Uncomplicated MalariaPhase 4NCT00845533
Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
A Phase 4 study testing Dihydroartemisinin-Piperaquine in people with Uncomplicated Malaria, run by University of California, San Francisco.
Trial summary
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Uncomplicated Malaria
- What is being tested?
- Dihydroartemisinin-Piperaquine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 4
- 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 6 months to 10 years
- All sexes
- Child
Who may be able to join
- Positive screening thick blood smear
- Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
- Age ≥ 6 months to 10 years
- Weight > 5 kg
- Absence of any history of serious side effects to study medications
- No evidence of a concomitant febrile illness in addition to malaria
Show all 10Show fewer
- No history of antimalarial use in the previous two weeks
- P. falciparum mono-infection
- Parasite density 2000-200,000/ul
- Provision of informed consent and ability to participate in 42-day follow-up
Who cannot join
- Danger signs or evidence of severe malaria
- Hemoglobin levels < 5.0 gm/dL
About this study
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.
- Conditions
- Uncomplicated Malaria
- Being tested
- Dihydroartemisinin-Piperaquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin-PiperaquineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Holley-Cotec Pharmaceuticals Co., LTD., Mahidol University
- Responsible party
- Principal investigator, Sunil Parikh, University of California, San Francisco
- Investigators
- Sunil Parikh, M.D., M.P.H., Principal investigator, University of California, San FranciscoPhilip J Rosenthal, M.D., Principal investigator, University of California, San FrancsicoJean-Bosco Ouedraogo, M.D., PhD, Principal investigator, Institut de Receherche en Sciences de la Sante Bobo-Dioulasso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845533
- Sponsor's protocol ID
- H40380-31179-01
- Status last verified
- Jan 2014
- First submitted
- 17 Feb 2009
- Last updated
- 16 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
- ClinicalTrials.gov ID
- NCT00845533
- Acronym / sponsor ID
- H40380-31179-01
- Conditions
- Uncomplicated Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Holley-Cotec Pharmaceuticals Co., LTD., Mahidol University
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Feb 2009 (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.
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (10 listed)
- Positive screening thick blood smear
- Fever (> 37.5ºC axillary) or history of fever in the previous 24 hours
- Age ≥ 6 months to 10 years
- Weight > 5 kg
- Absence of any history of serious side effects to study medications
Key exclusion criteria (2 listed)
- Danger signs or evidence of severe malaria
- Hemoglobin levels < 5.0 gm/dL
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 |
|---|---|---|
| Dihydroartemisinin-Piperaquine | Drug | – |
Primary outcome
Not reported in the source record.
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 16 Jan 2014.
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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.
Sunil Parikh, M.D., M.P.H. principal investigator
University of California, San Francisco
Philip J Rosenthal, M.D. principal investigator
University of California, San Francsico
Jean-Bosco Ouedraogo, M.D., PhD principal investigator
Institut de Receherche en Sciences de la Sante Bobo-Dioulasso
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dihydroartemisinin-Piperaquine in people with Uncomplicated Malaria, run by University of California, San Francisco.
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 10 inclusion and 2 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 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
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 16 Jan 2014.