A Phase 2 interventional study of Artesunate and Malarone in Malaria, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in Kenya. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by U.S. Army Medical Research and Development Command · Phase 2, Interventional, and Treatment
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.
This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 30 is below the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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:
Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Drug: Artesunate · Drug: Malarone
Intravenous Artesunate (2.4 mg/kg) once a day for three days
Also known as: quinidine
(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
Also known as: atovaquone and proguanil hydrochloride
Change in Percentage of Parasites Detected at 48 Hours
Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases
Time frame: 48 hours
Percentage of Parasite Clearance
The target variable is detection (percentage) of asexual stage parasites of Plasmodium falciparum malaria in bloodstream by Giemsa - stained microscopy of thick and thin blood smears
Time frame: 24 and 48 hours post dose
Number of Subjects With Fever Clearance
Temperature is measured by oral digital thermometers, and fever clearance time is defined as the first time with resolution of fever (\<37.5C) sustained for 24 hours
Time frame: Within 48 hours post dose
Safety - Severity of Adverse Events
Determine the safety (defined as severity of AE's using the Common Toxicity Criteria)
Time frame: up to 14 days
Safety - Adverse Events Relationship to Study Drug
Determine the safety (defined as relationship to study drug of AE's and SAE's)
Time frame: up to 14 days
Safety - Severity of Serious Adverse Events (SAE's)
Determine the safety (defined as severity of SAE's using the Common Toxicity Criteria)
Time frame: up to 14 days
Safety - Serious Adverse Event (SAE) Relationship to Study Drug
Determine the safety (defined as relationship to study drug of SAE's)
Time frame: Up to 14 days
Thirty adult subjects with uncomplicated malaria were recruited from the endemic malarious region of Nyanza province in Kenya came to the New Nyanza Medical Center or sub-location recruitment sites.
| Milestone | Artesunate and Malarone |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases
| percentage of parasite change | Artesunate and Malarone |
|---|---|
| Change in Percentage of Parasites Detected at 48 Hours | 99.998 ± 0.0006 |
The target variable is detection (percentage) of asexual stage parasites of Plasmodium falciparum malaria in bloodstream by Giemsa - stained microscopy of thick and thin blood smears
| percentage of parasite clearance | Artesunate and Malarone |
|---|---|
| 24 hours post dose | 99.421 ± 1.365 |
| 48 hours post dose | 99.998 ± 0.0006 |
Temperature is measured by oral digital thermometers, and fever clearance time is defined as the first time with resolution of fever (\<37.5C) sustained for 24 hours
| Participants | Artesunate and Malarone |
|---|---|
| Number of Subjects With Fever Clearance | 29 |
Determine the safety (defined as severity of AE's using the Common Toxicity Criteria)
| Number of adverse events | Artesunate and Malarone |
|---|---|
| Mild | 123 |
| Moderate | 17 |
| Severe | 6 |
Determine the safety (defined as relationship to study drug of AE's and SAE's)
| Number of adverse events | Artesunate and Malarone |
|---|---|
| None or remote | 89 |
| Possible, probable, definate | 57 |
Determine the safety (defined as severity of SAE's using the Common Toxicity Criteria)
| Number of events | Artesunate and Malarone |
|---|---|
| Mild | 0 |
| Moderate | 0 |
| Severe | 1 |
Determine the safety (defined as relationship to study drug of SAE's)
| Number of events | Artesunate and Malarone |
|---|---|
| None or Remote | 0 |
| Possible, Probable, Definate | 1 |
Collected over 14 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Artesunate and Malarone | — | 1/30 (3.3%) | 30/30 (100%) |
| Event | Artesunate and Malarone |
|---|---|
| Stevens-Johnson SyndromeSkin and subcutaneous tissue disorders | 1/30 |
| Event | Artesunate and Malarone |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 16/30 |
| HypotensionVascular disorders | 9/30 |
| AnaemiaBlood and lymphatic system disorders | 8/30 |
| HypotensionVascular disorders | 8/30 |
| HeadacheNervous system disorders | 8/30 |
| PyrexiaGeneral disorders | 7/30 |
| AnaemiaBlood and lymphatic system disorders | 5/30 |
| BradycardiaCardiac disorders | 5/30 |
| TachycardiaCardiac disorders | 5/30 |
| EosinophiliaBlood and lymphatic system disorders | 4/30 |
| Age, Categorical(Participants) | Artesunate and Malarone |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 30 |
| >=65 years | 0 |
| Age, Continuous(years) | Artesunate and Malarone |
|---|---|
| Mean | 28 ± 9.4 |
| Sex: Female, Male(Participants) | Artesunate and Malarone |
|---|---|
| Female | 20 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Artesunate and Malarone |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 30 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Artesunate and Malarone |
|---|---|
| Tribe = Luo | 27 |
| Tribe = Luyha | 2 |
| Tribe = Other | 1 |
| Region of Enrollment(participants) | Artesunate and Malarone |
|---|---|
| Kenya | 30 |
Plan to share: No
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U.S. Army Medical Research and Development Command