Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

NCT01122134 | Unknown

• 1 other identifier: CPR 07
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Severe Malaria

Keywords

severe; malaria; artesunate; intravenous

Outcome Measures

Primary Outcomes (1)

• 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

  Pharmacokinetic parameters for artesunate and dihydroartemisinin

  6 hours

Secondary Outcomes (1)

• Time to 50% parasite clearance (PCT50)

  7 days

Study Arms (1)

20 adults with severe malaria

20 adult patients admitted with severe malaria

Drug: intravenous artesunate

Interventions

intravenous artesunate DRUG

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.

Also known as: Artesun®

20 adults with severe malaria

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Mulago National Referral hospital

Kampala, 256, Uganda

Location

Related Publications (1)

• Byakika-Kibwika P, Lamorde M, Mayito J, Nabukeera L, Mayanja-Kizza H, Katabira E, Hanpithakpong W, Obua C, Pakker N, Lindegardh N, Tarning J, de Vries PJ, Merry C. Pharmacokinetics and pharmacodynamics of intravenous artesunate during severe malaria treatment in Ugandan adults. Malar J. 2012 Apr 27;11:132. doi: 10.1186/1475-2875-11-132.

  PMID: 22540954 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected for artesunate drug assays

MeSH Terms

Conditions

Malaria; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pauline Byakika-Kibwika, MSc, MMed

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 13, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 13, 2010

Record last verified: 2010-05

Locations

UG (1)