Falciparum Malaria Clinical Trial
Official title:
Safety, Feasibility, and Endothelial Effects of Sodium Nitrite Infusion in Children With Falciparum Malaria
Verified date | January 2021 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the safety of intravenous sodium nitrite in African children who have moderately severe malaria.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 4 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | Hubert Kairuki Memorial University | Dar es Salaam |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Heart, Lung, and Blood Institute (NHLBI) |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as measured by number of subjects with at least one adverse event | Adverse events will be assessed according to the NIH's Table for Grading the Severity of Adult and Pediatric Adverse Events. Events will be numerically graded 1-5; 1 being a mild event and 5 being death | 48 hours post infusion | |
Primary | Percent change in microvascular function/activation for each of the 4 dosing levels by linear regression | We will assess possible covariate relationships. A model will be developed that links the pharmacokinetics with the pharmacodynamic measures of endothelial function and activation | 48 hours post infusion |
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