Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria

NCT05750459

Plasmodium Falciparum Infection

COMPLETED PHASE4

Bio-availability of Rectal Artesunate in Children With Severe Falciparum Malaria

NCT02492178

Malaria

COMPLETED PHASE2

Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo

NCT00538382

Malaria

COMPLETED PHASE1

Safety and Preliminary Efficacy of L-arginine in Severe Falciparum Malaria

NCT00616304

Severe Falciparum Malaria

SUSPENDED PHASE2

Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials

NCT04009343

Uncomplicated Falciparum Malaria

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

20 adults with severe malaria

20 adult patients admitted with severe malaria

intravenous artesunate

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Artesun®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No