Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

May 10, 2010 updated by: Makerere University

Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients

Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The current first line treatment for severe malaria in Uganda is intravenous quinine with artemisinin derivatives as an alternative. Intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. It is generally well tolerated and safe. This study aims is to assess the pharmacokinetics, pharmacodynamics and safety of IV artesunate in treatment of severe malaria in adults admitted to Mulago National Referral and Teaching hospital, Uganda.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda, 256
        • Mulago National Referral Hospital
        • Contact:
          • Pauline Byakika-Kibwika, MSc, MMed
          • Phone Number: +256 772 626885
          • Email: pbyakika@gmail.com
        • Contact:
        • Principal Investigator:
          • Pauline Byakika-Kibwika, MSc, MMed
        • Sub-Investigator:
          • Ceppie Merry, FRCP, PhD
        • Sub-Investigator:
          • Mohammed Lamorde, MBBS
        • Sub-Investigator:
          • Harriet Mayanja-Kizza, MSc, MMed
        • Sub-Investigator:
          • Celestino Obua, MSc, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population for this study are patients aged 18 years and above. The accessible population will be patients of 18 years and above who present to Mulago hospital with severe malaria. The study population will include patients aged 18 years and above presenting with severe malaria, who fulfill study eligibility criteria and are enrolled.

Description

Inclusion Criteria:

  1. Patients aged 18 years and above
  2. With severe malaria according to the following ciriteria:
  3. A positive blood smear for malaria with P. falciparum mono-infection with parasitemia > 500 parasites/ul of blood
  4. Who according to the attending physician require parenteral treatment and admission for malaria
  5. Willing to participate in the study
  6. Who are or whose first degree parents/caretakers are able to provide written informed consent

Exclusion Criteria:

  1. Patients with history of prior antimalarial use within the last 72 hours
  2. Pregnant women
  3. Patients with contraindications to taking the study drugs
  4. Patients taking known inhibitors or inducers of cytochrome P450 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
20 adults with severe malaria
20 adult patients admitted with severe malaria
Drug: intravenous artesunate
Intravenous artesunate in a dose of 2.4 mg/kg at start of treatment, 2.4 mg/kg 12 hours later and 2.4 mg/kg/day until the patient is able to tolerate oral therapy. The minimum duration of IV treatment will be 24 hours.
Other Names:
  • Artesun®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters; total area under the plasma concentration vs. time curve (AUC) of artesunate and DHA, maximum plasma concentration (Cmax), time to attain maximum concentration, elimination half life
Time Frame: 6 hours
Pharmacokinetic parameters for artesunate and dihydroartemisinin
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to 50% parasite clearance (PCT50)
Time Frame: 7 days
Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Makerere University

Investigators

  • Principal Investigator: Pauline Byakika-Kibwika, MSc, MMed, Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

September 1, 2010

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 13, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2010

Last Update Submitted That Met QC Criteria

May 10, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR 07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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