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 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT00147368
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18-60 years
2. P. falciparum parasitemia (1,000-100,000 parasites/ul).
3. Clinical syndrome consistent with malaria associated with documented fever (axillary temperature \> 38℃) or self-reported history of fever in the last 48 hours with no other cause present
4. Commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine
5. An indication for hospital admission (eg relative cannot look after/supervise treatment at home but not having any warning signs or severe malaria criteria in "exclusion criteria" below)
6. Informed consent obtained
Exclusion Criteria:
1. Pregnancy or lactation
2. Mixed infection with P. falciparum and P. vivax
3. Warning signs of altered mental state and inability to sit unaided
4. Features of severe/complicated malaria
5. Diabetes
6. Systolic blood pressure (BP) \< 100 mmHg
7. Serious underlying disease (cardiac, hepatic, kidney)
8. Initial iSTAT test showing any of the following values:
* glucose \< 4 mmol/L;
* K+ ≥ 4.2 meq/L;
* Cl- \> 106 meq/L;
* HCO3- \< 20 meq/L.
9. Known allergy to L-arginine
10. Concurrent therapy with any of the following medications:
* spironolactone;
* oral nitrates;
* phosphodiesterase inhibitor (eg sildenafil \[Viagra\]);
* alpha-blocking antihypertensive agents (eg prazosin);
* L-arginine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00147368
Study Brief:
Protocol Section:
NCT00147368