Safety and Efficacy Study of IV Artesunate to Treat Malaria

NCT ID: NCT00298610

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-10-31

Brief 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.

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).

Conditions

Malaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artesunate and Malarone

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.

Group Type: EXPERIMENTAL

Artesunate

Intervention Type: DRUG

Intravenous Artesunate (2.4 mg/kg) once a day for three days

Malarone

Intervention Type: DRUG

(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)

Interventions

Artesunate

Intravenous Artesunate (2.4 mg/kg) once a day for three days

Intervention Type: DRUG

Malarone

(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)

Intervention Type: DRUG

Other Intervention Names

quinidine; atovaquone and proguanil hydrochloride

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 <LLN (65mg/dL)
• AST, ALT >3x ULN (120 U/L)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military Infectious Diseases Research Program (MIDRP)

NETWORK

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shon A Remich, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Institute of Research (WRAIR)

Locations

New Nyanza Provincial Hospital

Kisumu, New Nyanza, Kenya

Countries

Kenya

Other Identifiers

KEMRI 917

Identifier Type: OTHER

Identifier Source: secondary_id

HSRRB A-13331

Identifier Type: OTHER

Identifier Source: secondary_id

WRAIR 1168

Identifier Type: -

Identifier Source: org_study_id