Falciparum MalariaPhase 2NCT00459615
Phase II Dose Ranging Study of Artesunate
A Phase 2 study testing Artesunate for Injection in people with Falciparum Malaria and Uncomplicated Malaria, run by U.S. Army Office of the Surgeon General at 2 sites in 2 countries.
Trial summary
The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most effective treatment regimen as determined by rapidity of parasite clearance by microscopy. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Falciparum Malaria, Uncomplicated Malaria
- What is being tested?
- Artesunate for Injection
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2007to Jan 2008
- Phase
- Phase 2
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute symptomatic Plasmodium falciparum malaria infection as determined by malaria smear with a parasite density of ≥ 5000 asexual parasites/mL
- Age: 5-65 year old males and females.
- Written informed consent must be obtained from adults age > 18 years. Parental consent will be obtained from children and adolescents, and subject assent will also be obtained from adolescents (age 12-17 years).
- Willing to stay hospitalized for 4 days for treatment and for 3 scheduled follow-up outpatient visits at Day 7, 14 and 28.
Who cannot join
- Pregnant women (clinically or by positive urine β-HCG) and nursing mothers
- Clinical evidence of severe malaria (see Appendix B)
- Mixed malaria infection on admission by malaria smear
- A previous history of intolerance or hypersensitivity to the study drug artesunate or other artemisinin derivatives or Malarone.
- Efficacious malaria drug therapy administered in the past 30 days by history (i.e. quinine, mefloquine, lumefantrine and artemisinin derivatives)
- Previous participation in this trial or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
Show all 10Show fewer
- Laboratory evidence or a history of significant liver or renal functional abnormality.
- Anyone who has received a transfusion or any blood product within 30 days
- Unable and/or unlikely to comprehend and/or follow the protocol.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase II, Randomized, Open-Label, Dose-Ranging Study of Intravenous Artesunate Therapy for the Treatment of Acute, Uncomplicated Plasmodium Falciparum Malaria.
The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most effective treatment regimen as determined by rapidity of parasite clearance by microscopy.
Read the detailed description
To compare the efficacy and tolerability of intravenous artesunate for the initial treatment of uncomplicated Plasmodium falciparum malaria at doses that bracket anticipated clinical doses (2.4 mg/kg once daily for 3 days; or 2.4 mg/kg initially, at 12 hours on Day 0, and then daily on Day 1 and 2) and thereby establish the safest, highly efficacious dosing regimen for use in future clinical trials.
- Conditions
- Falciparum Malaria, Uncomplicated Malaria
- Being tested
- Artesunate for Injection
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate for InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for this pharmacodynamic study is clearance of falciparum parasites from the blood.
Reference microscopic interpretation of Giemsa-stained thick and thin blood smears for malaria will serve as the diagnostic method of parasitemia detection.
Parasite clearance will be quantified using a discrete variable denoting efficacy to clear at least 90% of asexual parasites from the peripheral blood by 48 hours after administration of IV artesunate
Secondary outcomes (5)
Additional measures of parasite clearance will also be assessed.
A continuous variable of time to parasite reduction milestones:
parasite clearance time (PCT90 and PCT100), and parasite reduction ratios (PRR12h and PRR24h) at defined time points , and
A continuous variable of area under the curve (AUC) of quantifiable parasitemia
Tolerability of the treatment regimens will also be assessed throughout the study through use of evaluation for adverse events and safety laboratories to include hematology and chemistry tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Falciparum 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Office of the Surgeon General
- Sponsor type
- US federal agency
- Collaborators
- Military Infectious Diseases Research Program (MIDRP), U.S. Army Medical Research and Development Command
- Investigators
- Mark Polhemus, MD, Principal investigator, USAMRU-KBryan Smith, MD, Principal investigator, Armed Forces Research Institute of Medical Sciences, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459615
- Sponsor's protocol ID
- WRAIR 1263
- Other IDs
- HSRRB Protocol Log#A-13912a,b
- Status last verified
- Sep 2008
- First submitted
- 10 Apr 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-Label, Dose-Ranging Study of Intravenous Artesunate Therapy for the Treatment of Acute, Uncomplicated Plasmodium Falciparum Malaria.
- ClinicalTrials.gov ID
- NCT00459615
- Acronym / sponsor ID
- WRAIR 1263
- Conditions
- Falciparum Malaria, Uncomplicated Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- U.S. Army Office of the Surgeon GeneralUS federal agency
- Collaborators
- Military Infectious Diseases Research Program (MIDRP), U.S. Army Medical Research and Development Command
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Apr 2007 (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.
The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most effective treatment regimen as determined by rapidity of parasite clearance by microscopy.
Detailed description
To compare the efficacy and tolerability of intravenous artesunate for the initial treatment of uncomplicated Plasmodium falciparum malaria at doses that bracket anticipated clinical doses (2.4 mg/kg once daily for 3 days; or 2.4 mg/kg initially, at 12 hours on Day 0, and then daily on Day 1 and 2) and thereby establish the safest, highly efficacious dosing regimen for use in future clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Acute symptomatic Plasmodium falciparum malaria infection as determined by malaria smear with a parasite density of ≥ 5000 asexual parasites/mL
- Age: 5-65 year old males and females.
- Written informed consent must be obtained from adults age > 18 years. Parental consent will be obtained from children and adolescents, and subject assent will also be obtained from adolescents (age 12-17 years).
- Willing to stay hospitalized for 4 days for treatment and for 3 scheduled follow-up outpatient visits at Day 7, 14 and 28.
Key exclusion criteria (10 listed)
- Pregnant women (clinically or by positive urine β-HCG) and nursing mothers
- Clinical evidence of severe malaria (see Appendix B)
- Mixed malaria infection on admission by malaria smear
- A previous history of intolerance or hypersensitivity to the study drug artesunate or other artemisinin derivatives or Malarone.
- Efficacious malaria drug therapy administered in the past 30 days by history (i.e. quinine, mefloquine, lumefantrine and artemisinin derivatives)
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 |
|---|---|---|
| Artesunate for Injection | Drug | – |
Primary outcome
The primary endpoint for this pharmacodynamic study is clearance of falciparum parasites from the blood.
Reference microscopic interpretation of Giemsa-stained thick and thin blood smears for malaria will serve as the diagnostic method of parasitemia detection.
Parasite clearance will be quantified using a discrete variable denoting efficacy to clear at least 90% of asexual parasites from the peripheral blood by 48 hours after administration of IV artesunate
5 secondary outcomes
Additional measures of parasite clearance will also be assessed.
A continuous variable of time to parasite reduction milestones:
parasite clearance time (PCT90 and PCT100), and parasite reduction ratios (PRR12h and PRR24h) at defined time points , and
A continuous variable of area under the curve (AUC) of quantifiable parasitemia
Tolerability of the treatment regimens will also be assessed throughout the study through use of evaluation for adverse events and safety laboratories to include hematology and chemistry tests.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2008.
- Related InfoLink provided by the sponsor.
Related trials for Falciparum Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral
Not yet recruitingPhase 1
Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
Malaria Vaccine
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.
Mark Polhemus, MD principal investigator
USAMRU-K
Bryan Smith, MD principal investigator
Armed Forces Research Institute of Medical Sciences, Thailand
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Artesunate for Injection in people with Falciparum Malaria and Uncomplicated Malaria, run by U.S. Army Office of the Surgeon General at 2 sites in 2 countries.
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 4 inclusion and 10 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 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya, Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint for this pharmacodynamic study is clearance of falciparum parasites from the blood.. The study lists 3 primary outcomes in all. 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 25 Sep 2008; AzTrials last refreshed its copy on 6 Nov 2026.