Severe MalariaNCT01122134
Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment
An observational study of Severe Malaria, run by Makerere University at 1 site in Uganda.
Trial summary
Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Malaria
- What is being tested?
- intravenous artesunate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUganda
- Study dates
- May 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Mulago National Referral hospital
Kampala, 256
Pauline Byakika-Kibwika, MSc, MMed, +256 772 626885, pbyakika@gmail.com
Mohammed Lamorde, MBBS, +256 772 185590, mlamorde@idi.co.ug
About this study
Official title: 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
Read the 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.
- Conditions
- Severe Malaria
- Being tested
- intravenous artesunate
- Keywords
- severe, malaria, artesunate, intravenous
- Medical subject headings
- Malaria, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous artesunateDrug
Also called Artesun®
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.
| Study group | Role | What they receive |
|---|---|---|
| 20 adults with severe malaria | 20 adult patients admitted with severe malaria Receives: Drug: intravenous artesunate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours
Secondary outcomes (1)
Time to 50% parasite clearance (PCT50)
Time to 50% parasite clearance (PCT50) parasite clearance rates and clinical recovery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Investigators
- Pauline Byakika-Kibwika, MSc, MMed, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122134
- Sponsor's protocol ID
- CPR 07
- Status last verified
- May 2010
- First submitted
- 10 May 2010
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22540954
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients
- ClinicalTrials.gov ID
- NCT01122134
- Acronym / sponsor ID
- CPR 07
- Conditions
- Severe Malaria
- Keywords
- severe, malaria, artesunate, intravenous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 adults with severe malaria | – | Drug: intravenous artesunate20 adult patients admitted with severe malaria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous artesunateAlso: Artesun®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. | Drug | 20 adults with severe malaria |
Primary outcome
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
1 secondary outcome
Time to 50% parasite clearance (PCT50)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2010.
- Derived from this study: PubMed 22540954Byakika-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline Byakika-Kibwika, MSc, MMed principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Malaria, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2010.