Status:
WITHDRAWN
Nitrite Infusion in Children With Malaria
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Falciparum Malaria
Eligibility:
MALE
4-10 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety of intravenous sodium nitrite in African children who have moderately severe malaria.
Detailed Description
This is a Phase I, open-label, dose-escalation study that will enroll up to 24 patients total, using a 3+3 dose escalation design, with 3 to 6 patients per dose level at up to 4 sequential dose levels...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent from parent or legal guardian
- Males, \>4 to 10 years of age
- Body weight \> 12 kg
- Parasitemia with Plasmodium falciparum including:
- Positive rapid diagnostic test result: AND
- \>2,500 parasites/microliter by microscopy
- Diagnosis of MSM, as follows:
- 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
- Exhibiting no WHO warning signs or criteria for SM \[27\]
- A negative G6PD deficiency test (careSTART G6PD quantitative biosensor)
- Requires inpatient parenteral treatment because of inability to tolerate oral therapy
- Hemoglobin \> 8 g/dL (subjects with prior blood transfusion will be eligible).
- Systolic blood pressure \> 85 mmHg
- Baseline quantitative methemoglobin measurement less than 2%
- Creatinine less than the upper limit of normal
Exclusion
- Female gender
- Diagnosis of severe malaria
- Presence of infection, or mixed infection, with non-falciparum strains of malaria
- 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%)
- Presence of concomitant non-malarial infection
- Known G6PD deficiency
- Known chronic illness including renal, cardiac, pulmonary, epilepsy
- History of a reaction to a substance or medication consisting of dyspnea and cyanosis
- History of trauma or bleeding in the 2 weeks prior to presentation
- Clinical impression of disseminated intravascular coagulation
- Subjects treated with parenteral anti-malarial drugs for more than 12 hours
- Current use of drugs with oxidative potential (e.g., nitrates, dapsone, primaquine); or drugs that cause hypotension.
- Known allergic reactions to sodium nitrite injection
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04289558
Start Date
June 1 2021
End Date
October 1 2021
Last Update
March 16 2021
Active Locations (1)
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1
Hubert Kairuki Memorial University
Dar es Salaam, Tanzania