Gardiner J, Williams J, Smith MM, Davis JS. The Australasian Society for Infectious Diseases and Refugee Health Network of Australia recommendations for health assessment for people from refugee-like backgrounds: an abridged outline. Med J Aust. 2017 Apr 17;206(7):310-315. doi: 10.5694/mja16.00826.

  PMID: 28403765 BACKGROUND

• 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.

  PMID: 18689612 BACKGROUND

• Njama-Meya D, Kamya MR, Dorsey G. Asymptomatic parasitaemia as a risk factor for symptomatic malaria in a cohort of Ugandan children. Trop Med Int Health. 2004 Aug;9(8):862-8. doi: 10.1111/j.1365-3156.2004.01277.x.

  PMID: 15303990 BACKGROUND

• 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.

  PMID: 18945569 BACKGROUND

• Cowman AF, Healer J, Marapana D, Marsh K. Malaria: Biology and Disease. Cell. 2016 Oct 20;167(3):610-624. doi: 10.1016/j.cell.2016.07.055.

  PMID: 27768886 BACKGROUND

• Langhorne J, Ndungu FM, Sponaas AM, Marsh K. Immunity to malaria: more questions than answers. Nat Immunol. 2008 Jul;9(7):725-32. doi: 10.1038/ni.f.205.

  PMID: 18563083 BACKGROUND

• 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.

  PMID: 25656623 BACKGROUND

• Shokoples SE, Ndao M, Kowalewska-Grochowska K, Yanow SK. Multiplexed real-time PCR assay for discrimination of Plasmodium species with improved sensitivity for mixed infections. J Clin Microbiol. 2009 Apr;47(4):975-80. doi: 10.1128/JCM.01858-08. Epub 2009 Feb 25.

  PMID: 19244467 BACKGROUND

• 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.

  PMID: 23983244 BACKGROUND

• Yman V, White MT, Rono J, Arca B, Osier FH, Troye-Blomberg M, Bostrom S, Ronca R, Rooth I, Farnert A. Antibody acquisition models: A new tool for serological surveillance of malaria transmission intensity. Sci Rep. 2016 Feb 5;6:19472. doi: 10.1038/srep19472.

  PMID: 26846726 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood 10ml, except in small children where 5ml are collected.

MeSH Terms

Conditions

Malaria; Parasitic Diseases; Asymptomatic Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Farnert, MD, Prof

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Wangdahl, MD

CONTACT

+46731512904; andreas.wangdahl@ki.se

Anna Farnert, MD, Prof

CONTACT

++46 708843842; anna.farnert@sll.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: October 21, 2021
• Study Start: April 15, 2019
• Primary Completion: January 1, 2023
• Study Completion: June 30, 2023
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

SE (1)