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:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT03697668
Eligibility Criteria:
Inclusion Criteria:
1. Patients diagnosed with mild to moderate P. falciparum malaria
2. Adult male, age 18-55 years
3. Good health conditions other than malaria
4. The patient did not take anti-malarial drugs in the past 4 weeks
Exclusion Criteria:
1. unable to provide Informed Consent or Patient History Form
2. symptoms and signs of severe or complicated malaria including: continuous high fever over 39 °C, confusion, convulsions
3. parasitemia\<150.000 parasites /microliter
4. other neurological or psychiatric symptoms or disorders
5. abnormal bleeding
6. resting hearth rate lower than 60 and higher than 100 bpm
7. abnormal ECG, history of cardiac diseases
8. male adults with corrected QT intervals \> 450ms
9. signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system
10. hemoglobin \< 9.0 gm/100ml
11. symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.
12. patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption
13. concomitant infection by plasmodium species other than P. falciparum
14. inability to meet daily with local doctor during period of clinical trial
15. concomitant medicines like:
1. medicines used to treat high cholesterol in the blood (such as atorvastatin, lovastatin, simvastatin);
2. medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);
3. medicined used to treat HIV (antiretroviral medicines): protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine);
4. medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);
5. medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;
6. medicines used to prevent/treat epileptic seizures: barbiturates (such as phenobarbital), carbamazepine or phenytoin;
7. medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);
8. sex hormones, including those contained in hormonal contraceptives (such as gestodene, progesterone, estradiol), testosterone; - glucocorticoids (hydrocortisone, dexamethasone); - omeprazole (used to treat diseases related to gastric acid production);
9. paracetamol (used to treat pain and fever);
10. theophylline (used to improve bronchial air flow);
11. nefazodone (used to treat depression);
12. aprepitant (used to treat nausea);
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03697668
Study Brief:
Protocol Section:
NCT03697668