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 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT04289558
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent from parent or legal guardian
2. Males, \>4 to 10 years of age
3. Body weight \> 12 kg
4. Parasitemia with Plasmodium falciparum including:
1. Positive rapid diagnostic test result: AND
2. \>2,500 parasites/microliter by microscopy
5. Diagnosis of MSM, as follows:
1. Clinical syndrome consistent with malaria associated with documented fever (axillary temperature \>38C) or reported history of fever in the past 48 hours with no other cause present; AND
2. Exhibiting no WHO warning signs or criteria for SM \[27\]
6. A negative G6PD deficiency test (careSTART G6PD quantitative biosensor)
7. Requires inpatient parenteral treatment because of inability to tolerate oral therapy
8. Hemoglobin \> 8 g/dL (subjects with prior blood transfusion will be eligible).
9. Systolic blood pressure \> 85 mmHg
10. Baseline quantitative methemoglobin measurement less than 2%
11. Creatinine less than the upper limit of normal
Exclusion Criteria:
1. Female gender
2. Diagnosis of severe malaria
3. Presence of infection, or mixed infection, with non-falciparum strains of malaria
4. Signs of severe malaria\[27\], including 1 or more of the following:
* impaired consciousness (Blantyre coma score \<3 in children)
* prostration
* multiple convulsions (\>2 within 24 hours)
* acidosis (base deficit \>8 mEq/L or bicarbonate \<15 mmol/L or lactate \> 5 mmol/L)
* hypoglycemia (blood glucose \< 40 mg/dL or \<2.2 mmol/L)
* severe anemia (Hb \< 5g/dL )
* renal impairment (serum creatinine \>265 uMol/L or 3 mg/dL; or blood urea \>20 mmol/L)
* jaundice (bilirubin \>50 umol or 3 mg/dL with parasite count \>100000/ µL)
* pulmonary edema (including O2sat \<92% with RR \>30/min)
* circulatory collapse or shock
* significant bleeding
* hyperparasitemia (\>10%)
5. Presence of concomitant non-malarial infection
6. Known G6PD deficiency
7. Known chronic illness including renal, cardiac, pulmonary, epilepsy
8. History of a reaction to a substance or medication consisting of dyspnea and cyanosis
9. History of trauma or bleeding in the 2 weeks prior to presentation
10. Clinical impression of disseminated intravascular coagulation
11. Subjects treated with parenteral anti-malarial drugs for more than 12 hours
12. Current use of drugs with oxidative potential (e.g., nitrates, dapsone, primaquine); or drugs that cause hypotension.
13. Known allergic reactions to sodium nitrite injection
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
4 Years
Maximum Age:
10 Years
Study:
NCT04289558
Study Brief:
Protocol Section:
NCT04289558