ACTRN12613000669796
Completed
Phase 1
An Experimental Study To Characterise the in vivo Infectivity in Humans of the in vitro Expanded Blood Stage Plasmodium Falciparum Line QIMR3D7Pf
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- Queensland Institute of Medical Research
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants will be adults (males or non pregnant females), aged between 18 and 45 years who do not live alone (from Day 1 until at least the end of the antimalarial drug treatment).
- •2\. Participants must have a BMI within the range 18–30 kg/m2\.
- •3\. Participants must understand the procedures involved and agree to participate in the study by giving fully informed, written consent.
- •4\. Be contactable and available for the duration of the trial (maximum of 4 weeks).
- •5\. Participants must be non\-smokers and in good health, as assessed during pre\-study medical examination and by review of screening results.
- •6\. Female participants of childbearing potential, should be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the US FDA or TGA combined with a barrier contraceptive through completion of the study and have negative results on a serum or urine pregnancy test done before administration of study medication.
- •7\. Good peripheral venous access.
Exclusion Criteria
- •1\. History of malaria or tavelled to or lived (greater than 2 weeks) in a malaria\-endemic country during the past 12 months
- •2\. Has evidence of increased cardiovascular disease risk
- •3\. History of splenectomy.
- •4\. History of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion.
- •5\. Presence of current or suspected serious chronic diseases or significant intercurrent disease of any type
- •6\. Unwilling to defer blood donations for 6 months.
- •7\. Recent or current therapy with an antibiotic or drug with potential antimalarial activity (tetracycline, azthromycin, clindamycin, hydroxychloroquine etc.).
- •8\. Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6
- •9\. Use of corticosteroids, anti\-inflammatory drugs, any immunomodulators or anticoagulants.
- •10\. Presence of acute infectious disease or fever
Outcomes
Primary Outcomes
Not specified
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