Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT01055002
Eligibility Criteria:
Inclusion Criteria:
* Males aged 18-45 years who do not live alone
* BMI within 18-30
* Understand the procedures and risks involved
* Contactable for the duration of the study
* Non-smokers and in good health
* Good venous access
Exclusion Criteria:
* History of malaria
* Been in a malaria-endemic country within 12 months
* Evidence of cardiovascular risk
* Splenectomy
* History of severe allergic reactions after vaccination of infusion
* Any serious chronic illness
* Inherited genetic anomaly
* Any volunteers wishing to donate blood to the blood bank in the future
* Retinal or visual field changes
* Diagnosis of chronic severe psychiatric condition
* Hospitalisation within 5 years for psychiatric illness, suicide attempt or danger to self or others
* Receiving psychiatric drugs (some exceptions)
* Known QTc prolongation
* Family history of cardiac anomalies
* Recent or current therapy with an antibiotic or drug with potential antimalarial activity
* Known hypersensitivity to artemether or lumefantrine, atovaquone or proguanil hydrochloride or any of the excipients
* Concomitant use of any drug which is metabolised by the cytochrome enzyme CYP2D6 OR drugs that are known to prolong the QTc interval
* Use of corticosteroids, anti-inflammatory drugs, any immunomodulators or anticoagulants. Currently receiving or have previously received immunosuppressive therapy, including systemic steroids including ACTH or inhaled steroids in dosages which are associated with hypothalamicpituitary- adrenal axis suppression such as 1mg/kg/day of prednisone or its equivalent or chronic use of inhaled high potency corticosteroids
* Presence of acute infectious disease or fever
* Evidence of acute illness within the four weeks before trial prior to screening
* Significant intercurrent disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis
* Alcohol consumption greater than community norms
* A history of drug habituation, or any prior intravenous usage of an illicit substance
* Medical requirement for intravenous immunoglobulin or blood transfusions
* Participation in any investigational product study within the 8 weeks preceding the study
* Participation in any research study involving significant blood sampling, or blood donation to a blood bank during the 8 weeks preceding the study
* Have ever received a blood transfusion
* Positive test for HIV, Hepatitis B, hepatitis C, Human T-cell Lymphotropic Virus I \& II (HTLVI \& HTLVII), and syphilis
* Any clinically significant biochemical or haematologic abnormality (Hb must be ≥13.5g/dL)
* Ingestion of any poppy seeds within the 48 hours prior to the screening blood test
* Detection of any recreational drug listed in the urine drug screen
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01055002
Study Brief:
Protocol Section:
NCT01055002