Safety and Efficacy Study of IV Artesunate to Treat Malaria

NCT00298610 | Completed Phase 2 Results DMC

• 3 other identifiers: WRAIR 1168KEMRI 917HSRRB A-13331
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Uncomplicated Malaria; GMP artesunate

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Secondary Outcomes (6)

• Percentage of Parasite Clearance

  24 and 48 hours post dose

• Number of Subjects With Fever Clearance

  Within 48 hours post dose

• Safety - Severity of Adverse Events

  up to 14 days

• Safety - Adverse Events Relationship to Study Drug

  up to 14 days

• Safety - Severity of Serious Adverse Events (SAE's)

  up to 14 days

Study Arms (1)

Artesunate and Malarone

EXPERIMENTAL

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

Interventions

Artesunate DRUG

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

Also known as: quinidine

Artesunate and Malarone

Malarone DRUG

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

Also known as: atovaquone and proguanil hydrochloride

Artesunate and Malarone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Creatinine \>1.4 x ULN (\>2.0 mg/dL)
• Glucose \<LLN (65mg/dL)
• AST, ALT \>3x ULN (120 U/L)

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Military Infectious Diseases Research Program (MIDRP): collaborator

Study Sites (1)

New Nyanza Provincial Hospital

Kisumu, New Nyanza, Kenya

Location

MeSH Terms

Conditions

Malaria

Interventions

Artesunate; Quinidine; atovaquone, proguanil drug combination; Atovaquone; Proguanil

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Naphthoquinones; Quinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Shon A. Remich, MD
• Organization: Walter Reed Army Institute of Research

sremich@hotmail.com

254-733-628-670

Study Officials

• Shon A Remich, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2006
• First Posted: March 2, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 1, 2019
• Results First Posted: March 22, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)