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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007104 |
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Date of registration:
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08/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Haemolysis after antimalarial treatment with artemisinins and other antimalarial drugs
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Scientific title:
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Haemolysis after antimalarial treatment with artemisinins and other antimalarial drugs - HAEMOART |
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Date of first enrolment:
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01/05/2014 |
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Target sample size:
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150 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007104 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Gabon
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Germany
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Contacts
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Name:
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Florian
Kurth |
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Address:
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Charitéplatz 1
10117
Berlin
Germany |
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Telephone:
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004930450665023 |
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Email:
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florian.kurth@charite.de |
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Affiliation:
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Medizinische Klinik mit Schwerpunkt Infektiologie und PneumologieCharité - Universitätsmedizin Berlin |
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Name:
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Florian
Kurth |
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Address:
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Charitéplatz 1
10117
Berlin
Germany |
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Telephone:
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03045050 |
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Email:
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florian.kurth@charite.de |
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Affiliation:
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Infektiologie und Pneumologie, Charité Universitätemedizin Berlin |
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Key inclusion & exclusion criteria
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Inclusion criteria: Adult or paediatric patient with microscopically confirmed malaria and intention for antimalarial treatment
Patient or legal guardian able to provide informed consent
Patient able and willing to complete follow-up examinations at least until Day 21
Exclusion criteria: Having taken antimalarial drugs for malaria treatment 12 weeks prior to study inclusion (exclusive of prophylaxis)
Having taken medication with haemolytic potential 12 weeks prior to inclusion
Active Lymphoproliferative diseases (e.g., Lymphoma, Myeloma)
Active rheumatic diseases
History of autoimmunhaemolytic anaemia
Known G6-PD deficiency
Sickle cell anaemia or other known haemoglobinopathy
Mechanical heart valve replacement
Age minimum:
None
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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B50
B53
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Other parasitologically confirmed malaria
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Plasmodium falciparum malaria
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Intervention(s)
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Group 1: Patients with malaria will be examined for clinical or laboratory signs of haemolysis - twice during treatment and twice during the two weeks after treatment
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Primary Outcome(s)
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Occurrence of clinical or laboratory-diagnosed haemolysis not attributable to malaria in a period of six weeks after the first dose of antimalarial treatment
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Secondary Outcome(s)
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Any other adverse drug reactions, the degree of haemolysis in relation to risk factors, the duration of haemolysis, immunohaematologic parameters
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Source(s) of Monetary Support
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Charité Campus Virchow-Klinikum
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Ethics review
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Status: Approved
Approval date: 23/01/2014
Contact:
ethikkommission@charite.de
Ethikkommission der Charité – Universitätsmedizin Berlin
(+49)30-450517222
ethikkommission@charite.de
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