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Clinical Trials/NL-OMON50610
NL-OMON50610WithdrawnNot Applicable

Immunological and Genetic Risk factors for Cardiac Serious Adverse Events following Controlled Human Malaria Infections: a Case-Control study - Risk factors for cardiac SAEs following CHMI

Radboud Universitair Medisch Centrum0 sites25 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
25
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 64 (—)

Inclusion Criteria

  • •In order to be eligible to participate in this study as a case, a subject must
  • •meet all of the following criteria:
  • •1. Subject must sign written informed consent to participate in the trial.
  • •2. By judgement of the clinical investigator, the subject is able to understand
  • •the planned study procedures and (limited) risks associated with the study,
  • •inc. the risk of incidental findings in genetic analysis.
  • •3. The subject was enrolled in a CHMI study performed by the Radboudumc between
  • •January 1998 and December 2021 and was subjected to a Controlled Human Malaria
  • •Infection. Subject developed a cardiac serious adverse event in the period of
  • •20 days following CHMI. A cardiac SAE is defined as either clinically
  • •significant increased troponin levels and/or diagnosis of myocarditis, acute
  • •coronary syndrome or myocardial infarction by a cardiologist, and meet the
  • •criteria of an SAE as defined in the study protocol.
  • •4. Subjects unwilling and/or unable to participate in genetic analysis, are
  • •still eligible for immunological analysis (and vice versa).
  • •In order to be eligible to participate in this study as a control, a subject
  • •must meet all of the following criteria:
  • •1. The subject has signed written informed consent.
  • •2. The subject is able to understand the study procedures and (limited) risks
  • •associated with the study.
  • •3. The subject was enrolled in a CHMI study performed by the Radboudumc between
  • •January 1998 and December 2021 and was subjected to a Controlled Human Malaria
  • •Infection. Subject did not develop a cardiac serious adverse event in the
  • •period of 20 days following CHMI. A cardiac SAE is defined as either
  • •clinically significant increased troponin levels and/or diagnosis of
  • •myocarditis, acute coronary syndrome or myocardial infarction by a
  • •cardiologist, and meets the criteria of an SAE as defined in the respective
  • •study protocol.

Exclusion Criteria

  • •A potential case or control subject who meets any of the following criteria
  • •will be excluded from participation in immunological screening:
  • •1. Subject is HIV-positive or suffers from any other (acute or chronic) disease
  • •as determined by medical history, physical examination or laboratory screening
  • •tests which according to the clinical judgment of the investigator leads to
  • •undesirable interference with the results of the immunological tests. The
  • •clinical investigator will consider whether blood samples without such
  • •interference can be obtained later in the study period (e.g. in case of acute
  • •infectious disease).
  • •2. Use or receipt of
  • •i) immunosuppressive drugs or other immune modifying drugs within three months
  • •prior to blood sampling for immunological screening (inhaled and topical
  • •corticosteroids and oral anti-histamines exempted) OR
  • •ii) use of illicit drugs determined through urine drug screening OR
  • •iii) any vaccinations within 30 days prior to immunology blood sampling
  • •IF use of these drugs or receipt of a vaccination lead to undesirable
  • •interference with the results of the immunological tests according to the
  • •clinical judgment of the investigator. The clinical investigator will consider
  • •whether blood samples without such interference can be obtained later in the
  • •study period.
  • •3. Any history of malaria other than CHMI as part of the Radboudumc trial in
  • •which the subject has previously participated.
  • •A potential case subject who meets any of the following criteria will be
  • •excluded from participation in genetic analysis:
  • •1. A history of bone marrow transplantation.

Investigators

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