MalariaMMSNCT05086887
Infections in Migrants in Sweden - the Importance of Malaria and Other Parasitic Infections
An observational study of Malaria and Parasitic Infection, run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria, Parasitic Infection
- What is being tested?
- Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases
- How many people
- 715 participants
- Where
- 1 siteSweden
- Study dates
- 15 Apr 2019to 30 Jun 2023
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Born in a malaria endemic country (a country with reported indigenous spread of malaria according to World Malaria Report 2019)
Who cannot join
- Inability to understand study information or sign informed consent, except for children where legal guardian is asked for consent.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Asylum Health Care Facilities in SLSO and Karolinska University Hospital
Stockholm
Andreas Wangdahl, +46731512904, andreas.wangdahl@ki.se
Anna Farnert, +46708843842, anna.farnert@sll.se
About this study
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.
Read the detailed description
Study participants are recruited in different ways, participation in the study is offered when attending an asylum health clinic at several sites in the Stockholm county. Secondly, patients attending the Infectious Disease outpatient clinic for non-febrile diseases (e.g. follow up of hepatitis, treatment for latent tuberculosis). Thirdly, quota refugees from Democratic Republic of the Congo or Uganda with arrival in Sweden in the years 2015-2019 with postal address in Stockholm, will be invited by letter to participate in the study .
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
- Malaria, Parasitic Infection
- Being tested
- Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases
- Keywords
- Migrant health, Malaria, Asymptomatic infections, Parasite prevalence, Screening
- Medical subject headings
- Malaria, Parasitic Diseases, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseasesDiagnostic test
All individuals are tested. Individuals with demonstrated parasitic disease are referred to the Infectious diseases or Pediatric clinic for evaluation and treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasite prevalence
Number of participants with ongoing malaria infection
Measured: 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: Measured at one occasion within 10 years from arrival in Sweden
Secondary outcomes (1)
Immune responses to malaria and other parasites
Levels and breadth of P. falciparum specific antibody and memory B cell responses.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start15 Apr 2019
- Primary completion1 Jan 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- 715 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anna Farnert, MD, Prof, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086887
- Sponsor's protocol ID
- MMS2019
- Acronym
- MMS
- Status last verified
- Oct 2021
- First submitted
- 31 Aug 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23953767Doolan 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.
PubMed 19136431Babiker 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.
PubMed 9790434Sifft 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.
PubMed 27842542Fernando 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.
PubMed 21171998Okell 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.
PubMed 23212366Asghar 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.
PubMed 25613889Marangi 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.
PubMed 19138412Matisz 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.
PubMed 21212221Maroushek 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.
PubMed 15876946Monge-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.
PubMed 22536477Karki 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.
PubMed 25337945Monge-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.
PubMed 21609263Chaves 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.
PubMed 28403765Stauffer 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.
PubMed 18689612
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infections in Migrants in Sweden - the Importance of Malaria and Other Parasitic Infections
- ClinicalTrials.gov ID
- NCT05086887
- Acronym / sponsor ID
- MMS / MMS2019
- Conditions
- Malaria, Parasitic Infection
- Keywords
- Migrant health, Malaria, Asymptomatic infections, Parasite prevalence, Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 715 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Oct 2021 (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.
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.
Detailed description
Study participants are recruited in different ways, participation in the study is offered when attending an asylum health clinic at several sites in the Stockholm county. Secondly, patients attending the Infectious Disease outpatient clinic for non-febrile diseases (e.g. follow up of hepatitis, treatment for latent tuberculosis). Thirdly, quota refugees from Democratic Republic of the Congo or Uganda with arrival in Sweden in the years 2015-2019 with postal address in Stockholm, will be invited by letter to participate in the study .
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migrants from malaria endemic countries arriving to or living in Sweden | – | Diagnostic Test: Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseasesThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Born in a malaria endemic country (a country with reported indigenous spread of malaria according to World Malaria Report 2019)
Key exclusion criteria (1 listed)
- Inability to understand study information or sign informed consent, except for children where legal guardian is asked for consent.
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 |
|---|---|---|
| Malaria diagnostic tests (RDT and PCR) and serology for malaria and other parasitic diseasesAll individuals are tested. Individuals with demonstrated parasitic disease are referred to the Infectious diseases or Pediatric clinic for evaluation and treatment. | Diagnostic test | Migrants from malaria endemic countries arriving to or living in Sweden |
Primary outcome
Parasite prevalence
Time frame: Measured at one occasion within 10 years from arrival in Sweden
Number of participants with ongoing malaria infection
Prevalence of other parasites focusing on strongyloides and schistosomiasis
Time frame: Measured at one occasion within 10 years from arrival in Sweden
Number of participants showing serological response to strongyloides and schistosomiasis
1 secondary outcome
Immune responses to malaria and other parasites
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Background: PubMed 23953767White 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.
- Background: PubMed 19136431Doolan 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.
- Background: PubMed 9790434Babiker 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.
- Background: PubMed 27842542Sifft 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.
- Background: PubMed 21171998Fernando 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.
- Background: PubMed 23212366Okell 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.
- Background: PubMed 25613889Asghar 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.
- Background: PubMed 19138412Marangi 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.
- Background: PubMed 21212221Matisz 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.
- Background: PubMed 15876946Maroushek 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.
- Background: PubMed 22536477Monge-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.
- Background: PubMed 25337945Karki 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.
- Individual participant dataSharing planned: Undecided
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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.
Anna Farnert, MD, Prof principal investigator
Karolinska University Hospital
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 Malaria and Parasitic Infection, run by Region Stockholm at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 21 Oct 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Wangdahl, MD (+46731512904, andreas.wangdahl@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite prevalence (time frame: Measured at one occasion within 10 years from arrival in Sweden). 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 NCT05086887, which also lists 23 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 Oct 2021.