Phase 2
N=30
Safety and Efficacy Study of IV Artesunate to Treat Malaria
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00298610 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Mar 2017
Primary outcome: Primary: Change in Percentage of Parasites Detected at 48 Hours — 99.998 percentage of parasite change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Artesunate (Drug); Malarone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Parasites Detected at 48 Hours |
99.998 | — |
| SECONDARY Percentage of Parasite Clearance |
99.421; 99.998 | — |
| SECONDARY Number of Subjects With Fever Clearance |
29 | — |
| SECONDARY Safety - Severity of Adverse Events |
123; 17; 6 | — |
| SECONDARY Safety - Adverse Events Relationship to Study Drug |
89; 57 | — |
| SECONDARY Safety - Severity of Serious Adverse Events (SAE's) |
0; 0; 1 | — |
| SECONDARY Safety - Serious Adverse Event (SAE) Relationship to Study Drug |
0; 1 | — |
Summary
The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.
Eligibility Criteria
Inclusion Criteria
- Adult male & non-pregnant females, 18-65 years
- Fever, defined as >37.5ºC, during the current illness, or history (within the last 48 hours) of fever.
- Diagnosis of falciparum malaria, greater than or equal to 200 parasites/uL
- Able to communicate well with the investigator and to comply with the requirements of the entire study.
- Willing to be admitted for the period of drug administration and/or to follow up (return to hospital)
- Provision of the written informed consent to participate as shown by a signature on the informed consent form.
Exclusion Criteria
- Administration of any investigational drug in the period 0 to 16 weeks before entry to the study.
- The use of any medication during the period 0 to 14 days (prescribed drugs) or 0 to 5 days (OTC) before entry to the study (including herbal or dietary supplements), except those deemed by the principal investigator / clinical investigator not to interfere with the outcome of the study.
- Existence of any surgical or medical condition that, in the judgment of the clinical investigator, might interfere with the distribution, metabolism or excretion of the drug.
- History of serious adverse reaction or hypersensitivity to study drug or follow on treatment.
- Mixed malaria infection (malaria other than falciparum malaria mono-infection as detected by screening blood smear)
- Severe falciparum malaria (as defined by the WHO; Attachment 1).
- Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study,
- Transfusion of blood within past 30 days.
- Refusal to prevent pregnancy during the 14 days of the trial
- Pregnancy as defined clinically or by a positive urine BHCG at the time of screening, or nursing mothers.
- Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary lab values:
- Creatinine >1.4 x ULN (>2.0 mg/dL)
- Glucose 3x ULN (120 U/L)
Data sourced from ClinicalTrials.gov (NCT00298610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.