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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT01836458
Eligibility Criteria:
Key Inclusion Criteria:
* Monoinfection with P. falciparum confirmed by microscopy
* Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
* Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
* Body weight between 40 to 90 kg
Key Exclusion Criteria:
* Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
* Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
* Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
* History of antimalarial use within 2 months of screening
* Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
* Long QT syndrome or QTc using Fridericia's formula \>430 msec
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* Hemoglobin level \<10 g/dL
* Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) \>2 times the upper limit of normal
* Renal dysfunction as indicated by serum creatinine \>2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be \<2 times the upper limit of normal after oral or parental rehydration
* Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
* Known history of hepatitis B or C; testing is not required
* Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
* Severe vomiting defined as \>3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
* Severe malnutrition defined by a body mass index (BMI) \<18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
* Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT01836458
Study Brief:
Protocol Section:
NCT01836458