MalariaPhase 2NCT00298610
Safety and Efficacy Study of IV Artesunate to Treat Malaria
A Phase 2 study testing Artesunate and Malarone in people with Malaria, run by U.S. Army Medical Research and Development Command at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malaria
- What is being tested?
- Artesunate and Malarone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteKenya
- Study dates
- Mar 2006to Oct 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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.
- Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary lab values:
- Creatinine >1.4 x ULN (>2.0 mg/dL)
- Glucose <LLN (65mg/dL)
- AST, ALT >3x ULN (120 U/L)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open Label, Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Artesunate in Adults With Uncomplicated Malaria
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.
Read the detailed description
This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).
- Conditions
- Malaria
- Being tested
- Artesunate, Malarone
- Keywords
- Uncomplicated Malaria, GMP artesunate
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesunateDrug
Also called quinidine
Intravenous Artesunate (2.4 mg/kg) once a day for three days
MalaroneDrug
Also called atovaquone and proguanil hydrochloride
(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Artesunate; Drug: Malarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Secondary outcomes (6)
Percentage of Parasite Clearance
The target variable is detection (percentage) of asexual stage parasites of Plasmodium falciparum malaria in bloodstream by Giemsa - stained microscopy of thick and thin blood smears
Measured: 24 and 48 hours post dose
Number of Subjects With Fever Clearance
Temperature is measured by oral digital thermometers, and fever clearance time is defined as the first time with resolution of fever (<37.5C) sustained for 24 hours
Measured: Within 48 hours post dose
Safety - Severity of Adverse Events
Determine the safety (defined as severity of AE's using the Common Toxicity Criteria)
Measured: up to 14 days
Safety - Adverse Events Relationship to Study Drug
Determine the safety (defined as relationship to study drug of AE's and SAE's)
Measured: up to 14 days
Safety - Severity of Serious Adverse Events (SAE's)
Determine the safety (defined as severity of SAE's using the Common Toxicity Criteria)
Measured: up to 14 days
Safety - Serious Adverse Event (SAE) Relationship to Study Drug
Determine the safety (defined as relationship to study drug of SAE's)
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Military Infectious Diseases Research Program (MIDRP)
- Responsible party
- Sponsor
- Investigators
- Shon A Remich, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298610
- Sponsor's protocol ID
- WRAIR 1168
- Other IDs
- KEMRI 917, HSRRB A-13331
- Status last verified
- Nov 2016
- First submitted
- 1 Mar 2006
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Artesunate in Adults With Uncomplicated Malaria
- ClinicalTrials.gov ID
- NCT00298610
- Acronym / sponsor ID
- WRAIR 1168
- Conditions
- Malaria
- Keywords
- Uncomplicated Malaria, GMP artesunate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Military Infectious Diseases Research Program (MIDRP)
- Study start
- Mar 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 2 Mar 2006 (estimated)
- Results
- Posted 22 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artesunate and Malarone | Experimental | Drug: Artesunate, Drug: MalaroneSubject 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
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 |
|---|---|---|
| ArtesunateAlso: quinidineIntravenous Artesunate (2.4 mg/kg) once a day for three days | Drug | Artesunate and Malarone |
| MalaroneAlso: atovaquone and proguanil hydrochloride(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days) | Drug | Artesunate and Malarone |
Primary outcome
Change in Percentage of Parasites Detected at 48 Hours
Time frame: 48 hours
Change in Percentage of Parasites Detected at 48 Hours. With positive numbers to represent increases and negative numbers to represent decreases
6 secondary outcomes
Percentage of Parasite Clearance
Time frame: 24 and 48 hours post dose
Number of Subjects With Fever Clearance
Time frame: Within 48 hours post dose
Safety - Severity of Adverse Events
Time frame: up to 14 days
Safety - Adverse Events Relationship to Study Drug
Time frame: up to 14 days
Safety - Severity of Serious Adverse Events (SAE's)
Time frame: up to 14 days
Safety - Serious Adverse Event (SAE) Relationship to Study Drug
Time frame: Up to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Shon A Remich, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate and Malarone in people with Malaria, run by U.S. Army Medical Research and Development Command at 1 site in Kenya.
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 14 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: finished, as of the sponsor's last update on 1 Oct 2019. 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 Kenya. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of Parasites Detected at 48 Hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2019.