Safety and Efficacy Study of IV Artesunate to Treat Malaria - Full Text View

Sponsors and Collaborators:	U.S. Army Office of the Surgeon General Military Infectious Diseases Research Program (MIDRP)
Information provided by:	Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier:	NCT00298610

Purpose

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.

Condition	Intervention	Phase
Malaria	Drug: Artesunate	Phase II

MedlinePlus related topics: Malaria

Drug Information available for: Artesunate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Phase II, Open Label, Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Artesunate in Adults With Uncomplicated Malaria

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:

PK of artesunate and dihydroartemisinin

Secondary Outcome Measures:

Parasite clearance time
Fever clearance time

Estimated Enrollment:	30
Study Start Date:	March 2006
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Detailed Description:

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).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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/l
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 -HCG 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
- Creatinine > 1.4 x ULN (>2.0 mg/dl)
- Glucose < LLN (65mg/dl)
- AST, ALT > 3x ULN (120 U/L

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298610

Locations

Kenya, New Nyanza
New Nyanza Provincial Hospital
Kisumu, New Nyanza, Kenya

Sponsors and Collaborators

U.S. Army Office of the Surgeon General

Military Infectious Diseases Research Program (MIDRP)

Investigators

Principal Investigator:

Shon A Remich, MD

Walter Reed Army Institute of Research (WRAIR)

More Information

Study ID Numbers:	WRAIR 1168, KEMRI 917, HSRRB A-13331
Study First Received:	March 1, 2006
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00298610
Health Authority:	United States: Food and Drug Administration

Keywords provided by Walter Reed Army Institute of Research (WRAIR):

Uncomplicated Malaria
GMP artesunate

Study placed in the following topic categories:

Artesunate
Protozoan Infections
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Amebicides
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009